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Section I – Introduction Version 1 of 2

VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS Section I

Introduction

The Ayush products are regulated under the Drugs and Cosmetics Act, 1940 by the Drugs Controller General of India through the State Governments. The Department of AYUSH has been exploring the possibility of introducing a voluntary product certification scheme for selected AYUSH products to enhance consumer confidence. The matter was discussed in a series of meetings taken by the Secretary (AYUSH) beginning 24 Dec 2008 and the Quality Council of India (QCI) offered to develop a concept paper on the subject. On approval of the concept, the Department of AYUSH signed an agreement with the QCI on 27 July 2009 to design the Scheme with Department of AYUSH being the Scheme owner and QCI being responsible for managing the Scheme. The draft Scheme was given to the Department of AYUSH on 3 Aug 2009 and simultaneously placed on the websites of Department of AYUSH and QCI for public consultation. The Scheme will be overseen by a Multistakeholder Steering Committee (MSC) chaired by the Secretary (AYUSH) with secretariat in QCI. The MSC will be supported by a Technical Committee and a Certification Committee constituted by QCI.

The Scheme is based on a criteria for certification. It has two levels:

a. Ayush Standard Mark which is based on compliance to the domestic

regulatory requirements b. Ayush Premium Mark which is based on GMP requirements based

on WHO Guidelines and product requirements with flexibility to certify against any overseas regulation provided these are stricter than the former criteria.

Section I – Introduction Version 1 of 2

Under this scheme, each manufacturing unit would obtain a certification from a approved certification body (CB) which is accredited to appropriate international standards by the National Accreditation Board For Certification Bodies (NABCB) and will be under regular surveillance of the certification body. The documentation of the Scheme is as follows:

Section Title I Introduction II Governing Structure III Certification Criteria III A GMP Requirements Based On WHO Guidelines for

Ayush Premium Mark

III B Permissible Levels of Contaminants for Ayush Premium Mark

III C Permissible Levels of Contaminants for Ayush Standard Mark

IV Certification Process IV A Internal Quality Assurance Protocol V Requirements for Certification Bodies VI Obtaining and Maintaining Certification VII Approval for use of Certification Mark to Certified Units

Section II – Governing Structure Version 1 Page 1 of 6

VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS

Section II GOVERNING STRUCTURE

1. SCOPE OF THIS DOCUMENT

This document explains the governing structure of the Voluntary Certification Scheme for AYUSH Products (also referred to as ‘the Scheme’) and the roles and responsibilities of various organizations and committees involved in operating the Scheme.

2. OBJECTIVE

The objective of this document is to clearly define the roles of various organizations/committees involved in the operation of the Scheme.

3. GOVERNING STRUCTURE 3.1 The governing structure of Voluntary Certification Scheme for Ayush Products shall

have a Multistakeholder Steering Committee (MSC) at the apex level supported by a Technical and a Certification Committee each with its secretariat in the Quality Council of India (referred to as QCI hereinafter)

3.2 The governing structure is depicted schematically in Fig 1. 4. APPOINTMENT OF COMMITTEES – GENERAL RULES

In the appointment of various committees, the following general principles shall be kept in mind:

a) representation of a balance of interests such that no single interest predominates. b) key interests to include: representatives of Ayush industry associations, Certification

Bodies, Testing Laboratories, Accreditation bodies, representatives of regulatory bodies or other governmental agencies, Academic / Research Bodies and representatives of non-governmental organizations.

c) Offer of membership to individual experts shall be made with great caution and only when a suitable person is not forthcoming as a representative of an organization

d) Except when a member is appointed in his personal capacity, a person vacates his membership on leaving his organization and a fresh nomination is sought from the member organization.

e) the member organizations shall nominate a principal and an alternate representative on the committee(s).

f) all committees shall be reconstituted every 2 years to provide representation to organizations like State Governments, Certification Bodies etc. by rotation, where necessary.


FIG 1 5. MULTISTAKEHOLDER STEERING COMMITTEE (MSC) 5.1 Membership - The MSC shall comprise of the following; a) Secretary, Department of AYUSH - Chairperson; b) Central Government Ministries - One Representative each from the concerned

Ministries – Department of Commerce, Department of Consumer Affairs, Department of Health, Department of Forests, MOEF, and Department of AYUSH;

c) Regulatory Bodies - Drugs Controller General of India d) Accreditation Bodies – One Representative each from NABCB and NABL; e) Industry Bodies – One industry body of each stream of AYUSH – Ayurveda, Unani,

Siddha and Homeopathy f) State Governments – 3 (by rotation for 2 years) ; g) Testing Laboratories – 3 - One Representative each from PLIM, HPL, and IIIM,

Jammu h) Certification Bodies – One representative from QCI accredited bodies (2 years by

rotation) i) Research bodies – 2 (2 years by rotation)


j) Chairman APC k) NMPB ( 2 years by rotation) l) Professional Bodies of practitioners of each discipline – One Representative from each

stream of Ayush Practitioners m) Representative of Drug Retail Trade Association n) Secretary General, QCI o) Any other Technical expert(s) as invitees for specific meetings, as identified by the

Secretariat. p) Secretariat – Quality Council of India 5.1.1 MSC may coopt any other members. 5.2 Terms of reference - The MSC is responsible for ; a) Overall development, modification and supervision of the Scheme b) Receiving recommendations of the Technical/Certification Committees and deciding on

them c) Constituting any committees, as needed 5.3 Meetings - The MSC shall meet at least once every year. 6 TECHNICAL COMMITTEE (TC) 6.1 Membership – The Technical Committee shall comprise of the following; a) Chairperson b) Central Council For Research In Ayurveda and Siddha c) Certification Body - One from those represented on the MSC d) Pharmacopeial Laboratory for Indian Medicines (PLIM) e) Industry Bodies - One of each stream of AYUSH f) Pharmexcil Export Promotion Council - One Representative g) Department of Ayush - One Representative h) DCGI - One Representative i) Accreditation Bodies – One Representative each from NABCB and NABL j) Research body from MSC - One k) Secretariat – Quality Council of India 6.1.1 TC may coopt more members. 6.2 Terms of reference - The Technical Committee is responsible for a) Defining the certification criteria and resolving any related issues; b) Assisting the Certification Committee in finalizing the Internal Quality Assurance

Protocol , for controlling the processes and production of Ayush products. 6.3 Meetings - The TC shall meet at least once every year.


7 CERTIFICATION COMMITTEE (CC) 7.1 Membership - The Certification Committee shall comprise of the following: a) Chairperson b) Department of Ayush - One Representative c) Certification Body – 2 CBs by rotation d) Accreditation Boards – One Representative each from NABCB and NABL e) DCGI f) EIC g) Industry - One of each stream of AYUSH h) Pharmexcil i) PLIM j) Secretariat – Quality Council of India 7.1.1 CC may coopt more members. 7.2 Terms of reference - The Certification Committee is responsible for a) Developing, maintaining and revising as appropriate the certification scheme b) Developing a guidance document to assist manufacturers to apply for Voluntary

Certification for Ayush Products. c) Developing, maintaining and revising as appropriate the requirements for certification

bodies for the operation of the Voluntary Certification for Ayush Products. d) Developing, maintaining and revising as appropriate the generic Internal Quality

Assurance Protocol for controlling the processes and production of Ayush products. e) Developing, maintaining and revising as appropriate the process for permitting certified

units for use of Certification mark. f) Any other issue relating to certification 7.3 Meetings - The Certification Committee shall meet at least once every year. 8. ROLES OF ORGANIZATIONS

Department of AYUSH shall be the Scheme Owner and own the Certification Mark(s). It shall establish the MSC while the management of the Scheme shall be the responsibility of QCI. Quality Council of India (QCI) shall provide the secretariat to the Scheme and the MSC. It shall set up the Technical and Certification Committees and provide secretariat to them. It shall also manage the Scheme on behalf of Department of AYUSH. National Accreditation Board for Certification Bodies (NABCB) shall be responsible for accrediting certification bodies desirous of participating in the Scheme to appropriate international standards National Accreditation Board for Testing and Calibration Laboratories (NABL) shall be responsible for accrediting testing and calibration laboratories to appropriate international standards to support the Scheme


9. The arrangements for the operation of the Voluntary certification for Ayush Products is

as outlined in Fig 2;

DEPARTMENT OF AYUSH

AYUSH VOLUNTARY CERTIFICATION

SCHEME( QCI SECRETARIAT)

APPROVEDCERTIFICATION

BODY (CB)NABCB

NABL ACCREDITED

LABORATORIES

APPLICANT FOR CERTIFICATION - AYUSH

PRODUCT MANUFACTURING UNIT

APPROVAL FORUSE OF

CERTIFICATION MARK(S)

ACCREDITATION

TESTING OF SAMPLESCERTIFY

NABL

ACCREDITATION

FIG. 2 10. COMPLAINTS 10.1 The entire system has provisions for entertaining complaints from any stakeholder

against any component of the Scheme – the manufacturing units certified under the Scheme, the Certification Bodies approved under the Scheme, the laboratories utilized under the Scheme, and the accreditation bodies, NABCB/NABL, are all required to have a complaints system in place as per standards applicable to them. Anyone having a complaint is encouraged to utilise the available mechanisms.

10.2 Any complaint received directly by the Department of AYUSH shall be referred to QCI

who in turn will make a reference to the appropriate body against which the complaint is made and monitor it till it is decided upon.

10.3 Any complaint received by QCI shall be similarly handled.


10.4 A statement on complaints as received above with their status shall be reported to the

MSC in each meeting. 11. APPEALS 11.1 There are provisions for entertaining appeals from the manufacturing units

certified/desirous of certification under the Scheme, the Certification Bodies approved under the Scheme, and the laboratories utilized under the Scheme, which shall invariably be utilized.

11.2 In case any one aggrieved by the decision of the TC/CC appeals, it shall be handled

by the MSC. 11.3 In case any one aggrieved by the decision of MSC appeals, the Chairperson, MSC

shall appoint an independent appeals panel to look into the appeal and recommend action to him/her

11.4 In handling appeals, the broad principle that the appeal is handled independently of

the personnel involved in the decision appealed against shall be maintained. 11.5 A statement of appeals received by the Department of AYUSH/QCI shall be placed

before the MSC in each meeting.

Section III – Certification Criteria Version 1 Page 1 of 1

SECTION III VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS

Certification Criteria

1.1 This document describes the requirements against which certification can be obtained under the Voluntary Certification Scheme for Ayush Products. The certification is available at two levels:

a) Ayush Standard Mark which is based on compliance to the domestic regulatory requirements; and

b) Ayush Premium Mark which is based on either or both of the following options; Option A: Compliance to GMP Requirements based on WHO Guidelines and Levels of contaminants as given in Certification Criteria document . Note

i. The requirements of heavy metals shall not be applicable to Ayush products having raw materials of metallic origin provided they are intended for domestic market.

ii. For the time being this certification is available for Herbal products only. Option B: Compliance to regulatory requirements of any importing country provided they are more stringent than Option A above. Note i. For the time being this certification is available for Herbal products

1.1.1 For any manufacturer to qualify for Ayush Premium Mark certification, compliance to the domestic regulation is a prerequisite. 1.2 The various criteria mentioned above are as follows:

a) Domestic regulation means regulatory requirements prescribed under the Drugs and Cosmetics Act, 1940 for AYUSH products

b) GMP Requirements based on WHO Guidelines for Ayush Premium Mark (Annex A)

c) Permissible levels of contaminants for AYUSH Premium Mark (Annex B) d) Permissible levels of contaminants for AYUSH Standard Mark (Annex C ) e) Regulations of importing countries – to be identified by the organization seeking

certification and provided to the Certification Body

Section III Annex A GMP Requirements Version 1 Page 1 of 20

Annex A SECTION III

VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS Certification Criteria

GMP Requirements Based On WHO Guidelines

for Ayush Premium Mark 1. Introduction The increasing use of herbal medicines and the growing demand of the global market for such products has raised concerns on the quality and safety of herbal materials and finished herbal products with the respective national health authorities. Although traditional systems of medicine have been recognized and accepted in most countries, efforts to provide validated techniques to ensure the quality, safety and efficacy of products are being developed. The quality of the finished herbal products is largely dependent and influenced by the quality of the raw materials used. Because herbal ingredients are of complex and variable nature, the requirements and methods for quality control of finished products specially for combination product poses an additional challenge as to how quality can be demonstrated. Therefore controls of starting material, storage and processing assume particular importance in the manufacturing process of herbal medicinal products. Unlike conventional pharmaceutical products, which are usually produced from synthetic materials by means of reproducible manufacturing techniques and procedures, herbal medicines are prepared from materials of herbal origin, which are often obtained from varied geographical and/or commercial sources. As a result it may not always be possible to ascertain the conditions to which they may have been subjected. In addition, they may vary in composition and properties. Furthermore, the procedures and techniques used in the manufacture and quality control of herbal medicines are often substantially different from those employed for conventional pharmaceutical products. Because of the inherent complexity of naturally grown medicinal plants and the often variable nature of cultivated ones, the examples of contamination with toxic medicinal plants and/or plant parts and the number and small quantity of defined active ingredients, the production and primary processing has a direct influence on the quality of herbal medicines. For this reason, application of GMPs in the manufacture of herbal medicines is an essential tool to assure their quality. 2. Scope This standard prescribes the product requirements, good manufacturing practices, requirements

for competence of personnel and testing of Ayush Products included in the API. /Unani Pharmacopoeia / Siddha Pharmacopoeia / Homeopathic Pharmacopoeia , Herbal Generics in approved books and Herbal P&P

3. Terminology

a) Ayush Products – products of ayurveda, unani, siddha and homeopathy systems of medicine that are covered under the Drugs and Cosmetics Act , Herbal Generics in approved books and Herbal P&P.

b) Acceptance criteria: Numerical limits, ranges, or other suitable measures for acceptance of the herbal substance, preparation and medicines based on the results of analytical procedures.


c) Authorized Person- A permanent full time employee of the organisation who has been trained and has defined responsibility to conduct the relevant / activity process.

d) Constituents with known therapeutic activity: are chemically defined substances or groups of substances which are generally accepted to contribute substantially to the therapeutic activity of a herbal substance, a herbal preparation or a herbal medicinal product.

e) Drug extract ratio (DER): means the ratio between the quantity of herbal substance used in the manufacture of a herbal preparation and the quantity of the herbal preparation obtained. The number (given as the actual range) written before the colon is the relative quantity of the herbal substance; the number written after the colon is the relative quantity of the herbal preparation obtained.

f) Extraction solvents: are solvents which are used for the extraction process. g) Genuine (Native) herbal preparation: refers to the preparation without excipients, even if

for technological reasons the genuine herbal preparation is not available. However, for soft and liquid herbal preparations the genuine herbal preparation may contain variable amounts of (extraction) solvent.

h) Ratio of herbal substance to genuine herbal preparation (DER genuine): is the ratio of the quantity of the herbal substance to the quantity of the resulting genuine herbal preparation. The number (given as the actual range) written before the colon is the relative quantity of the herbal substance; the number written after the colon is the relative quantity of the genuine herbal preparation obtained.

i) Herbal medicinal products: any medicinal product, exclusively containing as active substances one or more herbal substances or one or more herbal preparations, or one or more such herbal substances in combination with one or more such herbal preparations.

j) Herbal preparations: are obtained by subjecting herbal substances to treatments such as extraction, distillation, expression, fractionation, purification, concentration or fermentation. These include comminuted or powdered herbal substances, tinctures, extracts, essential oils, expressed juices and processed exudates.

k) Herbal substances: all mainly whole, fragmented or cut plants, plant parts, algae, fungi, lichen in an unprocessed, usually dried form but sometimes fresh. Certain exudates that have not been subjected to a specific treatment are also considered to be herbal substances. Herbal substances are precisely defined by the plant part used and the botanical name according to the binomial system (genus, species, variety).

l) Herbal teas: consist exclusively of one or more herbal substance(s) intended for oral aqueous preparations by means of decoction, infusion or maceration. The preparation is prepared immediately before use. Herbal teas are usually supplied in bulk form or in sachets.

m) Markers: are chemically defined constituents or groups of constituents of a herbal substance, a herbal preparation or a herbal medicinal product which are of interest for control purposes independent of whether they have any therapeutic activity. Markers serve to calculate the quantity of herbal substance(s) or herbal preparation(s) in the Herbal Medicinal Product if the marker has been quantitatively determined in the herbal substance or herbal preparations.

