Ayurved GMP

8/7/2019 Ayurved GMP

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Ayurvedic PharmacyCurrent Concepts and GMP Norms



Food

Drug

Poison



Priyogah shamyet vyadhim yahanyamanyamudiret;

Naso vishudhah shudhastu shamyedwauna kopyet.

(Vagbhatta A. H. Su. 13:16)

The therapy which pacifies diseases and gives

rise to other diseases is not pure therapy.The pure is one which pacifies without

erupting other problems.



Ayurvedic Medicines

Herbal MedicinesHolistic Medicines(Health Restoration)

ModernMedicines

(Disease Management)

Red PharmacyGreen Pharmacy



Green Facts Current Global Market: US$150 billion (As per WHO)

Projection for 2050: US$5000 billion (As per WHO)

Chinese Foreign Exchange: Rs 22,000 Crores

Indian Share: Rs 500 Crores

Chinese Plant Resource: 30%

Indian Plant Resource: 30%

Indian System: Time tested, trusted and wellstructured

Chinese System: Not so well trusted and structured

Some Recent Greens: Ranbaxy, HLL, Colgate



Export of Herbal

Products From India



Manufacturing

Quality Control

Quality Assurance



Good PracticesGood Manufacturing Practices

Good Laboratory Practices

Good Agricultural Practices (WHO/ Feb 2004)



The RegulationDrugs and Cosmetics Act 1940(Section 33-N)

Drugs and Cosmetics Rules 1945

Drugs and Cosmetics (Amendment) Rules 1999

Schedule T



Schedule T Raw materials used in manufacturing of drugs are

authentic, of prescribed quality and free fromcontamination.

The manufacturing process is as has beenprescribed and maintains standards of purity.

Adequate quality control measures are taken and

The manufactured drug which is released for sale isof acceptable quality.

To achieve the objectives listed above each licensee shall evolvemethodology and procedures for manufacture of drugs whichshould be documented as a manual and kept for reference and inspection.

(Vaidyas, Sidhdhas and Hakeems dispensing medicines to their own patients are exempted)



GMP NormsFactory PremisesThe manufacturing plant should have adequate space for:

1. Receiving and storing raw materials

2. Manufacturing process areas3. Quality control unit including in-house

testing facilities

4. Finished goods store

5. Office

6. Rejected goods store(Minimum for any one system 1200 sq feet covered area with separate

cabins for each activity. Additional 400 sq feet for each additionalsystem)



GeneralR

equirements Location and Surroundings

Away from open sewage, drain, public lavatoryand factories producing obnoxious odor, fumes,

dust or smoke. Buildings

Hygienic and free from cobwebs, insects androdents

Designed to prevent Cross-contamination

Water Supply Potable & Other

Disposal of Waste

Predisposal Treatment



Health, Clothing, Sanitation and Hygiene

of Workers Workers to be free from contagious diseases

Uniform Suitable for climate and nature of work including

coverings for hands, feet and head wherever required

Facilities for personal cleanliness Clean towels, soap, scrubbing brushes, lavatories,

change rooms & place for keeping personalbelongings.

Medical Services First aid

Medical Examination: At the time of employmentand at least once in a year



Raw Materials

Separate and adequate facilities for Raw materials of metallic origin

Raw materials of mineral origin Raw materials from animal source

Fresh herbs

Dry herbs or plant parts

Excipients etc. Volatile oils, perfumes and flavors

Plant extracts, exudates and resins

Labeling: µUNDER TEST¶ or µAPPROVED¶ or µREJECTED¶



Packaging MaterialStorage

Testing

Cleaning

Controls on printed materials to avoidwrong labeling



Working Space Adequate for orderly placement of

equipments and materials

To facilitate easy and safe working

To minimize/ eliminate risk of mix-upsand cross contamination



Equipments Nature, number and sizes

Installation and maintenance record

Cleaning SOPs and Records Operation SOPs

e.g. Anjana/ Pisti: Kharel/ ball mill, sieves/ shifter

Churna: Grinder/ disintegrator/ pulverizer, powder mixer, sieves/ shifter

Ark: Maceration tank, distillation plant, liquid filling

tank with filter/ filter press, visual inspection box



Finished Goods StoreQuarantine Area

Approved Finished Goods Stock Area



Quality Control Lab

Personnel: To be headed by an independentperson.

Duties: To prepare specifications and testing methods for

raw materials and finished products.

To sample, test, approve or reject RMs, PMs,

semi-finished product and finished products. To supervise and monitor the adequacy of storage

conditions.

Maintenance of the records of each processwhere testing of finished product is not possible.



Records

Batch Manufacturing Records (BMR)

Distribution Records (to facilitate recall)

Record of Market Complaints and Adverse Drug Reactions



B. Pharm./ M. Pharm. (Ay)Quality Control, Legal Aspects & Documentation

1. Quality Perspectives of Ayurvedic-herbal Products:Status of quality standards for Ayurvedic-herbal products.Databases for identification and authentication of materials.

Chemoprofiling & bio-profiling of Ayurvedic-herbal products.Protocols for establishing purity of materials, identificationof adulterants, substitutes, pathogenic bacteria & fungi,heavy metals and pesticide residues. Validation of traditional claims through scientific studies and clinicaltrials.

2. Quality Control: Control of manufacturing processes,statistical quality control, control charts, sampling plans,automated process controls, dosage form controls, Testingprograms methods. Product identificationsystems, adulteration & misbranding. Maintenance of records. Bioavailability & bio-equivalence. Manufacturer¶s

reliability. Manufacturer/drug information profile.



3. Good Manufacturing Practices:GMP in manufacturing,processing, packaging and holding of drugs. Control of Components, containers and closures. Packaging &

labeling controls. Inspection for compliance with GMP.Potable water standards. Premises- design, construction,maintenance, equipments. Warehousing.

4. Pharmaceutical Process Validation:Regulatory basis,validation of sterile products & non-sterile products andprocesses thereof. Analytical method validation. Validationof computer assisted processes.

5. Drug Regulatory Aspects: National and internationalbodies for drug regulation. Federal food, drug and cosmeticacts along with recent amendments. New drug application,drug efficacy study, implementation review, OTC drug

review, drug listing. Drug recalls, product liability, clinicaltrials. ICH guidelines. WHO & ISO certification. Patents,copyright & trade marks.

6. Documentation:Relevance and importance of documentation, statuary requirements and procedure for

documentation, critical examination of documents.

Ayurved GMP

Documents

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