There are two categories of markers: • Active marker: are constituents or groups of constituents which are generally accepted

to contribute to the therapeutic activity. • Analytical marker: are constituents or groups of constituents that serve for analytical

purposes.


n) Quantification: means adjusting the herbal preparation to a defined range of constituents exclusively achieved by blending different batches of herbal substances and/or herbal preparations (e.g. quantified extracts).

o) Solvent: An inorganic or an organic liquid used for the preparation of solutions or suspensions in the manufacture of a herbal preparation or the manufacture of a herbal medicinal product.

p) Specification: A list of tests, references to analytical procedures, and appropriate acceptance criteria which are numerical limits, ranges, or other criteria for the tests described. It establishes the set of criteria to which a herbal preparation / herbal substance or herbal medicinal product should conform to be considered acceptable for its intended use. "Conformance to specifications" means that the herbal preparation / herbal substance and / or herbal medicinal product, when tested according to the listed analytical procedures, will meet the listed acceptance criteria. Specifications are binding quality standards that are agreed to between the appropriate governmental regulatory agency and the applicant.

q) Standardisation: means adjusting the herbal substance / herbal preparation to a defined content of a constituent or a group of constituents with known therapeutic activity respectively either by adding excipients or by blending batches of the herbal substance and/or herbal preparation (e.g. standardised extracts).

r) active ingredients -The herbal substance (s) or the herbal preparation(s) will be considered to be active ingredient(s) of a herbal medicine(s). However, if constituents with known therapeutic activities are known, the active ingredients should be standardized to contain a defined amount of this/these constituent(s).

s) blending -Blending is the process of combining materials or different batches to produce a homogeneous intermediate or finished product.

t) medicinal plant -Medicinal plants are plants (wild or cultivated) used for medicinal purposes.

u) medicinal plant materials – see herbal substances v) therapeutic activity - Therapeutic activity refers to the successful prevention, diagnosis and

treatment of physical and mental illnesses, improvement of symptoms of illnesses, as well as beneficial alteration or regulation of the physical and mental status of the body and development of a sense of general well-being.

4. Requirements 4.1 The Ayush products shall be processed from suitable quality raw materials as per method of

production and composition defined in the API/ UP/SP/HP 4.2 The raw materials used shall comply to requirements for raw materials specified in the

API/UP/SP/HP. 4.3 The finished Ayush products shall comply with

a) The requirements specified in API /UP/SP/HP. 4.4 Ayush products shall be processed, handled, packaged under hygienic conditions adhering to

the Good Manufacturing Practices detailed below; 4.4.1 Personal hygiene

a) All personnel, prior to and during employment, shall undergo health examinations at least once per year. Personnel conducting visual inspections shall also undergo periodic eye examinations.


b) All personnel shall be trained in the practices of personal hygiene. A high level of personal hygiene should be observed by all those concerned with manufacturing processes. In particular, personnel should be instructed to wash their hands before entering production areas. Signs to this effect should be posted and instructions observed.

c) Any person shown at any time to have an apparent illness or open lesions that may adversely affect the quality of products shall not be allowed to handle starting materials, packaging materials, in-process materials or drug products until the condition is no longer judged to be a risk.

d) All employees should be instructed and encouraged to report to their immediate supervisor any conditions (relating to plant, equipment or personnel) that they consider may adversely affect the products.

e) Direct contact shall be avoided between the operator’s hands and starting materials, primary packaging materials and intermediate or bulk product.

f) To ensure protection of the product from contamination, personnel shall wear clean body coverings appropriate to the duties they perform, including appropriate hair covering. Used clothes, if reusable, shall be stored in separate closed containers until properly laundered and, if necessary, disinfected or sterilized.

g) Smoking is not permitted on the premises ( except in designated areas ) . Eating, drinking, chewing, and keeping plants, food, drink, personal medicines, incense sticks, garlands etc shall not be permitted in production, laboratory and storage areas, or in any other areas where they might adversely influence product quality.

h) Personal hygiene procedures including the use of protective clothing shall apply to all persons entering production areas, whether they are temporary or full-time employees or non-employees, e.g. contractors’ employees, visitors, senior managers, and inspectors.

4.4.2 Premises a) Premises must be located, designed, constructed, adapted, and maintained to suit the

operations to be carried out. b) The layout and design of premises shall be such that it minimize the risk of errors and permit

effective cleaning and maintenance in order to avoid cross contamination, build-up of dust or dirt, and, in general, any adverse effect on the quality of products.

c) Where dust is generated (e.g. during sampling, weighing, mixing and processing operations, packaging of powder), measures shall be taken to avoid cross-contamination and facilitate cleaning.

d) Premises should be situated in an environment that, when considered together with measures to protect the manufacturing process, presents minimum risk of causing any contamination of materials or products.

e) Premises used for the manufacture of finished products shall be suitably designed and constructed to facilitate good sanitation.

f) Premises shall be carefully maintained, and it shall be ensured that repair and maintenance operations do not present any hazard to the quality of products.

g) Premises shall be cleaned and, where applicable, disinfected . h) Electrical supply, lighting, temperature, humidity and ventilation shall be appropriate and

such that they do not adversely affect, directly or indirectly, either the Ayush products during their manufacture and storage, or the accurate functioning of equipment.


i) Premises should be designed and equipped so as to afford maximum protection against the entry of insects, birds or other animals. There shall be a procedure for rodent and pest control.

j) Premises shall be designed to ensure the logical flow of materials and personnel. 4.4.2.1 Ancillary areas

a) Rest and refreshment rooms shall be separate from manufacturing and control areas. b) Facilities for changing and storing clothes and for washing and toilet purposes shall be easily

accessible and appropriate for the number of users. Toilets shall not communicate directly with production or storage areas and may preferably be separated from these areas.

c) Maintenance workshops should if possible be separated from production areas. Whenever parts and tools are stored in the production area, they should be kept in rooms or lockers reserved for that use.

d) Animal houses should be well isolated from other areas, with separate entrance (animal access) and air-handling facilities.

4.4.2.2 Storage areas a) Storage areas should be of sufficient capacity to allow orderly storage of the various

categories of materials and products with proper separation and segregation: starting and packaging materials, intermediates, bulk and finished products, products in quarantine, and released, rejected, returned or recalled products.

b) Storage areas should be designed or adapted to ensure good storage conditions. In particular, they shall be clean, dry, sufficiently lit and maintained within acceptable temperature limits. Where special storage conditions are required (e.g. temperature, humidity) these shall be provided, controlled, monitored and recorded where appropriate.

c) Receiving and dispatch bays shall be separated and materials and products be protected from the weather. Receiving areas shall be designed and equipped to allow containers of incoming materials to be cleaned if necessary before storage.

d) Where quarantine status is ensured by storage in separate areas, these areas shall be clearly marked and their access restricted to authorized personnel. Any system replacing the physical quarantine shall give equivalent security.

e) Segregation shall be provided for the storage of rejected, recalled, or returned materials or products.

f) Highly active and radioactive materials, narcotics, other dangerous drugs, and substances presenting special risks of abuse, fire or explosion should be stored in safe and secure areas.

g) Printed packaging materials are considered critical to the conformity of the pharmaceutical product to its labelling and special attention shall be paid to sampling and the safe and secure storage of these materials.

h) There should normally be a separate sampling area for starting materials. i) If sampling is performed in the storage area, it should be conducted in such a way as to

prevent contamination or cross-contamination. 4.4.2.3 Weighing areas

a) The weighing of starting materials and the estimation of yield by weighing shall be carried out in separate weighing areas designed for that use, for example with provisions for dust control. Such areas may be part of either storage or production areas.

4.4.2.4 Production areas


a) Premises should preferably be laid out in such a way as to allow the production to take place in areas connected in a logical order corresponding to the sequence of the operations and to the requisite cleanliness levels.

b) The adequacy of the working and in-process storage space shall permit the orderly and logical positioning of equipment and materials so as to minimize the risk of confusion between different Ayush products or their components, to avoid cross-contamination, and to minimize the risk of omission or wrong application of any of the manufacturing or control steps.

c) Where starting and primary packaging materials and intermediate or bulk products are exposed to the environment, interior surfaces (walls, floors and ceilings) shall be smooth and free from cracks and open joints, shall not shed particulate matter, and shall permit easy and effective cleaning and, if necessary, disinfection.

d) Pipework, light fittings, ventilation points and other services shall be designed and sited to avoid the creation of recesses that are difficult to clean. As far as possible, for maintenance purposes, they should be accessible from outside the manufacturing areas.

e) Drains should be of adequate size and designed and equipped to prevent back-flow. Open channels should be avoided where possible, but if they are necessary they shall be shallow to facilitate cleaning and disinfection.

f) Production areas shall be effectively ventilated, with air control facilities (including filtration of air to a sufficient level to prevent contamination and cross-contamination, as well as control of temperature and, where necessary, humidity) appropriate to the products handled, to the operations undertaken and to the external environment.

g) Premises for the packaging of Ayush products shall be specifically designed and laid out so as to avoid mix-ups or cross-contamination.

h) Production areas shall be well lit, particularly where visual on-line controls are carried out. 4.4.2.5 Quality control areas

a) The organisation shall have in-house testing facilities / Quality control laboratories and these shall be separated from production areas. Areas where biological, or microbiological test methods are employed shall be separated from each other and from other laboratories.

b) Quality control laboratories shall be designed to suit the operations to be carried out in them. Sufficient space shall be given to avoid mix-ups and cross-contamination of samples and reagents. There should be adequate suitable storage space for samples, reference standards (if necessary, with cooling), solvents, reagents and records.

c) The design of the laboratories should take into account the suitability of construction materials, prevention of fumes and ventilation. There shall be separate air supply to laboratories and production areas. Separate air-handling units and other provisions are needed for biological, and microbiological laboratories.

d) A separate room may be needed for instruments to protect them against electrical interference, vibration, contact with excessive moisture and other external factors, or where it is necessary to isolate the instruments.

4.4.3 Equipment a) Equipment must be located, designed, constructed, adapted, and maintained to suit the

operations to be carried out. The layout and design of equipment shall aim to minimize the risk of errors and permit effective cleaning and maintenance in order to avoid cross-contamination, build-up of dust or dirt, and, in general, any adverse effect on the quality of products.


b) Equipment shall be installed, cleaned, maintained and operated in such a way as to minimize any risk of error or of contamination.

c) Fixed pipework should be clearly labelled to indicate the contents and, where applicable, the direction of flow.

d) All service piping and devices should be adequately marked and special attention paid to the provision of non-interchangeable connections or adaptors for dangerous gases and liquids.

e) Balances and other measuring equipment of an appropriate range and precision should be available for production and control operations and should be calibrated on a scheduled basis.

f) Production equipment should be thoroughly cleaned on a scheduled basis. g) Laboratory equipment and instruments shall be suited to the testing procedures undertaken. h) Washing, cleaning and drying equipment should be chosen and used so as not to be a

source of contamination. i) Production equipment should not present any hazard to the products. The parts of the

production equipment that come into contact with the product shall not be reactive, additive, or absorptive to an extent that would affect the quality of the product. Justification that equipment will not contaminate the product shall be provided by the manufacturer. Non-wooden equipment should be used unless tradition demands wooden material. Where it is necessary to use traditional equipment (such as wooden implements, clay pots, pallets, hoppers, etc.), this should be dedicated, unless otherwise justified. When such equipment is used, it is advisable that it does not come into direct contact with chemicals or contaminated material. If the use of wooden equipment is unavoidable, special consideration must be given to its cleaning as wooden materials may retain odours, be easily discoloured and are easily contaminated.

j) Defective equipment shall be removed from production and quality control areas. If this is not possible, it shall be clearly labelled as defective to prevent use.

k) Closed equipment should be used whenever appropriate. Where open equipment is used or equipment is opened, precautions shall be taken to minimize contamination.

l) Non-dedicated equipment shall be cleaned according to validated cleaning procedures between production of different pharmaceutical products to prevent cross-contamination.

m) Vacuum or wet-cleaning methods are preferred. If wet-cleaning is done, the equipment should be dried immediately after cleaning to prevent the growth of microorganisms. Cleaning with compressed air and brushes should be used with care and avoided if possible, as these methods increase the risk of product contamination.

n) Current drawings of critical equipment and support systems should be maintained 4.4.4 Materials

a) No materials used for operations such as cleaning, lubrication of equipment and pest control, should come into direct contact with the starting material, packing material, work in process or finished product. Where possible, such materials should be of a suitable grade (e.g. food grade) to minimize health risks.

b) All incoming materials and finished products should be quarantined immediately after receipt or processing, until they are released for use or distribution.

c) All materials and products should be stored under the appropriate conditions established by the manufacturer and in an orderly fashion to permit batch segregation and stock rotation by a first-in, first-out rule.


d) Water used in the manufacture of pharmaceutical products shall comply with WHO guidelines for drinking (potable) water quality.

4.4.4.1 Starting materials a) Starting materials should be purchased only from approved suppliers and, where possible,

directly from the producer. The specifications established by the manufacturer for the starting materials should be discussed with the supplier All incoming materials should be checked to ensure that the consignment corresponds to the order. Containers should be cleaned where necessary and labelled, if required, with the prescribed information. Where additional labels are attached to containers, the original information should not be lost.

b) Damage to containers and any other problem that might adversely affect the quality of a material should be recorded and reported to the quality control department and investigated.

c) If one delivery of material is made up of different batches, each batch must be considered as separate for sampling, testing and release.

d) Starting materials in the storage area should be appropriately labelled. e) Only starting materials released by the quality control department and within their shelf-life

shall be used. Reference to WHO guidelines on stability studies for herbal materials or herbal preparations should be made.

f) Materials dispensed for each batch of the final product shall be kept together and conspicuously labelled as such.

4.4.4.2 Labels shall bear at least the following information: a) the designated name of the product and the internal code reference where applicable; b) the batch number given by the supplier and, on receipt, the control or batch number given by

the manufacturer, if any, documented so as to ensure traceability; c) the status of the contents (e.g. in quarantine, on test, released, rejected, returned, recalled); d) where appropriate, an expiry date or a date beyond which retesting is necessary. e) analytical Report no. on label of approved material f) no. of container upon total no. of containers.

4.4.4.3 Packaging materials a) The purchase, handling and control of primary and printed packaging materials should be as

for starting materials. b) Printed packaging materials shall be stored in secure conditions so as to exclude the

possibility of unauthorized access. Roll-feed labels should be used wherever possible. Cut labels and other loose printed materials should be stored and transported in separate closed containers so as to avoid mix-ups. Packaging materials should be issued for use only by designated personnel following an approved and documented procedure.

c) Each delivery or batch of printed or primary packaging material shall be given a specific reference number or identification mark.

d) Outdated or obsolete primary packaging material or printed packaging material shall be destroyed and its disposal recorded.

e) All products and packaging materials to be used shall be checked on delivery to the packaging department for quantity, identity and conformity with the packaging instructions.

4.4.4.4 Intermediate and bulk products a) Intermediate and bulk products should be kept under appropriate conditions. b) Intermediate and bulk products purchased as such shall be handled on receipt as though

they were starting materials. 4.4.4.5 Finished products


a) Finished products should be held in quarantine until their final release, after which they should be stored as usable stock under conditions established by the manufacturer.

4.4.4.6 Rejected, recovered, reprocessed and reworked materials a) Rejected materials and products should be clearly marked as such and stored separately in

restricted areas. They should either be returned to the suppliers or, where appropriate, reprocessed or destroyed in a timely manner.

b) Whatever action is taken should be approved by authorized personnel and recorded. c) The reworking or recovery of rejected products should be exceptional. It is permitted only if

the quality of the final product is not affected, if the specifications are met, and if it is done in accordance with a defined and authorized procedure after evaluation of the risks involved. A record shall be kept of the reworking or recovery. A reworked batch shall be given a new batch number.

d) The introduction of all or part of earlier batches, conforming to the required quality, into a batch of the same product at a defined stage of manufacture shall be authorized beforehand. This recovery shall be carried out after evaluation of the risks involved, including any possible effect on shelf-life. The recovery shall be recorded.

e) Any finished product that has been reprocessed reworked or into which a recovered product has been incorporated, shall be retested for all requirements.

4.4.4.7 Recalled products a) Recalled products shall be identified and stored separately in a secure area until a decision

is taken on their fate. The decision should be made as soon as possible. 4.4.4.8 Returned goods

a) Products returned from the market shall be destroyed unless it is certain that their quality is satisfactory; in such cases they may be considered for resale or relabeling, or alternative action taken only after they have been critically assessed .The nature of the product, any special storage conditions it requires, its condition and history, and the time elapsed since it was issued should all be taken into account in this assessment. Where any doubt arises over the quality of the product, it shall not be considered suitable for reissue or reuse. Any action taken should be appropriately recorded.

4.4.4.9 Waste materials a) Toxic substances and flammable materials shall be stored in suitably designed, separate,

enclosures, as required by national legislation. b) Waste material shall not be allowed to accumulate. It should be collected in suitable

receptacles for removal to collection points outside the buildings and disposed of safely and in a sanitary manner at regular and frequent intervals. Waste material shall be disposed as required by national legislation.

4.4.4.10 Miscellaneous a) Rodenticides, insecticides, fumigating agents and sanitizing materials shall not be permitted

to contaminate equipment, starting materials, packaging materials, in-process materials or finished products.

4.4.4.11 Reference samples and standards - The reference standard for a herbal medicine may be a botanical sample of the herbal material; a sample of the herbal preparation, e.g. extract; or a chemically defined substance, e.g. a known active constituent, a marker substance or a known impurity. The reference standard should be of a quality appropriate to its purpose. If the herbal medicine is not described in a recognized pharmacopoeia, a herbarium sample of the flowering or fruiting top of the whole medicinal plant or part of the medicinal plant (e.g. if the whole


medicinal plant is a tree) should be available. All reference standards should be stored under appropriate conditions to prevent degradation. Their expiry and/or revalidation date should be determined and indicated.

4.4.5 Documentation a) Documents should be approved, signed and dated by the appropriate responsible persons.

No document should be changed without authorization and approval. b) Documents should have unambiguous contents: the title, nature and purpose should be

clearly stated. Reproduced documents should be clear and legible. c) Documents should be regularly reviewed and kept up to date. When a document has been

revised, a system should exist to prevent inadvertent use of the superseded version. Superseded documents should be retained for a specific period of time.

d) Records should be made or completed when any action is taken and in such a way that all significant activities concerning the manufacture of the Ayush products are traceable. Records should be retained for at least one year after the expiry date of the finished product.

4.4.5.1 Labels a) Labels applied to containers, equipment or premises should be clear, unambiguous and in

the company’s agreed format. b) For reference standards, the label and/or accompanying document should indicate potency

or concentration, date of manufacture, expiry date, date the closure is first opened, storage conditions and control number, as appropriate.

4.4.5.2 Packaging instructions a) Packaging instructions for each product, pack size and type shall be defined. These should

include, or make reference to: i. the name of the product; ii. a description of its pharmaceutical form, strength and directions for use; iii. the pack size expressed in terms of the number, weight or volume of the product in the

final container; iv. a complete list of all the packaging materials required for a standard batch size, including

quantities, sizes and types, with the code or reference number relating to the specifications for each packaging material;

v. where appropriate, an example or reproduction of the relevant printed packaging materials and specimens, indicating where the batch number and expiry date of the product have been marked;

vi. special precautions to be observed, including a careful examination of the packaging area and equipment in order to ascertain the line clearance before and after packaging operations;

vii. a description of the packaging operation, including any significant subsidiary operations, and equipment to be used;

viii. details of in-process controls with instructions for sampling and acceptance limits. 4.4.5.3 Batch processing records

a) A batch processing record shall be kept for each batch processed. It shall be based on the relevant parts of the currently approved specifications on the record.

b) Before any processing begins, a check should be made that the equipment and work station are clear of previous products, documents, or materials not required for the planned process, and that the equipment is clean and suitable for use. This check should be recorded.


c) During processing, the following information shall be recorded at the time each action is taken, and after completion the record shall be dated and signed by the person responsible for the processing operations:

i. the name of the product; ii. the number of the batch being manufactured; iii. dates and times of commencement, of significant intermediate stages, and of completion

of production; iv. the name of the person responsible for each stage of production; v. the initials of the operator(s) of different significant steps of production and, where

appropriate, of the person(s) who checked each of these operations (e.g. weighing); vi. the batch number and/or analytical control number and the quantity of each starting

material actually weighed (including the batch number and amount of any recovered or reprocessed material added);

vii. any relevant processing operation or event and the major equipment used; viii. the in-process controls performed, the initials of the person(s) carrying them out, and the

results obtained; ix. the amount of product obtained at different and pertinent stages of manufacture (yield),

together with comments or explanations for significant deviations from the expected yield;

x. notes on special problems including details, with signed authorization for any deviation from the master formula.

4.4.5.4 Batch packaging records a) A batch packaging record shall be kept for each batch or part batch processed. b) Before any packaging operation begins, checks should be made that the equipment and

work station are clear of previous products, documents or materials not required for the planned packaging operations, and that equipment is clean and suitable for use. These checks should be recorded.

c) The following information shall be recorded at the time each action is taken, and the date and the person responsible should be clearly identified by signature or electronic password:

i. the name of the product, the batch number and the quantity of bulk product to be packed, as well as the batch number and the planned quantity of finished product that will be obtained, the quantity actually obtained and the reconciliation;

ii. the date(s) and time(s) of the packaging operations; iii. the name of the responsible person carrying out the packaging operation; iv. the initials of the operators of the different significant steps; v. the checks made for identity and conformity with the packaging instructions, including the

results of in-process controls; vi. details of the packaging operations carried out, including references to equipment and

the packaging lines used, and, when necessary, the instructions for keeping the product unpacked or a record of returning product that has not been packaged to the storage area;

vii. whenever possible, samples of the printed packaging materials used, including specimens bearing the approval for the printing of and regular check (where appropriate) of the batch number, expiry date, and any additional overprinting;

viii. notes on any special problems, including details of any deviation from the packaging instructions, with written authorization by an appropriate person;


ix. the quantities and reference number or identification of all printed packaging materials and bulk product issued, used, destroyed or returned to stock and the quantities of product obtained to permit an adequate reconciliation.

4.4.5.5 Standard operating procedures (SOPs) and records a) Standard operating procedures and associated records of actions taken or, where

appropriate, conclusions reached should be available for: i. equipment assembly and validation; ii. analytical apparatus and calibration; iii. maintenance, cleaning and sanitization; iv. personnel matters including qualification, training, clothing and v. hygiene; vi. environmental monitoring; vii. pest control; viii. complaints; ix. recalls; x. returns. xi. reprocessing of a batch xii. handling of hazardous materials like cleaning liquids, pesticides, disinfectants, gases,

flammable materials, solvents etc xiii. entry into and exit from production areas xiv. preparation, handling, using and standardization and frequency of retesting of reagents xv. handling of materials with out of specification results of analysis

b) There should be standard operating procedures and records for the receipt of each delivery

of starting material and primary and printed packaging material. c) The records of the receipts should include:

i. the name of the material on the delivery note and the containers; ii. the “in-house” name and/or code of material if different from (a); iii. the date of receipt; iv. the supplier’s name and, if possible, manufacturer’s name; v. the manufacturer’s batch or reference number; vi. the total quantity, and number of containers received; vii. the batch number assigned after receipt; viii. any relevant comment (e.g. state of the containers).

d) There should be standard operating procedures for the internal labelling, quarantine and storage of starting materials, packaging materials and other materials, as appropriate.

e) Standard operating procedures should be available for each instrument and piece of equipment (e.g. use, calibration, cleaning, maintenance) and placed in close proximity to the equipment.

f) There should be standard operating procedures for sampling, which specify the person(s) authorized to take samples.

g) The sampling instructions should include: i. the method of sampling and the sampling plan; ii. the equipment to be used; iii. any precautions to be observed to avoid contamination of the material or any

deterioration in its quality;


iv. the amount(s) of sample(s) to be taken; v. instructions for any required subdivision of the sample; vi. the type of sample container(s) to be used, and whether they are for aseptic sampling or

for normal sampling, and labelling; vii. any specific precautions to be observed, especially in regard to the sampling of sterile or

noxious material. h) There shall be a standard operating procedure describing the details of the unique batch (lot)

numbering system, with the objective of ensuring that each batch of intermediate, bulk or finished product is identified with a specific batch number. The batch numbering applied to the processing stage and to the respective packaging stage should be related to each other.

i) Batch-number allocation shall be recorded, with details of at least the date of allocation, product identity and size of batch.

j) There should be written procedures for testing materials and products at different stages of manufacture, describing the methods and equipment to be used. The tests performed should be recorded.

k) Analysis records shall include at least the following data: i. the name of the material or product and, where applicable, dosage form; ii. the batch number and, where appropriate, the manufacturer and/or supplier; iii. references to the relevant specifications and testing procedures; iv. test results, including observations and calculations, and reference to any specifications

(limits); v. date(s) and reference number(s) of testing; vi. the initials of the persons who performed the testing; vii. the date and initials of the persons who verified the testing and the calculations, where

appropriate; viii. a clear statement of release or rejection (or other status decision) and the dated

signature of the designated responsible person. l) Written release and rejection procedures should be available for materials and products, and

in particular for the release for sale of the finished product by an authorized person. m) Records shall be maintained of the distribution of each batch of a product in order, e.g. to

facilitate the recall of the batch if necessary. n) Records shall be kept for major and critical equipment, as appropriate, of any validations,

calibrations, maintenance, cleaning, or repair operations, including dates and the identity of the people who carried these operations out.

o) The use of all equipment and the areas where products have been processed should be appropriately recorded in chronological order.

p) There shall be written procedures assigning responsibility for cleaning and sanitation and describing in sufficient detail the cleaning schedules, methods, equipment and materials to be used and facilities and equipment to be cleaned, and these shall be followed.

4.4.6 Good practices in production a) All handling of materials and products, such as receipt and cleaning, quarantine, sampling,

storage, labelling, dispensing, processing, packaging and distribution shall be carried out under good hygienic and good manufacturing practices.

b) Checks on yields and reconciliation of quantities shall be carried out as necessary to ensure that there are no discrepancies outside acceptable limits.


c) Operations on different products shall not be carried out simultaneously or consecutively in the same room or area unless there is no risk of mix-up or cross-contamination.

d) At all times during processing, all materials, bulk containers, major items of equipment, and where appropriate, the rooms and packaging lines being used should be labelled or otherwise identified with an indication of the product or material being processed, its strength (where applicable) and the batch number.

e) Access to production premises shall be restricted to authorized personnel. 4.4.6.1 Prevention of cross-contamination and bacterial contamination during production

a) When dry materials and products are used in production, special precautions shall be taken to prevent the generation and dissemination of dust. Provision shall be made for proper air control (e.g. supply and extraction of air of suitable quality).

b) Contamination of a starting material or of a product by another material or product shall be avoided. This risk of accidental cross-contamination arises from the uncontrolled release of dust, gases, particles, vapours, sprays or organisms from materials and products in process, from residues on equipment, from intruding insects, and from operators’ clothing, skin, etc.

c) Cross-contamination should be avoided by taking appropriate technical or organizational measures, for example:

i. carrying out production in dedicated and self-contained areas , ii. conducting campaign production (separation in time) followed by appropriate cleaning in

accordance with a validated cleaning procedure; iii. providing appropriately designed airlocks, pressure differentials, and air supply and

extraction systems; iv. minimizing the risk of contamination caused by recirculation or re-entry of untreated or

insufficiently treated air; v. wearing protective clothing where products or materials are handled; vi. using cleaning and decontamination procedures of known effectiveness; vii. using a “closed system” in production; viii. testing for residues; ix. using cleanliness status labels on equipment.

d) Measures to prevent cross-contamination and their effectiveness should be checked periodically according to standard operating procedures.

e) Production areas where susceptible products are processed should undergo periodic environmental monitoring (e.g. for microbiological monitoring and particulate matter where appropriate).

4.4.6.2 Processing operations a) Before any processing operation is started, steps shall be taken to ensure that the work area

and equipment are clean and free from any starting materials, products, product residues, labels or documents not required for the current operation.

b) Defective equipment shall be withdrawn from use and appropriately labelled and preferably covered until the defect has been rectified. After use, production equipment shall be cleaned without delay according to detailed written procedures and stored under clean and dry conditions in a separate area or in a manner that will prevent contamination.

c) Time limits for storage of equipment after cleaning and before use should be stated, be based on data and scheduled by the manufacturer.. Containers for filling shall be cleaned before filling. Attention should be given to avoiding and removing any contaminants such as glass fragments and metal particles.


d) Any significant deviation from the expected yield should be recorded and investigated. e) Measuring, weighing, recording, and control equipment and instruments shall be serviced

and calibrated at prespecified intervals and records maintained. To ensure satisfactory functioning, instruments should be checked at appropriate intervals or prior to use for performing analytical tests. The date of calibration and servicing and the date when recalibration is due shall be clearly indicated,preferably on a label attached to the instrument.

f) Repair and maintenance operations should not present any hazard to the quality of the products.

4.4.6.3 Packaging operations a) Different products shall not be packaged in close proximity unless there is physical

segregation or an alternative system that will provide equal assurance. b) Before packaging operations are begun, steps shall be taken to ensure that the work area,

packaging lines, printing machines and other equipment are clean and free from any products, materials or documents used previously and which are not required for the current operation.

c) The name and batch number of the product being handled shall be displayed at each packaging station or line.

d) Normally, filling and sealing shall be followed as quickly as possible by labelling. If labelling is delayed, appropriate procedures should be applied to ensure that no mix-ups or mislabelling can occur.

e) The correct performance of any printing (e.g. of code numbers or expiry dates) done separately or in the course of the packaging shall be checked and recorded. Printing by hand, should be rechecked at regular intervals.

f) Special care should be taken when cut labels are used and when overprinting is carried out off-line, and in hand-packaging operations. Roll-feed labels are normally preferable to cut labels in helping to avoid mix-ups. On-line verification of all labels by automated electronic means can be helpful in preventing mix-ups, but checks should be made to ensure that any electronic code readers, label counters, or similar devices are operating correctly. When labels are attached manually, in-process control checks should be performed more frequently.

g) Printed and embossed information on packaging materials should be distinct and resistant to fading or erasing.

h) Regular on-line control of the product during packaging shall include at least checks on: i. the general appearance of the packages; ii. whether the packages are complete; iii. whether the correct products and packaging materials are used; iv. whether any overprinting is correct; v. the correct functioning of line monitors.

i) Samples taken away from the packaging line shall not be returned. j) Products that have been involved in an unusual event during packaging shall be

reintroduced into the process only after special inspection, investigation and approval by authorized personnel. A detailed record shall be kept of this operation.

k) Any significant or unusual discrepancy observed during reconciliation of the amount of bulk product and printed packaging materials and the number of units produced shall be investigated, satisfactorily accounted for, and recorded before release.


l) Upon completion of a packaging operation, any unused batch-coded packaging materials shall be destroyed and the destruction recorded. A documented procedure requiring checks to be performed before returning unused materials should be followed if uncoded printed materials are returned to stock.

4.4.7 Good practices in quality control a) Quality control is concerned with sampling, specifications and testing, and with the

organization, documentation and release procedures which ensure that the necessary and relevant tests are actually carried out and that materials are not released for use, nor products released for sale or supply, until their quality has been judged to be satisfactory.

b) The quality control function should have adequate resources available so as to ensure that all the quality control arrangements are effectively and reliably carried out., which includes;

i. sampling of starting materials, packaging materials, intermediate products, bulk products and finished products by approved methods ;

ii. performance of qualification and validation ; iii. recording for demonstrating that all the required sampling, inspecting and testing

procedures have actually been carried out and that any deviations have been fully recorded and investigated;

iv. the finished products must contain ingredients complying with the qualitative and quantitative composition of the product described in the relevant regulatory requirements; the ingredients shall be of the required purity, in their proper container and correctly labelled;

v. records shall be made of the results of inspecting and testing the materials and intermediate, bulk and finished products against specifications; product assessment must include a review and evaluation of the relevant production documentation and an assessment of deviations from specified procedures;

vi. no batch of product is to be released for sale or supply prior to certification by the authorized person(s) that it is in accordance with the requirements of the relevant regulatory requirement.

vii. sufficient samples of starting materials and products shall be retained to permit future examination of the product if necessary; the retained product shall be kept in its final pack unless the pack is exceptionally large.

c) Assessment of finished products includes checking the production conditions, the results of in-process testing, the manufacturing (including packaging) documentation, compliance with the specification for the finished product, and an examination of the finished pack.

4.4.7.1 Control of starting materials and intermediate, bulk and finished products a) All tests shall follow the instructions given in the relevant written test procedure for each

material or product as specified in the API or he importing country Regulation. The result should be checked by the supervisor before the material or product is released or rejected.

b) Samples shall be representative of the batches of material from which they are taken in accordance with the approved written procedure.

c) Sampling shall be carried out so as to avoid contamination or other adverse effects on quality. The containers that have been sampled should be marked accordingly and carefully resealed after sampling. Samples drawn for checking/testing shall not be released for sale.

d) Sampling equipment shall be cleaned and, if necessary, sterilized before and after each use and stored separately from other laboratory equipment.

e) Each sample container should bear a label indicating:


i. the name of the sampled material; ii. the batch or lot number; iii. the number of the container from which the sample has been taken; iv. the number of the sample; v. the signature of the person who has taken the sample; vi. the date of sampling.

f) Out-of-specification results obtained during testing of materials or products shall be investigated in accordance with an approved procedure. Records should be maintained.

4.4.7.2 Test requirements - Starting and packaging materials a) Before releasing a starting or packaging material for use, they shall be tested for conformity

with specifications for identity, strength, purity and other quality parameters. b) In lieu of testing by the manufacturer, a certificate of analysis may be accepted from the

supplier, provided that the manufacturer establishes the reliability of the supplier’s analysis through appropriate periodic validation of the supplier’s test results and through on-site audits of the supplier’s capabilities.

4.4.7.3 Test requirements - In-process control a) In-process control records should be maintained and form a part of the batch records.

4.4.7.4 Test requirements - Finished products a) For each batch of Ayush product, there shall be an appropriate laboratory determination of

satisfactory conformity to its finished product specification prior to release. b) Products failing to meet the established specifications or any other relevant quality criteria

shall be rejected. 4.4.7.5 Batch record review

a) Production and quality control records shall be reviewed as part of the approval process of batch release. Any divergence or failure of a batch to meet its specifications shall be thoroughly investigated. The investigation should, if necessary, extend to other batches of the same product and other products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and should include the conclusion and follow-up action.

b) Retention samples from each batch of finished product shall be kept for at least one year after the expiry date. Finished products should usually be kept in their final packaging and stored under the recommended conditions. Samples of active starting materials shall be retained for at least one year beyond the expiry date of the corresponding finished product. Other starting materials (other than solvents, gases, and water) shall be retained for a minimum of two years if their stability allows. Retention samples of materials and products should be of a size sufficient to permit at least two full re-examinations.

4.4.7.6 Stability studies a) The quality and stability of finished Ayush products and, when necessary, of starting

materials and intermediate products shall be evaluated. b) Expiry dates and shelf-life specifications shall be established on the basis of stability tests

related to storage conditions. c) A written programme for ongoing stability determination should be developed and

implemented to include elements such as: i. a complete description of the Ayush product involved in the study;


ii. the complete set of testing parameters and methods, describing all tests for potency, purity, and physical characteristics and documented evidence that these tests indicate stability;

iii. provision for the inclusion of a sufficient number of batches; iv. the testing schedule for each Ayush product; v. provision for special storage conditions; vi. provision for adequate sample retention; vii. a summary of all the data generated, including the evaluation and the conclusions of the

study. d) Stability should be determined prior to marketing and following any significant changes in

processes, equipment, packaging materials, etc. 4.4.8 Qualification and validation

a) The company should identify what qualification and validation work is required to prove that the critical aspects of their particular operation are controlled.

b) The key elements of a qualification and validation programme of a company should be clearly defined and documented in a validation master plan.

c) Qualification and validation should establish and provide documentary evidence that: i. the premises, supporting utilities, equipment and processes have been designed in

accordance with the requirements for GMP ; ii. the premises, supporting utilities and equipment have been built and installed in

compliance with their design specifications ; iii. the premises, supporting utilities and equipment operate in accordance with their design

specifications ; iv. a specific process will consistently produce a product meeting its predetermined

specifications and quality attributes. d) Any aspect of operation, including significant changes to the premises, facilities, equipment

or processes, which may affect the quality of the product, directly or indirectly, should be qualified and validated.

e) The ongoing programme should follow their first implementation and should be based on an annual review. On review any changes to the initial programme to be justified.

f) The responsibility of performing validation should be clearly defined. g) Validation studies should be conducted in accordance with predefined and approved

protocols. h) A written report summarizing the results recorded and the conclusions reached should be

prepared and stored. i) Processes and procedures should be established on the basis of the results of the validation

performed. 4.4.9. Complaints

a) All complaints including those of adverse side effects and other information concerning potentially defective products should be carefully reviewed according to written procedures and the corrective action should be taken.

b) The person responsible for handling complaints and deciding on the measures to be taken to deal with them shall have appropriate training and/or experience in the specific features of the quality control of herbal medicines.

c) There should be written procedures describing the action to be taken, including the need to consider a recall, in the case of a complaint concerning a possible product defect.


d) Any complaint concerning a product defect shall be recorded with all the original details and thoroughly investigated. The person responsible for quality control shall be involved in the review of such investigations.

e) If a product defect is discovered or suspected in a batch, other batches that may contain reprocessed product from the defective batch should also be investigated.

f) Where necessary, appropriate follow-up action, possibly including product recall, should be taken after investigation and evaluation of the complaint.

g) All decisions made and measures taken as a result of a complaint shall be recorded and referenced to the corresponding batch records.

h) Complaints records shall be regularly reviewed for any indication of specific or recurring problems that require attention and might justify the recall of marketed products.

i) The competent authorities should be informed if a manufacturer is considering action following possibly faulty manufacture, product deterioration, counterfeiting or any other serious quality problems with a product.

4.4.10 Product recalls a) There should be a system to recall from the market, promptly and effectively, products known

or suspected to be defective. b) The authorized person should be responsible for the execution and coordination of recalls. c) There should be established written procedures, which are regularly reviewed and updated,

for the organization of any recall activity. Recall operations should be capable of being initiated promptly down to the required level in the distribution chain.

d) Recalled products shall be stored in a secure segregated area while their fate is decided. e) All customers / competent authorities of all countries to which a given product has been

distributed should be promptly informed of any intention to recall the product because it is, or is suspected of being, defective.

f) The distribution records should be readily available to the authorized person, and they should contain sufficient information on wholesalers and directly supplied customers (including, for exported products, those who have received samples for clinical tests and medical samples) to permit an effective recall.

g) The progress of the recall process should be monitored and recorded. h) Records should include the disposition of the product. A final report should be issued,

including a reconciliation between the delivered and recovered quantities of the products. i) The effectiveness of the arrangements for recalls should be tested and evaluated from time

to time. 4.4.11 Personnel

w) The organization structure and the responsibilities and authorities of personnel shall be defined. The manufacturer shall have adequate number of personnel with the necessary qualifications and practical experience. Individual responsibilities and authorities should be clearly defined and understood by the persons concerned and recorded as written descriptions.

x) There should be no gaps or unexplained overlaps in the responsibilities of personnel concerned with the application of GMP.

y) All personnel should be aware of the principles of GMP that affect them and receive initial and continuing training, including hygiene instructions, relevant to their needs.

z) Key personnel responsible for supervising the manufacture and quality control of Ayush products shall possess the qualifications of (a) an expert in Ayurveda /Unani /Siddha


/Homeopathy (b) Chemist who shall possess at least a Bachelor’s Degree in Science,Pharmacy or Pharmacy (Ayurveda/ siddha/ unani/ homeopathy ) (c) Botanist who shall possess atleast a Bachelor’s degree in Science(Medicine ) or Pharmacy or Pharmacy (Ayurveda / siddha / unani / Homeopathy,and adequate practical experience as required by national legislation in the Drugs and Cosmetics Act .

aa) The release of herbal medicines shall be authorized by a person ( Known As Responsible Person ) who has been trained in the specific features of processing and quality control of herbal substances, herbal preparations and finished herbal products.

bb) Personnel dealing with the production and quality control of herbal medicines shall have adequate training in the specific issues relevant to herbal medicines.

4.4.12 Training a) The personnel should have adequate training in appropriate fields such as pharmaceutical

technology, taxonomic botany, phytochemistry, pharmacognosy, hygiene, microbiology and related subjects (such as traditional use of herbal medicines).

b) Training records should be maintained and periodic assessments of the effectiveness of training programmes should be made.

5. Packing - The products shall be packed in clean, hygienic .bottles / containers / made of materials

suitable for the respective dosage form and confirmed with suitable stability studies as per regulations .

6. Labelling - The Ayush products shall be marked legibly on the label of the bottle / package …;

a) Name of the Ayush Product; b) List of active Ingredients , showing the amount of each present and a statement of the net

contents (e.g. number of dosage units, weight, volume); c) Dosage form d) Batch number assigned by the manufacturer; e) the expiry date in an uncoded form; f) any special storage conditions or handling precautions that may be necessary; g) directions for use, and warnings and precautions that may be necessary; h) the name and address of the manufacturer or the company or the person responsible for

placing the product on the market. i) Any others as required by the Regulation

7. References API UNANI PH SIDDHA PH HOMEOPATHIC PH Indian Pharma WHO guidelines

Section III Annex B Version 1 Page 1 of 1

Annex B



Permissible Levels of Contaminants for AYUSH Premium Mark

1. Heavy Metals

S. No. Parameters Permissible Limit 1 Lead (Pb) 10 ppm 2 Cadmium (Cd) 0.3 ppm 3 Arsenic (As) 3 ppm 4 Mercury (Hg) 1 ppm Note – These are based on Department of Ayurveda, Yoga & Naturopahy, Unani, Siddha, and Homeopathy Order No. .F.No.K -11020/5/97- DCC (AYUSH ) dated 14 Oct 2005. 2. Aflatoxins

S. No. Parameters Permissible Limit 1 B 1 5.0 ppb 2 B1+ G1 + B2 + G2 sum of 10 ppb 3. Pesticide Residues

These shall be as per API / UPI / SPI / HPI / /Importing country regulations.

4. Microbial contamination These shall be as per API/UPI/SP/HPI//Importing country regulations.

Section III Annex C Version 1 Page 1 of 2

Annex C



Permissible Levels of Contaminants for AYUSH Standard Mark

1. Heavy Metals

S.No. Parameters Permissible limit 1. Lead ( Pb ) 10 ppm 2 Cadmium ( Cd ) 0.3 ppm 3. Arsenic ( As ) 3 ppm 4. Mercury ( Hg ) 1 ppm

2. Aflatoxins

S.No Aflatoxins Permissible Limit

1. B1 0.5 ppm 2. G1 0.5 ppm 3. B2 0.1 ppm 4. G2 0.1 ppm

3. Pesticide Residues

Substance Limit (mg/kg) Alachlor 0.02 Aldrin and Dieldrin (sum of ) 0.05 Azinphos-methyl 1.0 Bromopropylate 3.0 Chlordane (sum of cis-, trans - and Oxythlordane) 0.05 Chlorfenvinphos 0.5 Chlorpyrifos 0.2 Chlorpyrifos-methyl 0.1 Cypermethrin (and isomers) 1.0 DDT (sum of p,p-'DDT, o,p-'DDT, p,p-'DDE and p,p-'TDE 1.0 Deltamethrin 0.5

Section III Annex C Version 1 Page 2 of 2

Diazinon 0.5 Dichlorvos 1.0 Dithiocarbamates (as CS2) 2.0 Endosulfan (sum of isomers and Endosulfan sulphate) 3.0 Endrin 0.05 Ethion 2.0 Fenitrothion 0.5 Fenvalerate 1.5 Fonofos 0.05 Heptachlor (sum of Heptachlor and Heptachlorepoxide) 0.05 Hexachlorobenzene 0.1 Hexachlorocyclohexane isomers (other than γ) 0.3 Lindane (γ-Hexachlorocyclohexane) 0.6 Malathion 1.0 Methidathion 0.2 Parathion 0.5 Parathion-methyl 0.2 Permethrin 1.0 Phosalone 0.1 Piperonyl butoxide 3.0 Pirimiphos-methyl 4.0 Pyrethrins (sum of) 3.0 Quintozene (sum of quintozene, pentachloroaniline and 1.0 methyl pentachlorophenyl sulphide)

4. Microbial Contamination S.No. Parameters Permissible limits 1. Staphylococcus aureus/g. Absent

2. Salmonella sp./g . Absent 3. Pseudomonas aeruginosa/g Absent 4. Escherichia coli Absent 5. Total microbial plate count (TPC) 105/g*

6. Total Yeast & Mould 103/g *For topical use, the limit shall be 107/g.

Section IV Annex A Version 1 Page 1 of 6

Annex A

VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS Section IV

INTERNAL QUALITY ASSURANCE PROTOCOL

Internal Quality Assurance Protocol

1. This document describes the controls over process and the product at various stages of production, and the hygienic conditions for ensuring the consistent production of Ayush products meeting the specified certification criteria. T

2. An Inspection and Test plan has been documented defining the controls over the incoming herbal starting material, in process controls and the final Ayush product.

3. Batch – For the purpose of this Internal Quality Assurance Protocol for Ayush Products, a batch (or lot) is a defined quantity of starting material, packaging material, or product processed in a single process or series of processes so that it is expected to be homogeneous. It may sometimes be necessary to divide a batch into a number of sub-batches, which are later brought together to form a final homogeneous batch. In the case of terminal sterilization, the batch size is determined by the capacity of the autoclave. In continuous manufacture, the batch must correspond to a defined fraction of the production, characterized by its intended homogeneity. The batch size can be defined either as a fixed quantity or as the amount produced in a fixed time interval.

4. The manufacturer shall test the products in the laboratory, which shall be suitably equipped and staffed. The inspection and testing shall be shall be carried out in accordance with the methods given in the relevant Pharmacopeia API/UPI /SPI/HPI/Internationally recognized methods / the relevant Regulation of the importing country. Records of all tests performed shall be maintained for a minimum period of 3 years .

4.1 All the testing equipment shall be periodically checked for continued suitability and calibrated at least once in year from NABL accredited Calibration laboratories. Calibration certificates issued by the Equipment manufacturer indicating traceability to National / International standards may be acceptable as initial calibration. Calibration of analytical equipments like Gas Liquid chromatograph, Atomic Absorption Spectrophotometer, etc, may be done as specified in the respective instrument manuals or the test methods. Records of such checks and calibration shall be maintained. The Certified reference materials used for instrument calibration and other standardisation purposes shall be procured from and shall be traceable to national or any other internationally acceptable sources as applicable.

5. The entire production of the product for which the manufacturer has been certified shall be subject to these controls as defined in Table II – Inspection and testing Plan and evaluated for its conformance to the applicable certification criteria.

6. The decision regarding conformity or otherwise of a Batch to the prescribed requirement shall be made on the basis of tests and analysis results, and review of Batch Processing Records and Batch Packaging Records

7. In respect of all other clauses of the Standard, other than those mentioned under Inspection and Testing Plan – Table II of this Internal Quality Assurance Protocol, the factory shall maintain appropriate controls and checks to ensure that their product conforms to the various requirements of the standard.

8. All products conforming the criteria shall be legibly marked with the specific Certification mark awarded to them. The manufacturer shall apply the Certification Mark and despatch only after the completion of satisfactory corrective actions and availability of satisfactory results of all tests as applicable for each Batch has been achieved.

9. Finished products should be held in quarantine until their final release, after which they should be stored as usable stock under conditions established by the manufacturer.

10. Incoming materials 10.1 Incoming starting herbal material shall be checked for compliance to criteria defined in

the API/UPI/SPI/HPI . Each consignment shall be subjected to Inspection and testing and only those found conforming shall be used for processing. If the herbal material for


processing does not comply with its quality specifications, the material shall be rejected, stored separately and disposed of.

10.2 When consignments are accompanied by a suppliers Test certificate the same maybe accepted as means of establishing conformance, and in such cases the manufacturing organization shall test samples from every 10th consignment. However if sample fails on independent testing then sample from every consignment shall be tested till confidence is assured.

10.3 Other raw materials and Packaging material - All incoming products and packaging materials to be used shall be checked on receipt for quantity, identity and conformity with the packaging instructions. The conformity assessment shall be carried in accordance with the levels of controls as given under Table I.

10.4 Packaging material shall be checked for identity and condition while issuing for packaging of the product. Outdated or obsolete primary packaging material or printed packaging material shall not be issued for use. It shall be destroyed and its disposal recorded.

10.5 Water (from any given source ) if used for processing shall be initially tested for Colour, Odour, Taste, Turbidity, pH, Total Dissolved Solids, Microbiological and Chemical requirements including Toxic Elements and Pesticides Residues. Subsequently, its quality may be regularly assessed at least once in three months through in-house testing for Colour, Odour, Taste, Turbidity, pH, Total Dissolved Solids and Microbiological requirements. If the water source is changed then all the initial tests shall be carried out before its use .

11. Non Conforming Products 11.1 As and when a Batch of finished Product is reported non conforming to specified

requirements with respect to the Microbiological Requirements , the Batch shall not be despatched. The Batch shall be rejected. The previous Batches made from the same consignment of incoming starting herbal material or those Batches in which the material of this Batch has been blended, and is available in stock shall be released into the market only after reinspection and testing confirming compliance to specified requirements.

11.2 As and when a Batch of Ayush Products is reported non conforming to specified requirements with respect to the requirements of Heavy Metal Contaminant , Pesticide residues and Aflatoxins, the Batch shall not be despatched. The manufacturer shall immediately investigate the reasons for contamination and nonconformity, undertake a root cause analysis, do a correction, initiate corrective actions. The manufacturer may reprocess the material including blending .

11.3 The previous Batches made from the same consignment of incoming starting herbal material or those Batches in which the material of this Batch has been blended , and available in stock shall be released into the market only after reinspection and testing.

11.4 As and when a Batch of Ayush Products is reported non conforming to specified requirements with respect to the other physio chemical requirements of the standard or Regulatory requirements , the Batch shall not be despatched The Batch should be clearly marked as such and stored separately in restricted areas.

11.5 The manufacturer shall immediately investigate the reasons for the nonconformity, undertake a root cause analysis, do a correction, initiate corrective actions. The manufacturer may reprocess the material including blending. A reprocessed batch shall be identified by a new batch number, and all appropriate records of Batch processing and packaging maintained.

11.6 Whenever, the quality of herbal materials / Ayush product is found to be not meeting the requirements of the certification criteria, the incoming raw materials records, in process records namely Batch processing records and Batch packing records shall be checked again for identifying and deciding upon the necessary controls to be exercised for conformance of quality of the Ayush product.

12. Hygienic conditions- The herbal material and Ayush products shall be processed, handled, stored, packed and marketed in accordance with the hygienic practices given in the applicable relevant Regulation, domestic or international, and the GMP Requirements Based


On WHO Guidelines. Compliance to these requirements shall be checked and recorded on the check list for good hygienic practices .

13. Rejected Material - Rejected materials and products should be clearly marked as such and stored separately in restricted areas. They should either be returned to the suppliers or, where appropriate, reprocessed or destroyed in a timely manner. Whatever action is taken should be approved by authorized personnel and recorded. A separate record providing the detailed information regarding the rejected materials and Batches of Ayush Products and mode of their disposal shall be maintained. Such material shall in no case be stored together with that conforming to the certification criteria.

14. Samples- The manufacturer shall permit the drawal and collection of samples from their facility for independent evaluation of the product quality by the CB. No fee shall be levied for the same.

15. 15. Replacement- Whenever a complaint is received soon after the goods with Ayush Certification Mark have been purchased and used, and if there is adequate evidence that the goods have not been misused, defective goods are replaced free of cost by the licensee, in case the complaint is proved to be genuine and the best before period (where applicable) has not expired. The final authority to judge conformity of the product to the Certification criteria shall be with the CB. The manufacturer shall have its own complaint investigation system.

16. 16. In the event of any damages caused by the goods bearing the Certification mark, or claim being filed by the consumer against Ayush Certification Mark and not “conforming to” the relevant Certification Criteria, entire liability arising out of such non conforming products shall be of the certified unit and the CB shall not in any way be responsible in such cases.

17. 17. Labelling - The finished Ayush products shall be marked legibly on the label of the bottle / package …;

a) Name of the Ayush Product; b) Dosage form (Tablet or vegetarian capsules or any other ) c) List of active Ingredients and other ingredients , showing the amount of each present

and a statement of the net contents (e.g. number of dosage units, weight, volume); d) Batch number assigned by the manufacturer; e) the expiry date in an uncoded form; f) any special storage conditions or handling precautions that may be necessary; g) directions for use, and warnings and precautions that may be necessary; h) the name and address of the manufacturer or the company or the person responsible for

placing the product on the market; i) Any others as required by the Regulation; j) The appropriate Ayush Certification mark; k) Customer care number or Helpline or Consumer complaint number

18. Suspension - The manufacturing unit shall suspend the certification voluntarily under intimation to the CB if, at any time, there is some difficulty in maintaining the conformity of the Ayush product(s) to the relevant certification criteria , or the testing equipment goes out of order. The suspension may be revoked as soon as the deficiencies are removed under intimation to the CB. The use of Certification Mark on the product shall be stopped during the suspension period.


Table I Raw Material Testing and Inspection Plan

Sl. No. Parameters Acceptance

Criteria Method of test

Frequency of test

No. of Samples

1 Description Compliance to relevant API / UPI / SPI / HPI Specification / Importing country Regulation. Test certificate with each consignment from supplier’s laboratory is acceptable for establishing conformance, and in such cases every 10th consignment to be tested.

Visual (macroscopic) and / or Microscopic

Each Consignment

One

2 Identification Visual examination and/or TLC

Each Consignment

One

3 Physio Chemical Parameters

As prescribed in API /UPI /SPI /HPI / Importing country Regulation

Each Consignment

One

4 Microbiological contaminants

Each Consignment

One

5 Pesticide residues (including Agricultural and veterinary substances)

Each Consignment

One

6 Aflatoxins Each Consignment

One

7 Heavy Metals and Non Metals

Each Consignment

One

8 Water WHO guidelines for drinking water

As prescribed in WHO guidelines for drinking water

Once in a week

One

9 Packaging Material As per documented inhouse specifications / specifications of the importing country . Test certificate with each consignment from supplier’s

As prescribed Each Consignment

One


laboratory is acceptable for establishing conformance, and in such cases every 10th consignment to be tested.


Table II Finished Product Testing and Inspection Plan

Sl. No.

Parameters Acceptance Criteria

Method of test Frequency of test

No. of Samples

1 Description Compliance to relevant API /UPI /SPI /HPI / Importing country Regulation


Each Batch One

2 Identification Microscopic; TLC

Each Batch One

3 Physio Chemical Parameters and assay, where applicable.


Each Batch One

4 Microbiological Contaminants

Compliance to relevant API/UP/SP/HP Specification / Importing country Regulation

Internationally recognized methods

Each Batch One

5 Pesticide residues (including Agricultural and veterinary substances)


Each Batch One

6 Aflatoxins (B1, B2, G1 and G2)


Each Batch One

7 Heavy Metals and Non Metals

As per Govt order no .F.No.K -11020/5/97- DCC (AYUSH ) / WHO Limits /Importing country regulations


Each Batch One

Section IV – Certification Process Version 1 Page 1 of 13

SECTION IV VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS

Certification Process

1. SCOPE OF THIS DOCUMENT This document explains the process of certification under the Voluntary Certification Scheme for Ayush Products (hereinafter referred to as the Scheme) and the requirements that should be followed in order to obtain, operate and maintain the Certification.

2. OBJECTIVE The objective of this document is to regulate the operation of the Scheme and promote uniformity in its operation and the interaction between the Certification Bodies (from now on CBs), the manufacturing organizations seeking product certification and the Department of Ayush.

3. SCOPE OF CERTIFICATION

3.1 The Ayush Certification is awarded at two levels:

a) Ayush Standard Mark which is based on compliance to the domestic regulatory requirements; and

b) Ayush Premium Mark which is based on either or both of the following options; Option A: Compliance to the GMP Requirements based on WHO Guidelines and Levels of contaminants as given in Certification Criteria document. Note

i. The requirements of heavy metals shall not be applicable to Ayush products having raw materials of metallic origin provided they are intended for domestic market.

ii. For the time being this certification is available for Herbal products only. Option B: Compliance to regulatory requirements of any importing country provided these are more stringent than Option A above. Note i. For the time being this certification is available for Herbal products

3.1.1 For any manufacturer to qualify for Ayush Premium Mark certification, compliance to the domestic regulation and having inhouse testing facilities is a prerequisite. 3.2 The elements of the Certification process are:

a) evaluation of the manufacturing facility for manufacturing and hygiene processes, and capability to manufacture Ayush products of a desired quality on a continuous basis,


b) evaluation of the quality of the Ayush product(s) for compliance to relevant certification criteria through testing of products sampled from the manufacturing facility and the market or any other source.

3.3 The Scheme is open to all manufacturing organizations that are legal entities in India. 3.4 The Department of Ayush itself is not involved in the certification of Ayush products.

It is the owner of the Certification Scheme, Certification Criteria and the Certification Mark(s). Certification is operated by independent product certification bodies duly accredited by NABCB and/or recommended by QCI.

3.5 The process by which a manufacturing organization gains and maintains certification is summarized in the document “Steps for obtaining Certification for Ayush Products”. The entire process of how to obtain certification of Ayush products is also available on the website of Department of Ayush (www….) as well as QCI (www.qcin.org).

3.6 The certification to the above mentioned criteria shall be carried out by the CBs duly accredited for the certification scheme as per ISO/IEC Guide 65, by NABCB and/or recommended by QCI. To operate under the Scheme the CBs will require an extension of scope within the accreditation for ISO/IEC Guide 65 and comply with the provisions of the document ‘Requirements for Certification Bodies’.

4. CERTIFICATION PROCESS 4.1 Registration of Application 4.1.1 The certification body shall maintain and make publicly available accurate information

describing its certification processes for granting, maintaining, extending, renewing, reducing, suspending or withdrawing product certification, and geographical areas in which it operates The information shall include

a) reference to the Certification Criteria, b) procedure for obtaining Ayush Product Certification, a detailed description of the

initial and continuing certification activity, including the application, initial evaluation, periodic surveillance evaluations, and the process for granting, maintaining, reducing, extending, suspending, withdrawing certification and recertification .

c) an Application form; d) list of documents required to be submitted along with the application. e) information about the fee for application, initial certification and continuing

certification f) documents describing the rights and duties of certified clients, and g) information on procedures for handling complaints and appeals

4.1.2 The CB shall respond to all enquiries received from prospective applicants for Ayush product certification with complete information for facilitating a registration of an applicant, within seven days of receipt of the query.

4.1.3 The prospective applicant organization manufacturing Ayush products shall apply to the Certification Body on the Application format prescribed by the CB, and provide as a minimum information on the name and address of applicant with contact details, proof of legal entity, location of manufacturing unit, products being manufactured, products and dosage form for which certification is being sought, relevant certification criteria against which certification is being sought, description of production processes, own installed/existing manufacturing and testing facilities, number of


shifts of operation, number and competence of manpower, and accessibility to external testing facilities, if required. The prospective applicant must confirm that the production facility has been in production for at least one year, and that five commercial batches of the products of dosage form for which certification is being sought, have been manufactured during the current licensed period.The prospective applicant organization shall declare whether it has been an applicant/certified under this Scheme with or by any other certification body, and if yes then shall provide the previous evaluation reports to the new certification body. The certification body may verify the information provided by contacting the earlier certification body.

4.1.4 The prospective applicant organization shall along with the application declare any judicial proceedings relating to its operations/product, any proceedings by any Regulatory body or suspension/cancellation/withdrawal of any certification/approvals under any Regulations or otherwise.

4.1.5 Certification is granted only against the current relevant certification criteria. The certification body shall review all applications for the above and ensure the same.

4.1.6 All applications for certification shall be reviewed by the certification body for adequacy and deficiencies observed, if any, shall be informed to applicant organization within seven days of receipt of application. Review of applications shall be done by a competent person. Records of review shall be maintained.

4.1.7 Only applications found to be completely filled and supported with all documents sought shall be accepted and registered in order of receipt with a unique identification number, acknowledged and records maintained. Registration shall be done within seven days of receipt of application or deficiencies communicated as per 4.1.6 above.

4.1.8 Antecedents of the applicants shall be checked in relation to the Scheme. If the manufacturing licence has been suspended / cancelled for a product or the factory during the last one year, the application from the same organization shall not be entertained.

4.1.9 Applications from organizations who have earlier either misused the Ayush Certification Mark, or have been implicated / convicted by the court, or whose earlier certificate was cancelled because of violation of terms & conditions/misuse of certification mark shall not be registered within three years of conviction/strictures by the court/cancellation of the certificate by any CB.

4.1.10 Applications from organizations found to be misusing the Ayush Certification Mark while their application is being processed for grant if certificate, shall not be processed any further, and rejected after a due notice of 15 days. Fresh applications from them shall be treated as per clause 4.1.9 given above.

4.1.11 Requests for grant of certificates from ex applicants shall be processed like a fresh applicant and the entire procedure for grant of certificate be adhered to subject to clauses 4.1.8, 4.1.9 and 4.1.10 above.

4.1.12 Certification Bodies shall reject or close all Application under the following conditions; a) if Initial Evaluation is not carried out within six months of registration of

application b) if more than 20% of samples fail on factory testing during the Initial Evaluation

and during the follow up Evaluation carried out after organization has confirmed necessary corrective actions.


c) If testing facilities are not completed within three months of Initial Evaluation, or else arrangements for testing for specified requirements in NABL accredited laboratories have not been made;

d) Non acceptance of internal quality assurance protocol within a month of Initial Evaluation;

e) Lack of competent personnel for production and testing, f) If organizations shows no progress towards completion of corrective actions

within three months of Initial Evaluation and six months of Registration of application.

g) Misuse of Ayush Certification Mark h) Evidence of malpractice i) Voluntary withdrawal of application.

4.1.13 In the event of a closure/rejection of an Application, the application fee submitted with the application may be refunded as decided by the certification body.

4.2 Initial Evaluation 4.2.1 Initial evaluation shall be carried out by a competent evaluation team in one stage for

the Ayush Standard Mark and two stages for the Ayush Premium Mark. 4.2.2 The certification body shall communicate the composition of the teams to the

applicant organization for identification of conflict of interest if any. Any objections to the team by the applicant should be examined on merit.

4.2.3 Timings and date of Initial Evaluation shall be fixed in consultation with the organization ensuring that production processes representative of normal operations will be open for witnessing during the planned Evaluations. The duration and plan for Initial Evaluation shall be provided to the applicant.

4.2.4 Initial Evaluation of the product and the processes at the site of the applicant shall be conducted within one month of registration of application and or satisfactory fulfilment of all application requirements.

4.2.5 In the initial evaluation for Ayush Standard Mark, the certification body shall list the applicable domestic regulatory requirements, verify compliance to the certification criteria and also verify competence of testing personnel and the testing facility by witnessing testing of sample(s) in the laboratory of the organization, if available.

4.2.6 During the Stage 1 evaluation for Ayush Premium Mark, the certification body shall list the applicable regulatory requirements, check the applicant’s compliance to these requirements on a sampling basis, status of GMPs, availability of competent personnel and adequate equipment for production and testing, availability of production and test records, the validation records and the state of preparedness for the Stage 2 evaluation, and prepare a report.

4.2.7 Deficiencies observed with respect to the certification criteria during the Stage 1 evaluation shall be informed in writing to the applicant.

4.2.8 The Stage 2 evaluation by certification body shall take place only after necessary actions on the identified deficiencies have been taken and confirmed by applicant. The CB may seek documentary evidence or organize an onsite visit, if necessary, to verify the implementation of corrective actions.

4.2.9 During the Stage 2 evaluation of the applicant, the team shall a) Verify and report compliance to the applicable certification criteria


b) Witness the production processes covering as many products applied for as possible;

c) Check for process controls being exercised for dosage forms and products under certification for ensuring Product quality and conformance to regulatory requirements and undertake verification of all production and test records;

d) If satisfied with b) above, draw samples of each dosage form Ayush product offered for certification, ensuring they are representative of normal production capability, as per sampling plan given below for testing in the factory as well for testing in an independent laboratory;

e) Check the availability of testing facilities in the manufacturing facility for adequacy;

f) Witness the testing of at least one sample(s) drawn for relevant important characteristics possible that can be tested in the factory testing laboratory for compliance to applicable certification criteria; If sample fails on factory testing, fresh sample to be drawn for factory and independent testing only after the organization has initiated a root cause analysis followed by corrective actions;

g) Verify competence of testing personnel and the testing facility by witnessing testing of the sample in the laboratory of the organization.

h) Draw samples for independent testing, as far as possible not to be from the same Batch as the sample drawn for factory testing;

i) Take care that Sample is drawn in such a manner so as not to contaminate the product while sampling and packing.

j) Pack and seal the samples(s) such that the product integrity is maintained for its intended shelf life.

k) Clearly identify the samples with their name and type, Batch identification and suitable identification to enable traceability to the applicant and the Initial Evaluation visit

l) Mask the identity of the sample with respect to its Brand name, and the name of manufacturer as depicted on the original packing.

m) Draw samples in quantities adequate to facilitate their testing for all requirements specified in the Criteria.

n) Ensure that if the product is affected by the conditions of temperature, handling and storage, the sample is drawn and maintained under those conditions for testing its conformity to specified criteria.

4.2.10 The certification body shall draw at least one sample of the product from one or more dosage forms for factory testing for establishing its capability to test, and sample at least 25% of the products offered within the dosage form for independent testing.

4.2.11 Any non conformities observed during Stage 2 evaluation with respect to the certification criteria shall be informed in writing to the applicant for taking necessary action. The non conformities shall be classified as Major or Minor depending on their severity.

4.2.12 A non conformity is classified as Major when it relates directly to the quality of the product and the manufacturing organizations capability to produce a product that would conform to the certification criteria.


4.2.13 A non conformity is classified as Minor when it relates to other implementation issues which do not directly affect either the quality of the product or the manufacturing organizations capability to produce a product conforming to the certification criteria.

4.2.14 Sample of each of the Ayush product drawn for independent testing shall be forwarded to an NABL accredited testing laboratory for ascertaining conformance to specified criteria. The specified criteria shall be clearly mentioned and communicated to the testing laboratory. The samples(s) shall be duly coded and as far as possible, the identity of the manufacturer shall be hidden. The sample(s) shall be so despatched that they do not get damaged and or contaminated, undergo deterioration, and the product integrity is maintained.

4.2.15 Certification Body shall maintain records of all certification activities – application registration, documents provided by applicant, on site evaluation report including factory testing results, Test reports of sample sent for independent testing.

4.2.16 An internal quality assurance protocol for controlling the quality of the Ayush product(s) during various stages of production up to its despatch based on the general Internal Quality Assurance Protocol given under this scheme shall be developed by the CB for each product/product group and given to the applicant. The applicants consent to comply with the same shall be obtained. This protocol advises the manufacturer on the protocol to be adopted for ensuring the quality of the Ayush products. This protocol covers the following; a) Definition of a Batch ; b) The frequency of tests on the raw material, if necessary , c) The controls at the intermediate stages of manufacture , d) The parameters of quality and contaminants as specified in the applicable

certification Criteria, e) Criteria for the conformity of the Batch to the various requirements of the

applicable certification Criteria, f) Sample size, g) Frequency of testing, h) Method of testing, i) List of instruments/equipments requiring periodic calibration, j) Compliance to Regulatory requirements, k) Records to be maintained. l) The format for maintaining test and other relevant records and m) Method of applying the Ayush Mark of Conformity on the product including “ Not

for Export” on all products intended for domestic market 4.2.17 The internal quality assurance protocol is a dynamic document and shall be reviewed

and amended, if required, as when the certification criteria undergo modifications and revisions or otherwise. The date of implementation of the revised internal quality assurance protocol shall be communicated to applicants to the product certification scheme and to the manufacturing unit that have been certified by the CB under this scheme.

4.2.18 A Brand Name declaration shall be obtained from the applicant indicating the Brand names the manufacturer intends to use on products covered under the Ayush Certification Scheme. The applicant shall have to provide proof of ownership of the


Brand name, and to facilitate any product recall if such a situation were ever to arise during the operation of the certification of scheme..

4.3 Grant of Certificate 4.3.1 The certification body shall ensure the following prior to processing the application for

grant of certificate : a) The availability of all relevant manufacturing and processing equipment required

for the production/manufacture of Ayush products. b) Availability of authorized and/or adequate power and water supplies, where such

supplies are required for manufacturing and testing. c) A test laboratory fully equipped to check all quality characteristics and

contaminants of the Ayush products strictly in accordance with the prescribed test procedure or an arrangement to have the same tested form an NABL accredited laboratory with the scope covering testing of Ayush products.

d) Competent and qualified personnel for production and testing of Ayush product(s).

e) Conformity of the product and raw material wherever specified, with parameters/ requirements of the certification criteria;

f) Acceptance from the applicant for following the internal quality assurance protocol, for the products for which product certification is being sought;

g) Necessary documentation for proof of legal entity and authentication of premises of manufacture where certification is being sought.

h) Verification of the applicant’s production facility having been in production for at least one year.

i) Verification of the applicant having manufactured at least five commercial batches of the products of dosage form for which certification is being sought during the current licensed period.

j) Acceptance from the applicant for other certification requirements like the fee, Brand name declaration, etc .

k) Verification of implementation of corrective actions through a follow up evaluation on site in case of major non conformities ,

l) Verification of implementation of Corrective actions for the minor non conformities by off site review, and

m) Any other requirements prescribed by the Certification Body. 4.3.2 The certification Body shall grant certification after ensuring complete compliance to

the Certification Criteria and certification scheme requirements and all non conformances have been addressed in accordance with Clause 4.3.1 above. There shall be no conditional grant of certification.

4.3.3 On grant of certification, the Certification body shall inform the organization and issue a Certificate, uniquely identified, to the organization indicating the names of the product(s) certified, the certification criteria against which the certification has been awarded, effective date, validity date, and the name and address of the organization site where certified as a minimum..

4.3.4 No Brand names of the Ayush Products shall be mentioned on the Certificate document or any other document intimating grant of certification. Licensed formulation as given on the licences shall be mentioned on the certificate document or any other document intimating grant of certification..


4.3.5 The effective date of certification shall not be before the date of decision to grant the product certification to the organization.

4.3.6 The certificate for product certification shall be for a maximum period of 3 years from the date of decision to grant the product certification.

4.3.7 The certification decision shall clearly inform the manufacturing organization that they have to seek approval from QCI (representing the Department Ayush) for using the Ayush Certification Mark on their products.

4.4 Surveillance Evaluation 4.4.1 Surveillance evaluations of the certified sites during the first certification cycle shall

be carried out at a frequency of at least once in six months, ensuring that the gap between two surveillance evaluations does not exceed six months. The Certification Body may allow a grace period of one month based on valid grounds beyond which delays shall lead to suspension of the certificate.

4.4.2 The certification body shall ensure that critical steps in an operation or a combination of production operations on a given days are witnessed , their controls verified , and samples drawn for testing both in the factory and for independent testing during the surveillance evaluation. Planning for surveillance evaluations shall ensure this

4.4.3 In case where the unit is certified to a number of products of different dosage forms under the same certificate, certification body shall plan for surveillance evaluation with a view to covering all dosage forms, and as many Ayush products within each dosage form during the certification cycle through independent testing of factory samples and market samples..The certification body shall draw more samples of products registering higher volumes in production

4.4.4 For each dosage form certified, the certification body shall ensure that as a minimum at least one sample of each dosage form from the factory and two from the market are drawn per annum for independent testing .

4.4.5 During the surveillance evaluation, the evaluators shall as a minimum check and report on the following; a) Compliance to the requirements of the certification criteria. b) Status of hygienic conditions c) Compliance to the Internal quality assurance protocol d) Handling and disposal of non conforming products e) Actions taken on discrepancies observed during the previous evaluation, failure of

samples if any reported and informed to the manufacturing unit; f) Draw samples for factory testing and testing in independent laboratory g) The continued availability of the manufacturing machinery and test equipment

and changes since the previous evaluation. In the event of changes the evaluator shall ascertain if they are adequate for control of processes and testing of the products.

h) Information on production of Ayush products and the names of consignees to whom Ayush marked products have been despatched for the purpose of market sampling.

4.4.6 If any non conformities are observed, the same shall be categorized as either a Major or a Minor. The non conformity report shall be provided to the client in writing, generally on site, for correction and corrective action. Details of the same shall be reported in the Surveillance evaluation report.


4.4.7 The certification body after completion of the first certification cycle may increase or decrease the frequency of surveillance evaluation based on the performance of the manufacturing unit not less than once a year in any case.

4.4.8 The frequency of surveillance evaluation maybe reduced to once in a year provided there have been no Major non conformities, failure of samples or complaints during the previous three years. The certification body shall revert to the normal frequency immediately in case any change in this situation occurs.

4.4.9 If the surveillance evaluation results in an infructuous visit due to any reason, and neither the production is witnessed nor products drawn for testing either in the factory or for independent testing, the CB shall conduct another surveillance evaluation. Such additional evaluations may be charged to the certified unit as decided by the Certification Body.

4.5 Market samples 4.5.1 Samples of certified products shall be purchased from the market or procured from

organized consumers and tested in NABL accredited laboratories for ascertaining compliance to requirements of the Certification Criteria.

4.5.2 The certification body shall draw a minimum of 2 samples from each dosage form product group certified from the market for each client in a year.

4.5.3 In case where the unit is certified to a number of products of different dosage forms under the same certificate, certification body shall attempt to draw the market samples in a manner so that all dosage forms and practically the entire range of products within each dosage form are covered in factory and market sampling within a certification cycle.

4.5.4 Market samples shall be drawn in the original packaging and product integrity shall be ensured by the certification body.

4.6 Failure of sample of certified product, drawn from the factory or the market, to comply to criteria requirements shall be communicated to the certified manufacturing unit for investigation, root cause analysis and proposed corrective actions within 15 days of intimation. The CB shall respond to the proposed corrective actions within 5 days and the manufacturer shall implement the corrective actions within one month from acceptance of the corrective actions by the CB.

4.7 Depending on the nature of the failure reported, the CB shall decide on one or any of the following ;

a) Draw additional samples of the product manufactured around the same time from the market;

b) Organize for an additional surveillance evaluation immediately c) Ensure fresh sample is tested in the factory; d) Increase the frequency of surveillance evaluation e) Increase the number of market samples The manufacturer shall be informed of the decision taken.

4.8 When the failure of the sample is in requirements relating to Contaminants the CB shall advise the manufacturer to;

a) Stop despatches of the failing Batch if stocks are available either at the site or in their warehouses;

b) Recall the failing Batch from the market;


c) Identify all Ayush products manufactured with same starting herbal material, or those manufactured during the same time under similar controls, and examine their Batch processing records and Batch packaging records and retest the Reference samples of these Batches in the custody of the Manufacturer; or

d) Suspend the certification, till adequate and effective corrective actions are taken.

4.9 Suspension 4.9.1 The certification body shall issue instructions to the certified manufacturing units for

suspension of certification when; a) any sample fails to conform to the requirements relating to Contaminants b) 2 consecutive samples, from the factory or market, as determined by date of

manufacture, fail to conform to the requirements of the product requirements other than contaminants;

c) Unsatisfactory performance during two consecutive Surveillance evaluations on account of any of these aspects is observed;

i. Failure of sample on factory testing (in case of failure of contaminants 4.9.1 a) above applies)

ii. Unsatisfactory hygienic conditions iii. Important testing equipment not calibrated iv. Testing equipment out of order and no alternate arrangements for testing v. Non implementation of Internal Quality Assurance Protocol vi. Non availability of testing personnel and absence of alternate

arrangements c) Unsatisfactory hygienic conditions of serious nature during a surveillance

evaluation. 4.9.2 The certification body shall issue due notice of at least one week for suspension of

certification to the manufacturing unit. In case of serious failures mentioned at 4.9.1 a) and c) above , the notice may not be required.

4.9.3 On receipt of instructions for suspension of certification, the certified units shall suspend using Ayush certification mark on Ayush products being manufactured by them with immediate effect. The manufacturing unit shall be advised to undertake a root cause analysis and identify the necessary corrective actions for resolving the same.

4.9.4 While under suspension, the certification body shall ensure that despatches of certified Ayush products to the market/customer are withheld until the product in stock has been reassessed for conformity to the criteria. The manufacturing organization shall reassess the quality of the products in stock and the CB shall verify this reassessed stock for conformity to the certification criteria before allowing its despatch.

4.9.5 The certification body shall revoke suspension only when ; a) Corrective actions have been taken and verified by the certification body. b) Reports of Samples of Ayush products manufactured after corrective actions,

both during factory and independent testing confirm compliance to Criteria requirements.


4.9.6 Suspension shall not exceed a period of six months. The manufacturing unit’s inability to resolve issues relating to suspension within this period shall lead to cancellation of certification.

4.10 Renewal 4.10.1 The certification body shall send the Renewal notice to the certified units at least four

months prior to expiry of certificate validity period. 4.10.2 The manufacturing organization shall apply for renewal in the prescribed format

along with fee, if any prescribed by the CB at least 3 months before expiry of the certification.

4.10.3 The certification body shall review the performance of the certified unit who has sought renewal of the Certificate, with respect to compliance to certification criteria during the entire certification cycle, prior to a decision on the renewal of the certificate.

4.10.4 The review shall be based on a) surveillance and renewal evaluation reports, b) Quantum of Ayush products conforming to criteria expressed as percentage of

quantity manufactured c) Handling and disposition of non conforming products d) Test reports for samples drawn from the factory and the market, e) Any suspension of certificate during the previous validity period; f) corrective actions taken g) complaints if any received, h) Adverse information, if any.

4.10.5 Renewal of certificate shall be based on the satisfactory performance of the certified units.

4.10.6 The certification Body shall not renew certification with conditions for compliance to be verified subsequently. There shall be no conditional renewal of certification.

4.10.7 When performance of the certified units is not satisfactory, the certification body shall withhold the renewal of the certificate to the manufacturing organization clearly stating the reasons and give time for effecting corrective actions. The verification and decision on renewal should be taken within 3 months of the expiry date.

4.10.8 The corrective actions shall be verified generally on site unless the CB can verify the same off site prior to considering for renewal of certificate. The justification for off site review shall be recorded.

4.10.9 The renewal shall be effected from the date of the expiry of the previous certificate and the intervening period shall be treated as period of suspension and clearly stated on the Certificate. The manufacturing unit shall not claim certification or use the Certification Mark during this period.

4.10.10 In case the manufacturing unit does not complete satisfactorily actions within three months, the certificate shall stand expired from the date of expiry of previous validity.

4.10.11 When a certificate is not renewed, it shall expire at the end of validity period. 4.11 Cancellation 4.11.1 Certification body shall cancel the certificate when ;

a) Certified unit contravenes the terms and conditions of certification and provisions of Ayush certification scheme like repeated failures of samples, suspension of


certificate, inadequate corrective actions, lack of compliance to Internal quality protocol, misuse of Ayush Certification Mark(s) etc

b) Ayush products are failing and not conforming to the requirements of the Certification Criteria and the corrective actions taken are not ensuring compliance, or the proposed plan for corrective actions will take a considerable time beyond 6 months for implementation;

4.11.2 Certification body shall cancel the product certification certificate at the request of the certified unit, if the operation(s) in the certified units premises can no longer be carried due to reasons of natural calamities such as flood, fire, earthquake etc, lock out declared by the management, or closure of business operations etc.

4.12 Change of location/Ownership/Name 4.12.1 The certified organization shall inform the CB of any change in the location of the

manufacturing unit. 4.12.2 On receipt of such information, the certification body shall issue instructions to the

certified manufacturing units for suspension of certification with immediate effect. 4.12.3 The manufacturing unit shall be subject to an evaluation at the new site like an Initial

Evaluation of an applicant. 4.12.4 If the evaluation is satisfactory, the CB shall transfer the Certificate to the new

location and the manufacturing unit shall be permitted to affix the Certification mark to the Ayush products produced therein.

4.12.5 The CB shall endorse the change of premises on the Certificate. 4.12.6 In the event of change of Ownership, the organization shall provide necessary

documentary evidence. The new management of the organization shall submit its acceptance to the agreement for Certification with the CB, Internal Quality Assurance Protocol and payment of fees. The same process shall be followed as and when an existing applicant undergoes a change in management. Such changes shall not call for a visit to the production site.

4.12.7 In case of change of Name, the manufacturer shall inform the change in the name to the CB supported with documentary evidence, and if satisfied the CB shall endorse the Certificate in the new name.

4.13 Extension of scope 4.13.1 Extension of scope of certificate for inclusion of additional dosage forms and

products therein under the same certificate shall be done after: a) ascertaining that the certified organization has requisite resources required e.g.

raw materials, process controls, manufacturing machinery, test facilities and technical skills .for dosage forms and products under extension of scope, through an on site evaluation, and

b) test reports for sample of products of the new dosage form are on independent testing found conforming to requirements of the Criteria

4.13.2 For extension of scope of certificate for inclusion of additional products within an existing dosage form of the Ayush Product under the same certificate, the certification body shall a) draw samples of additional products as per sampling plan at Cl 4.2.9 for

independent testing. b) Process for extension of scope for the additional products on the basis of test

reports of additional products in the same dosage form, provided by the


manufacturer, subject to conformity of samples on independent testing mentioned at a) above.

4.13.3 The extension of scope shall be clearly mentioned in the certificate document along with its date of inclusion for avoiding any misrepresentation or misinterpretation. Irrespective of the date of inclusion, the validity of the Certificate shall remain unchanged.

4.14 Certificate 4.14.1 The CB shall provide a certification document to the certified client that clearly

conveys, or permits identification of: a) the name and geographic location of the client whose products have been certified b) the dates of granting, extending or renewing certification; c) the expiry date or recertification due date consistent with the recertification cycle; d) a unique identification code; e) the certification criteria, including issue number and/or revision, against which the

product(s) are certified; f) the scope of certification with respect to product (s) as applicable at the identified

site; g) the name, address and certification mark of the certification body; other marks (e.g.

accreditation symbol) may be used provided they are not misleading or ambiguous; h) any other information required by the certification criteria used for certification; i) in the event of issuing any revised certification documents, a means to distinguish the

revised documents from any prior obsolete documents 4.14.2 The effective date on a certification document shall not be before the date of the

certification / recertification decision. 4.14.3 The formal certification documentation shall include the signature of the individual(s)

of the certification body assigned such responsibility. 4.15 Fee 4.15.1 A fee to be charged to the organization for various activities of the Ayush Product

certification scheme, without any discrimination between units, geographical location, size of the unit.

4.15.2 The CBs fee structure shall be publically accessible and also be provided on request. 4.15.3 CB shall notify and obtain consent to its fee structure from the organizations prior to

grant of certification. As and when the fee undergoes a change, the same shall be communicated to all including applicants and the manufacturing units certified under this scheme of certification for their acceptance.

Section V – CB Requirements Version 1 Page 1 of 12

SECTION V VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS

Requirements for Certification Bodies 1. Introduction 1.1 This document describes the requirements Certification Bodies (CBs) are expected

to meet and the process for their approval under the Voluntary Certification Scheme for Ayush Products.

1.2 The Department of Ayush does not levy any fee for approving the Product certification bodies.

2. Requirements for Certification Bodies 2.1 The Certification Body shall be registered as a legal entity in India, or shall be a

defined part of a legal entity, such that it can be held legally responsible for all its certification activities. A governmental certification body is deemed to be a legal entity on the basis of its governmental status.

2.2 The Certification Body shall be accredited to ISO/IEC Guide 65 by NABCB and/or recommended by QCI for Product certification for this Scheme.

2.3 The Certification Body shall ascertain product conformity to the applicable Certification criteria by testing the products in testing laboratories either compliant or accredited to ISO/IEC 17025. In case unaccredited labs are used, the responsibility of checking compliance to ISO 17025 shall rest with the certification body.

2.4 Certification agreement 2.4.1 The certification body shall have a legally enforceable agreement for the provision of

certification activities to its clients. Contracts and agreements for certification shall take into account the responsibilities of the parties.

2.4.2 The certification body shall ensure their certification agreement require that the client comply with the following:

a) always fulfil the certification requirements including product requirement and changes communicated by the certification body;

b) the certified product always fulfils the certification requirements; c) makes all necessary arrangements for the conduct of the evaluation, including

provision for examining documentation and records, and access to the relevant location(s), area(s), and personnel and for investigation of complaints;

d) makes claims regarding certification only in respect of the scope for which certification has been granted;

e) does not use its product certification in such a manner as to bring the certification body into disrepute and does not make any statement regarding its product certification which the certification body may consider misleading or unauthorized;

f) upon suspension or withdrawal of certification, discontinues its use of all advertising matter that contains any reference thereto and returns as required by the certification scheme any certification documents and takes any other measure;

g) endeavours to ensure that no certificate or report nor any part thereof is used in a misleading manner;

h) If the client provides copies of the certification documents to others, the documents shall be reproduced in their entirety


i) in making reference to its product certification in communication media such as documents, brochures or advertising, complies with the requirements of the certification body if applicable ;

j) uses the certification mark only on products it has found to comply with the requirements if applicable;

k) applies a mark to each certified product, or to product packaging, or on information accompanying each product if applicable;

l) keeps a record of all complaints made known to the client relating to the compliance with certification requirement and to make these records available to the certification body when requested, and

i) takes appropriate action with respect to such complaints and any deficiencies found in products , processes or services that affect compliance with the requirements for certification;

ii) Document the actions taken. iii) Verification by the certification body of (l) is performed only when the

certification scheme mandates it. m) The client shall inform the certification body, without delay, of matters that may affect its ability to conform to the certification requirements.

2.5 Responsibility for certification decisions 2.5.1 The certification body shall be responsible for and shall retain authority for its

decisions relating to certification. This includes the granting, maintaining, renewing, extending, reducing, suspending and withdrawing of certification.

2.5.2 The certification body shall only grant authority to make a certification decision, or any decision in the handling of complaints and appeals, to an individual or group that is impartial with respect to the product(s).

2.6 Management of impartiality 2.6.1 The certification body shall have top management commitment to impartiality. 2.6.2 The certification body shall make a publicly available statement that it understands

the importance of impartiality in carrying out its certification activities, manages conflict of interests and ensures the objectivity of its certification activities.

2.6.3 The body shall identify risks to its impartiality on an ongoing basis. This shall include those risks that arise from its activities, or from its relationships, or from the relationships of its personnel. A relationship that threatens the impartiality of the certification body can be based on ownership, governance, management, personnel, shared resources, finances, contracts, marketing and payment of a sales commission or other inducement for the referral of new clients, etc. However, such relationships do not necessarily present a body with a risk to impartiality.

2.6.4 If a risk to impartiality is identified, the body shall be able to demonstrate how it eliminates or minimizes such risk.

2.6.5 When a relationship poses an unacceptable threat to impartiality (such as a wholly owned subsidiary of the certification body requesting product certification from its parent or the same when the certification body belongs to a corporation or holding and other parts of it, manufacturers, etc. requests product certification to its related certification body), then certification shall not be provided.

2.6.6 Certification bodies shall document how they manage their certification business and any other activities so as to eliminate actual conflict of interest and minimize any


identified risk to impartiality. This information shall be made available to the mechanism specified in 2.7. The documentation shall cover all potential sources of conflict of interests that are identified, whether they arise from within the certification body or from the activities of other persons, bodies or organizations.

2.6.7 The certification body and any group within its control or personnel, employed or contracted, in an organization within its control shall not offer or provide consultancy on the product that it certifies.

2.6.8 The certification body and any group within its control or personnel, employed or contracted, in an organization within its control shall not offer or provide training on the product that it certifies.

2.6.9 The certification body is allowed to explain its findings and/or clarify the requirements of the normative documents but shall not give prescriptive advice or consultancy as part of an evaluation. This does not preclude normal exchange of information with the clients and other interested parties or the provision of different determination activities e.g. inspection, testing, audit, required for specific product certification schemes which is considered acceptable.

2.6.10 The certification body and (and any group within its control; or personnel, employed or contracted, in an organization within its control or organizational control) shall not offer or provide internal management system evaluations to the client or other legal entities involved in the certification process in those schemes that require the client or other legal entities involved in the certification process to perform internal management system evaluations. This also applies to that part of government identified as the certification body.

2.6.11 The certification body shall not certify a product on which a client has received consultancy or internal evaluations, where the relationship between the consultancy organization and the certification body poses an unacceptable threat to the impartiality of the certification body. Allowing a minimum period of two years to elapse following the end of the product consultancy is one way of reducing the threat to impartiality to an acceptable level.

2.6.12 The certification body's activities shall not be marketed or offered as linked with the activities of an organization that provides product consultancy. The certification body shall take action to correct inappropriate claims by any consultancy organization stating or implying that certification would be simpler, easier, faster or less expensive if the certification body were used. A certification body shall not state or imply that certification would be simpler, easier, faster or less expensive if a specified consultancy organization were used.

2.6.13 To ensure that there is no conflict of interests, personnel who have provided consultancy for, or been employed by a client, including those acting in a managerial capacity, shall not be used by the certification body to make a certification decision nor resolution of a complaint or appeal for that client within two years following the end of the consultancy or employment.

2.6.14 The certification body shall take action to respond to any threats to its impartiality arising from the actions of other persons, bodies or organizations

2.6.15 All certification body personnel, either internal or external, or committees, who could influence the certification activities, shall act impartially and shall not allow commercial, financial or other pressures to compromise impartiality.


2.6.16 The certification body shall not provide any service to the clients other than third party conformity assessment.

2.7 Mechanism for safeguarding impartiality 2.7.1 The certification body shall safeguard the impartiality of its activities and shall provide

for an Impartiality Committee mechanism through which significantly interested parties like manufacturers, suppliers, users, consumers and conformity assessment experts, can provide input on:

a) the policies and principles relating to the impartiality of its certification activities, b) counteracting any tendency on the part of a certification body to allow commercial

or other considerations to prevent the consistent impartial provision of certification activities,

c) matters affecting impartiality and confidence in certification, including openness and public perception

2.7.2 The terms of reference, duties, authorities and responsibilities of the mechanism shall be formally documented to ensure

a) representation of a balance of interests such that no single interest predominates (internal or external personnel of the certification body are considered to be a single interest, and shall not predominate),

b) access to all the information necessary to enable it to fulfill all its functions (see 2.6.6)

2.7.3 If impartiality is not being achieved by the certification body, the mechanism will be authorized to take appropriate action (e.g. informing authorities, accreditation bodies, stakeholders). In taking appropriate action, the confidentiality requirements of 2.19 relating to the client and certification body shall be respected.

2.7.4 Although every interest cannot be represented in the mechanism, a certification body shall identify and invite key interests.

2.8 Liability and financing 2.8.1 The certification body shall evaluate the risks arising from its certification activities

and that it has adequate arrangements (e.g. insurance or reserves) to cover liabilities arising from its operations.

2.8.2 The certification body shall have the financial stability and resources required for the operation of the certification system.

2.9 Resource requirements 2.9.1 Competence of management and personnel 2.9.1.1 The certification body shall have processes to ensure that personnel have

appropriate knowledge of product certification, product standards, GMPs, related normative references and relevant Regulations for the products for which product certification is being offered.

2.9.1.2 It shall determine the competence required for each technical area (stream of Ayush as relevant for the specific certification scheme), and for each function in the certification activity.

2.9.1.3 It shall determine the means for the demonstration of competence prior to carrying out specific functions.

2.9.1.4 In determining the competence requirements for its personnel performing certification, the certification body shall address the functions undertaken by


management and administrative personnel in addition to those directly performing evaluations, testing and certification activities.

2.9.1.5 The certification body shall have access to the necessary technical expertise for advice on matters directly relating to certification for technical areas in which the certification body operates. Such advice may be provided externally or by certification body personnel.

2.9.2 Personnel involved in the certification activities 2.9.2.1 The certification body shall have, as part of its own organization, personnel having

sufficient competence for managing the product certification scheme. 2.9.2.2 The certification body shall employ, or have access to, a sufficient number of

evaluators and technical experts to cover all of its activities and to handle the volume of product certification evaluations performed.

2.9.2.3 The certification body shall make clear to each person concerned their duties, responsibilities and authorities.

2.9.2.4 The certification body shall have defined processes for selecting, training, formally authorizing evaluators and for selecting technical experts used in the certification activity. The initial competence evaluation of an evaluator shall include a demonstration of applicable personal attributes and the ability to apply required knowledge and skills during evaluations, as determined by a competent evaluator observing the evaluator conducting an evaluation. (see cl. 2.9.2.16 for competence requirements of evaluators)

2.9.2.5 The certification body shall have a process to achieve and demonstrate effective evaluation.

2.9.2.6 The certification body shall ensure that evaluators (and, where needed, technical experts) are knowledgeable of its evaluation processes, certification requirements and other relevant requirements. The certification body shall give evaluators and technical experts access to an up-to-date set of documented procedures giving instructions and all relevant information on the certification activities.

2.9.2.7 The certification body shall identify training needs and shall offer or provide access to specific training to ensure its evaluators, technical experts and other personnel involved in certification activities are competent for the functions they perform.

2.9.2.8 The group or individual that takes the decision on granting, maintaining, renewing, extending, reducing, suspending or withdrawing certification shall understand the applicable standard and certification requirements, and shall have demonstrated competence to evaluate the processes and related recommendations of the evaluation team.

2.9.2.9 The certification body shall ensure the satisfactory performance of all personnel involved in the evaluation and certification activities. There shall be documented procedures and criteria for monitoring and measurement of the performance of all persons involved, based on the frequency of their usage and the level of risk linked to their activities. In particular, the certification body shall review the competence of its personnel in the light of their performance in order to identify training needs.

2.9.2.10 The documented monitoring procedures for evaluators shall include a combination of on-site observation, review of evaluation reports and feedback from clients or from the market and shall be defined in documented requirements drawn up in accordance with the relevant guidance provided in ISO 19011. This monitoring


shall be designed in such a way as to minimize disturbance to the normal processes of certification, especially from the client's viewpoint.

2.9.2.11 The certification body shall periodically observe the performance of each evaluator on-site. The frequency of on-site observations shall be based on need determined from all monitoring information available.

2.9.2.12 The personnel performing the application review shall be qualified for their understanding of the certification criteria, evaluation methods and the certification scheme.

2.9.2.13 The personnel performing the certification decision shall be qualified for their understanding of the certification criteria, certification scheme, regulatory requirements, and their ability to correctly grant or expand the scope of certification (if a scope of certification is used) on the basis that the evaluation activities, information and results are a demonstration of fulfillment of requirements of the certification criteria in accordance with the certification scheme.

2.9.2.14 When a certification body performs testing using its own resources (including contracted individuals), it shall meet the applicable requirements for competence of ISO/IEC 17025 and other documents specified by the certification scheme.

2.9.2.15 Competence of Evaluator - Every person undertaking Ayush product certification evaluations must have the appropriate qualification, training, experience and skills to perform an evaluation against the relevant Ayush certification criteria.

a) Education – The certification body shall ensure that evaluators have at least post-secondary education in any stream of science relevant to AYUSH, and knowledge of basic processes, good manufacturing and hygienic conditions in the production and testing of these products.

b) Work Experience – The evaluator shall have at least 5 years of full time post qualification experience in Ayush stream of industry, including at least two years of work in quality assurance within manufacturing, retailing, inspection or enforcement, or the equivalent. The number of years of total work experience may be reduced by one year if the evaluator has completed appropriate post graduate education in the concerned stream of Ayush.

c) Training - The certification body shall ensure that evaluators have successfully completed training in audit techniques based on ISO 19011.

d) Evaluation Experience – The certification body shall ensure that within the last three years, the evaluator has performed at least 12 mandays of Ayush evaluation in at least 4 organizations for Ayush product certification as an observer/trainee, under the leadership of a qualified Evaluator, and this demonstration has met with acceptance of the qualified Evaluator. The time spent by the observer/trainee shall not count towards time spent on evaluation.

2.9.2.16 For maintaining the qualification of the evaluator, the certification body shall ensure that evaluators have performed a minimum of 4 Ayush evaluation mandays per year.

2.9.3 Selection of the evaluation team 2.9.3.1 The certification body shall ensure the competence of the evaluation team. The

evaluation team shall have appropriate knowledge of the product, the applicable regulatory requirements, the process and the Good manufacturing practices adopted and practised in manufacturing of Ayush Products of the organization to be evaluated


and testing in case the unit has an inhouse lab.The evaluation team shall comprise of duly qualified evaluators supplemented by technical experts, if need be, meeting the competence requirements prescribed above. Initially, the certification body may use ISO 9001/ISO 22000 auditors or product certification evaluators as evaluators provided they have education and work experience similar to that prescribed above under Cl 2.9.2.15, and experience in GMP/GHP auditing/evaluation in the areas of pharmaceutical or food sector. When ever such evaluators are used, the evaluation team shall be supplemented by a technical expert. All such evaluators shall also be employed or contracted full time with the CB.

2.9.3.2 The certification body shall identify and provide the competence needed to perform the Initial Evaluation of the applicant at site considering the processes employed in manufacturing of Ayush Products, and availability of laboratory in the manufacturing unit.

2.9.4 Use of individual external evaluators and technical experts 2.9.4.1 The certification body shall use evaluators who are employed or contracted full time

with it. The ISO 9001/22000 auditors, if used as evaluators by certification body as mentioned in Cl 2.12.1 below, shall also be employed or contracted full time. In exceptional cases, it may with justification use external evaluators. However, it may use external technical experts who shall have the same education and work experience as the evaluator but mat not have audit/evaluation training or experience. It shall require external evaluators and technical experts to have a written agreement by which they commit themselves to comply with applicable policies and procedures as defined by the certification body. The agreement shall address aspects relating to confidentiality and independence from commercial and other interests, and shall require the external evaluators and technical experts to notify the certification body of any existing or prior association with any organization they may be assigned to evaluate.

2.10 Test Laboratory 2.10.1 The certification body shall test all samples of Ayush product drawn for independent

evaluation, in testing laboratories either compliant with or accredited to ISO 17025 with scope of accreditation, for ascertaining conformance to specified criteria.

2.10.2 The certification criteria against which the product is to be tested shall be clearly mentioned and communicated to the testing laboratory. The sample(s) shall be so despatched that they do not get damaged and or contaminated, undergo deterioration, and the product integrity is maintained.

2.11 Outsourcing. 2.11.1 The certification body shall not outsource any activity other than testing. 2.11.2 When the certification body outsources testing, the body doing the outsourced work

shall meet the applicable requirements of ISO/IEC 17025 and/or shall be NABL accredited

2.12 Determination of evaluation time 2.13.1The certification body shall have documented procedures for determining time required for on site evaluation. The on site evaluation time determined for each client by the certification body, and the justification for the determination, shall be recorded. In determining the on site evaluation time, the certification body shall consider, among other


things, the complexity of operations, the number of employees and the number of products offered for certification as given below;

Basic on site evaluation time for Ayush Standard Mark - 1.5 mandays (in case the unit has a lab, time for its evaluation and testing of sample(s) to be added) Basic on site evaluation time for Ayush Premium Mark - 2.5 mandays Evaluation time for each additional dosage form - Add 0.5 manday Number of employees - Add 0.5 manday each for employee strength more than 20 Full Time Equivalent, and for any multiples of 20 thereafter The minimum evaluation time as above does not include the time spent either on preparation for the evaluation or for preparing the evaluation report.

2.12.1 The certification body shall not carry out any on site evaluation of duration lesser than as specified above, as testing for capability and verification of all production and testing records are an essential component of every on site evaluation. This includes all evaluations including those for surveillance, extension of scope etc.

2.13 Internal Quality Assurance Protocol 2.13.1 A generic internal quality assurance protocol for controlling the quality of the Ayush

product(s) during various stages of production upto its despatch has been developed (Annex A). Based on this the Certification body shall develop an Internal quality Assurance protocol for each product for every certified client , customized around the clients operations defining the requisite controls that need to be exercised by the client at all stage of production for ensuring compliance to the certification criteria. As a minimum all requirements given in the generic internal quality assurance protocol shall be a part of the internal quality assurance protocol developed for every client. . The Certification Body shall provide this Internal Quality Assurance Protocol to the applicant and the certified units, if amended subsequent to certification, and their acceptance to abide by the same in their operations obtained.

2.13.2 The Internal Quality Protocol shall address the following; a) Definition of a Batch / control unit; b) The frequency of tests on the raw material, if necessary c) The controls at the intermediate stages of manufacture d) The parameters of quality and contaminants as specified in the applicable

certification Criteria against which certification is being sought, e) Acceptable limits for conformity to the various requirements of the relevant

certification criteria, f) Sample size, g) Frequency of testing, h) Method of testing, i) List of instruments/equipments requiring periodic calibration j) Compliance to Regulatory requirements, and k) Records to be maintained. l) The format for maintaining test and other relevant records m) Method of applying the Ayush Certification Mark on the product.

2.13.3 The internal quality assurance protocol is a dynamic document and shall be reviewed and amended, if required, as when the Certification Criteria / applicable Regulations undergo modifications and revisions. Date of implementation of the revised internal


quality assurance protocol shall be communicated to applicants to the product certification scheme and to the manufacturing unit that have been certified by the certification body under this scheme.

2.14 Publicly available information 2.14.1 The certification body shall maintain a website for providing information about the

Scheme. 2.14.2 The certification body shall maintain and make publicly available information

describing its evaluation processes and certification processes for granting, maintaining, extending, renewing, reducing, suspending or withdrawing certification, and about the certification activities and geographical areas in which it operates.

2.14.3 Information provided by the certification body to any client or to the marketplace, including advertising, shall be accurate and not misleading.

2.14.4 The certification body shall make publicly available information about applications registered and certifications granted, suspended or withdrawn.

2.14.5 On request from any party, the certification body shall provide the means to confirm the validity of a given certification.

2.15 Certification documents 2.15.1 The certification body shall provide certification documents to the certified client by

any means it chooses. 2.15.2 The effective date on a certification document shall not be before the date of the

certification decision. 2.15.3 The certification document(s) shall identify the following:

a) the name and geographic location of each client who have been certified under the product certification scheme ;

b) the dates of granting, extending or renewing certification; c) the expiry date or recertification due date consistent with the recertification cycle; d) a unique identification code; e) the certification criteria document, including issue number and/or revision, used for

evaluation of the certified client and the products ; f) the scope of certification with respect to dosage form, product as it appears on the

licence document, as applicable at the site; g) the Certification mark for which certified; h) the name, address of the certification body, i) other marks (e.g. accreditation symbol) may be used provided they are not

misleading or ambiguous; j) any other information required by the certification criteria document used for

certification; k) in the event of issuing any revised certification documents, a means to distinguish the

revised documents from any prior obsolete documents. 2.16 Directory of certified clients 2.16.1 The certification body shall maintain and make publicly available a directory of valid

certifications that as a minimum shall show the name, relevant certification criteria (normative document), scope and geographical location (e.g. city and country) for each applicant and certified client.

2.17 Reference to certification and use of marks


2.17.1 The certification body shall ensure that the applicants are not applying the Certification mark on products prior to certification.

2.17.2 The certification body shall ensure that the Certification mark is affixed only to products covered under the scope of the certificate.

2.17.3 The certification body shall ensure that the size, colour of the Certification mark is as prescribed by the Department of Ayush.

2.17.4 The certification body should not allow the accreditation mark to be used on products.

2.18 Confidentiality 2.18.1 The certification body shall, through legally enforceable agreements, have a policy

and arrangements to safeguard the confidentiality of the information obtained or created during the performance of certification activities at all levels of its structure, including committees and external bodies or individuals acting on its behalf.

2.18.2 The certification body shall inform the client, in advance, of the information it intends to place in the public domain. All other information, except for information that is made publicly accessible by the client, shall be considered confidential.

2.18.3 In the event of a transfer of certificate the accepting certification body shall seek and as deemed necessary verify information about the certified client and status of non conformities, evaluation reports, complaints if any etc., and the previous certification body shall provide the same, under intimation to the certified client.

2.18.4 Except as required in this document, information about a particular client or individual shall not be disclosed to a third party without the written consent of the client or individual concerned. Where the certification body is required by law to release confidential information to a third party, the client or individual concerned shall, unless regulated by law, be notified in advance of the information provided.

2.18.5 Information about the client from sources other than the client (e.g. complainant, regulators) shall be treated as confidential, consistent with the certification body's policy.

2.18.6 Personnel, including any committee members, contractors, personnel of external bodies or individuals acting on the certification body's behalf, shall keep confidential all information obtained or created during the performance of the certification body's activities.

2.18.7 The certification body shall have available and use equipment and facilities that ensure the secure handling of confidential information (e.g. documents, records).

2.18.8 When confidential information is made available to other bodies (e.g. accreditation body, agreement group of a peer assessment scheme), the certification body shall inform its client of this action.

2.19 Information exchange between a certification body and its clients 2.19.1 Information on the certification activity and requirements- The certification body

shall provide and update clients on the following: a) a detailed description of the initial and continuing certification activity, including the

application, initial evaluation, surveillance evaluation, and the process for granting, maintaining, reducing, extending, suspending, withdrawing certification and recertification;

b) the certification criteria defined by the Department of Ayush for certification to clients whose products have been certified under Ayush Premium Mark;


c) information about the fees for application, initial certification and continuing certification;

d) the certification body's requirements for prospective clients i) to comply with certification requirements, ii) to make all necessary arrangements for the conduct of the on site

evaluations, including provision for examining documentation and the access to all processes and areas, records and personnel for the purposes of initial certification, surveillance, recertification and resolution of complaints, and

iii) to make provisions, where applicable, to accommodate the presence of observers (e.g. accreditation assessors or trainee evaluators);

e) documents describing the rights and duties of certified clients, including requirements, when making reference to its certification in communication of any kind in line with the requirements in 2.18;

f) information on procedures for handling complaints and appeals. 2.19.2 Notice of changes by a certification body - The certification body shall give its

certified clients due notice of any changes to its requirements for certification. The certification body shall verify that each certified client complies with the new requirements.

2.19.3 Notice of changes by a client - The certification body shall have legally enforceable arrangements to ensure that the certified client informs the certification body, without delay, of matters that may affect the capability of the clients system to continue to fulfil the requirements of the standard used for certification. These include, for example, changes relating to

a) the legal, commercial, organizational status or ownership, b) organization and management (e.g. key managerial, decision-making or technical

staff), c) manufacturing sites, d) scope of operations under product certification, and e) major changes to the manufacturing unit and processes.

2.20 Transfer of Certification 2.20.1 Certificates granted by an NABCB accredited certification body are eligible for

transfer to another NABCB accredited certification body. 2.20.2 Transfer should normally only be of a current valid accredited certificate but, in the

case of a certificate issued by a certification body that has ceased trading, or that has had its accreditation withdrawn, the accepting certification body may, at its discretion, consider such a certificate for transfer on the basis described in this guidance.

2.20.3 The accepting Certification body shall ascertain the reasons for seeking a transfer, establish that the client’s certified activities fall within the accredited scope of the accepting certification body.

2.20.4 The accepting certification body shall verify the validity of certification, status of outstanding nonconformities with the issuing certification body unless it has ceased trading. Outstanding nonconformities should be closed out, if practical, with the issuing certification/registration body, before transfer. Otherwise they should be closed out by the accepting certification/registration body.


2.20.5 Certificates which are known to have been suspended or to be under threat of suspension should not be accepted for transfer.

2.20.6 The accepting certification body shall issue a certificate, dated from the date of completion of the review, following the normal decision making process.

3. Product Certification Bodies Approval Process 3.1 The Ayush Certification Mark(s) are owned by the Department of Ayush for depicting

the product conformity to the appropriate certification criteria. 3.1.1 The certification body shall ensure that the Ayush Certification Mark(s) is affixed only

on products conforming to the Certification Criteria in the prescribed design, size and colour.

3.2 All certification bodies that have been accredited by NABCB as per ISO/IEC Guide 65 for the Voluntary certification for Ayush Products and/or recommended by QCI shall be authorized for operating the certification scheme.

3.3 These certification bodies shall monitor the usage and application of the Ayush Certification Mark(s) by the manufacturing units who are applicants with them or certified by them.

3.4 The Department of Ayush shall maintain information about approved certification bodies on its website.

3.5 QCI shall maintain information relating to approved certification bodies on its website. 4. Obligations of the product certification body approved under the Scheme 4.1 The approved product certification body shall commit to fulfill continually the

requirements for approval set by Department of Ayush for the areas where approval is sought or granted.

4.2 The approved product certification body shall claim approval only with respect to the scope for which it has been granted approval.

4.3 The approved product certification body shall not use and permit the use of the Ayush Mark in such a manner as to bring the Department of Ayush into disrepute.

4.4 The approved product certification body shall inform without delay, any significant changes relevant to its approval to the Scheme secretariat in QCI as well as NABCB, in any aspect of its status or operation relating to; a) its legal, commercial, ownership or organizational status, b) the organization, top management and key personnel, c) main policies, d) resources and premises, e) scope of accreditation, and f) other such matters that may affect the ability of the Product certification body to

fulfill requirements for accreditation.

Section VI – Obtaining Certification Version 1 Page 1 of 4

SECTION VI VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS

Obtaining and Maintaining Certification STEP I Planning for Product Certification 1. Obtaining certification against the Certification Criteria represents a challenge to

manufacturers of Ayush products. 2. It is therefore essential that the organizations interested in obtaining this certification

consider carefully a) what Ayush Certification they wish to achieve, b) identify the Criteria, and c) what needs to be achieved prior to applying for product certification.

STEP II Preparation 1. Obtain the relevant Certification Criteria documents namely the Domestic Regulations

under the Drugs and Cosmetics Act, GMP Requirements based on WHO Guidelines, Levels of Contaminants, and Regulations of the importing country (if applicable);

2. Assess your process and product for compliance to relevant Certification Criteria. 3. Undertake preparations so as to ensure that the processes and the Ayush product being

manufactured would comply with the requirements of the relevant Certification Criteria. 4. Install inhouse testing facilities if seeking certification for Ayush Premium Mark. 5. Confirm that your production facility has been in production for at least one year. 6. Verify that five commercial batches of the products of dosage form for which certification

is being planned to be sought, have been manufactured during the current licensed period.

STEP III Self assessment 1. Review your current systems and practices against the requirements of the latest

relevant Certification Criteria. 2. Identify areas which need to be addressed and ascertain compliance prior to applying for

product certification. 3. Please note that Certification Bodies are not permitted to provide consultancy although

they can identify deviations from the relevant Certification Criteria requiring correction and/or corrective action.

STEP IV Select a Certification Body 1. Select an approved Product Certification Body to carry out the evaluation for Product

certification at your site. Only Product Certification Bodies that are accredited by NABCB/recommended by QCI can certify for Ayush Product certification.

2. In selecting a certification body, consider the range of products covered under the scope of accreditation of the Product Certification Body. Information on scope of accreditation is available on the websites of Department of AYUSH (www.indianmedicine.nic.in) and QCI (www.qcin.org) or can be obtained from the concerned certification body, either through correspondence or by visiting their website.

3. Certification Bodies will require details of your site, operations, products and relevant certification criteria on a prescribed Application form for registration of your Application


for grant of product certification. Obtain the prescribed application form from the selected Certification body.

4. Submit the application form duly filled to the selected certification body along with the following documents;

a) Proof of being a legal entity b) Valid Manufacturing Licence ; c) Proof of Address of production site; d) List of installed manufacturing equipment; e) List of Testing facilities, if available; f) Copy of a test report covering all requirements of the relevant certification criteria

for the product applied for; test report could be either from own laboratory or from an NABL accredited external laboratory,

g) self evaluation checklist confirming that all requirements as prescribed in the relevant certification criteria are being complied with.

STEP V Registration and Evaluation by a Certification Body 1. The certification body will examine your application for completeness and adequacy, and

deviations if any, will be informed to you for necessary correction and/or compliance. Once the application is found to be complete, it shall be registered by the Certification body.

2. The certification body will determine the duration of the evaluation at your site, on the basis of the number of products to be certified, the manpower, the complexity of operations and processes, and availability of lab and quote to you.

3. On acceptance of its quote, the Certification body shall in consultation with you finalize the dates for evaluation.

4. It is important that the facility is in production at the time of the Evaluation by the certification body otherwise another evaluation may have to be organized.

5. The certification body will carry out the evaluation in one stage for Ayush Standard and in two stages for Ayush Premium Mark. During the Stage 1 evaluation, your state of preparedness, status of GMPs and availability of competent personnel and equipment for production and testing will be assessed for their adequacy.

6. At the end of Stage 1 evaluation the Certification Body will inform the applicant in writing about the deficiencies observed, if any, with respect to the certification criteria.

7. Take necessary actions and inform the certification body as soon as possible but not later than 3 months of the Stage 1 Evaluation. Delays beyond this will lead to another Stage 1 evaluation of your facility by the certification body.

8. The certification Body will undertake the Stage 2 evaluation only after you have confirmed that necessary actions on the identified shortfalls have been taken.

9. For the stage 2 evaluation the certification body will visit the facility and evaluate the process and controls being implemented, the prevailing hygienic conditions, the testing facilities and the competence of the personnel for compliance to the certification criteria.

10. The certification body will draw samples of products from stocks that are representative of normal production capacities of the facility, and have the same tested in an independent laboratory accredited by NABL, for compliance to the certification criteria.

STEP VI Follow up and Corrective actions


1. At the end of Stage 2 evaluation the Certification Body will inform the applicant in writing of the deviations observed, if any, with respect to the certification criteria.

2. Take necessary actions and inform the certification body as soon as possible. If you do not show progress towards completion of corrective actions within three months of Initial Evaluation your application shall be closed.

3. If the corrective actions can be verified through documented evidence, you will be required to provide the same to the Certification Body for verification of corrective actions. However if verification of corrective action is to be undertaken at the manufacturing site or if a follow up evaluation is required is only possible at site, the Certification body evaluator visits the site for confirmation of the identified corrective action only or for follow up of non conformities identified during the previous evaluation.

4. If the sample drawn fails on independent testing, you will be informed of the same and advised to take necessary corrections for improving the product quality.

5. After taking the corrective actions, you must re-offer the products for sampling and testing by the certification body. The Certification body plans another visit to the site, verifies the corrective actions taken by the organization and draws the fresh sample from a stock of material that is representative of the normal production capacity of the organization.

STEP VII Certification decision 1. The Certification Body will review the onsite Stage 1 (if applicable) and Stage 2

evaluation reports, corrective action documentation provided by the applicant and verified if so required by the Evaluation team, and the independent test report(s) in order to make a certification decision.

2. Certificate shall be awarded to the manufacturer only for the range of products applied for and offered for evaluation and testing.

3. The decision for certification will be taken only when all requirements of the Scheme have been complied with.

4. The Certificate shall be awarded for fixed time tenure of 3 years, during which your operations and the products will be subjected to surveillance evaluations and testing, and beyond the 3 years period of validity the certificate will be renewed subject to ongoing compliance

5. The certification process should be completed within 12 months of the registration of the application failing which the certification body would reject your application.

STEP VIII Issue of a Certificate by Certification Body 1. The Certification Body issues a certificate to the manufacturer indicating that the

requirements of the certification scheme have been met with and that the products conform to the relevant certification criteria. The name of the manufacturer with address of site, names of products, and the relevant certification criteria are clearly mentioned on the Certificate, along with effective date of certificate, validity of the certificate, name and address of the Certification Body and applicable logos.

2. The certificate should be issued within 7 days of the certification decision. 3. The Certification Body immediately informs the QCI about the grant of product

certification.


STEP IX Agreement for usage of Ayush Certification Mark(s) 1. The Ayush Certification Mark(s) is not available for download from the Ayush website/

any website. 2. Apply for authorization for affixing the applicable Certification Mark on Ayush products for

which you have been certified by the Certification body, on a prescribed format, which can be downloaded from the QCI website.

3. Submit the application form duly filled to the QCI secretariat . 4. Enter into a legally enforceable agreement with QCI authorizing you to affix the

Certification Mark on the products for which you have been certified. 5. Based on this, the QCI website is updated with the name and address of the Ayush

manufacturer, the product covered in the scope of certification, the criteria against which certified, the Certification mark awarded, effective date of certificate and its validity.

STEP X Maintaining Certification 1. Ensure that production and testing facilities are maintained in working order and technical personnel are available at all times 2. Implement Internal Quality Assurance Protocol provided by the CB and maintain records 3. Inform production schedules to the CB when asked for 4. Ensure that the products certified under the Scheme comply with the Certification criteria – this will be checked by the CB through factory evaluation and market surveillance. Using the Ayush Certification Mark(s) 1. The Ayush Certification Mark(s) is for use only by organisations that have achieved

product certification. 2. The Ayush Certification Mark(s) is to be affixed on the product and its packaging to

depict product conformity to requirements of the Ayush certification criteria. 3. The Ayush Certification Mark(s) shall be affixed only on products conforming to relevant

certification criteria, and non conforming products shall not to be marked with Ayush Certification Mark(s).

4. The Ayush Certification Mark(s) is owned by the Department of Ayush and provided on its behalf to the certified unit. The Ayush Certification Mark(s) can be used on all the manufacturing unit’s communication tools such as company vehicles, letterheads, compliment slips, business cards, marketing collateral, advertising, exhibition graphics, electronic media.

5. Misuse of the Ayush Certification Mark(s) would invite actions including rejection of application or suspension/cancellation of certification.

For any information, contact : Quality Council of India 2nd Floor, Institution of Engineers Building 2, Bahadur Shah Zafar Marg New Delhi - 110002 Tel: +91-11-2337-8056/57,9321,9260 Fax: +91-11-23379621 Email: [email protected]

Section VII – Use of Mark Version 1 Page 1 of 2

SECTION VII VOLUNTARY CERTIFICATION SCHEME FOR AYUSH PRODUCTS

Approval for Use of Certification Mark to Certified Units

1.1 This document describes the process that manufacturing units certified under the Scheme are expected to meet for obtaining approval for the use of relevant Ayush Certification Mark.

1.2 The Ayush Certification Mark(s), Ayush Standard Mark and Ayush Premium Mark, are owned by the Department of Ayush for depicting the product conformity to the relevant certification criteria.

1.3 Manufacturing units that have been certified under the Scheme are eligible to apply for approval for use of the Certification Mark(s) on the Ayush products being manufactured by them.

1.4 The Department of Ayush does not levy any fee for approval for use of Certification Mark to Certified Manufacturing Units.

1.5 The form for Approval for Use of Certification Mark seeking information on name and address of the manufacturing unit, the products covered under the Certificate, the relevant certification criteria, the Certificate number and the validity period, can be downloaded form the website of the QCI.

1.6 The Certified manufacturing units shall submit the form duly filled in along with a copy of the Certificate or letter informing grant of certification by the approved CB under the Scheme to QCI.

1.7 The relevant Certification Mark for the certified manufacturing unit is determined by QCI on the basis of the Certification Criteria mentioned on the Certificate issued by the CB.

1.8 The certified manufacturing unit signs a legally enforceable agreement with QCI whereby it is allowed to use the Certification mark agreeing to :

a) Use only the Certification mark specified by the Department of Ayush; b) Apply the Certification Mark only to products covered under the

product certification; c) Apply the Certification Mark on Ayush products conforming to the

certification criteria; d) Apply it as per the design and size in the colour scheme prescribed; e) Not to make any misleading claims with respect to the Certification

mark. f) Inform the certification body, about the quantum of production covered

under the Ayush Certification Mark(s), at the end of every quarter.

Section VII – Use of Mark Version 1 Page 2 of 2

1.9 QCI maintains and updates the directory of certifications granted under the Scheme posted on its website. The directory carries details of all certificates with their status, name and address of the certified clients, products covered under scope of certification, certification criteria, approval to use Ayush Standard Mark or Ayush Premium Mark, and name of the certification body.

1.10 All certification bodies that operate the Scheme are permitted to use the Ayush Certification Mark(s) on their stationary, media for exchange of any communication, for promoting the awareness of the scheme, the Certification Mark(s) as well as for informing that they are operating the voluntary certification scheme.

1.11 The approved product certification body shall not use and permit the use of the Ayush Certification Mark in such a manner as to bring the Department of Ayush into disrepute.

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