ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM

Project co-financed by European Union Project co-

financedby Asean

European Committee for StandardizationImplementing Agency

1Module 1Module 1

GMP Workshop Kuala Lumpur 14-GMP Workshop Kuala Lumpur 14-16 November 200516 November 2005

Prepared byHui Foong Mei – Singapore

Vongsavanh Insixiengmay – Laos PDRDavong Oumavong – Laos PDR

Approved byASEAN Cosmetic GMP Team

Endorsed byASEAN Cosmetic Committee

ASEAN GMP TRAINING MODULEQUALITY MANAGEMENT

SYSTEM


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Module 1Module 1 GMP Workshop Kuala Lumpur 14-GMP Workshop Kuala Lumpur 14-

16 November16 November2

CONTENT OF PRESENTATION

1. Basic Principles of Quality Managementa. Basic Principles of Quality Assuranceb. Basic Requirements of Quality

Assurancec. Basic Principles of GMPd. Basic Requirements of GMPe. Basic Principles of Quality Controlf. Basic Requirements of Quality Control

2. Basic Principle of Quality Documentation

3. Establishment of Quality Manual


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To understand key concepts of quality management, quality assurance, GMP and quality control.

To understand level of quality documentation.

To understand specific requirements on quality manual.

To develop quality manual based on GMP requirements

OBJECTIVES


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BASIC PRINCIPLE

OF QUALITY MANAGEMEN

T


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Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD).

They should also comply with any other applicable regulations pertaining to your specific country.

The attainment of this quality objective should be led by the senior management and requires the participation and commitment by staff, by the company’s suppliers and distributors.

BASIC PRINCIPLE OF

QUALITY MANAGEMENT (1)


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To achieve the reliable quality objective, there should be a comprehensive QA system incorporating GMP.

The QA system should be fully documented and its effectiveness should be monitored.

All parts of QA system should be adequately resourced with:

competent personnelsuitable and sufficient premises, equipment and facilities

BASIC PRINCIPLE OF

QUALITY MANAGEMENT (2)


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QA covers all matters which individually or collectively influence the quality of a product.

It refers to a sum total of activities organized with an aim to ensure the products are of the required quality.

QA incorporates GMP and other factors that fall outside the scope of the GMP Guide.

BASIC PRINCIPLE OF

QUALITY ASSURANCE (1)


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Ensure that products are designed and developed based on sound scientific rationale and with GMP or GLP (Good Laboratory Practice) principles being taken into consideration.

Ensure that managerial responsibilities are clearly specified.

Ensure that production and control operations are clearly specified and GMP is adopted.

Organize supply and use of correct starting and packaging materials.

Ensure that finished products are correctly processed and checked before release.

BASIC REQUIREMENTS OF


STATEMENTOF

RIGHTS&

RESPONSIBILITIES


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Ensure that products are released after review by authorised person.

Provide satisfactory arrangement to ensure products are stored, distributed & handled appropriately.

Put in place a mechanism for regular self inspection / internal quality audit.




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Part of QA which ensures that products are consistently produced and controlled to the quality standards appropriate to their intended use.

Minimize risks :• cross contamination • mix up

Ensure products/materials are traceable to the original source.

Product testing is not reliable way to assure product quality. Should BUILD quality into the product!

Production and quality control functions should be independent of each other.

BASIC PRINCIPLES OF

GOOD MANUFACURING PRACTICES


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All manufacturing process are clearly defined and systematically reviewed.

All necessary facilities/resources for GMP should be provided :

adequate, qualified and well-trained personnelsuitable premises and sufficient spacesuitable locationgood personal hygiene and proper sanitationsuitable equipment and services

BASIC PRINCIPLES OF

GOOD MANUFACURING PRACTICES (1)


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All necessary facilities/resources for GMP should be provided : clearly defined manufacturing processes using unambiguous language good documentation system appropriate storage and transport systematic internal quality audit proper product recall system right handing of complaints comprehensive corrective and

preventive action

BASIC PRINCIPLES OF

GOOD MANUFACURING PRACTICES (2)


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QC is part of GMP.

QC is concerned with sampling, specification and testing.

Manufacturer should have a QC department.

QC should be headed by an appropriately qualified and experienced person.

QC should be independent from production and other departments.

Ensure that the necessary and relevant tests are actually carried out.

Ensure that no materials or products will be released for sale or supply, until their quality have been evaluated and judged to be satisfactory.

BASIC PRINCIPLES OF

QUALITY CONTROL (1)


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Items concerned :Starting materialsPackaging materialsBulk productsIntermediate and finished productsEnvironmental conditions

SCOPE OF QC


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Adequate facilities, trained personnel and approved procedures should be available for sampling,

inspecting and testing and, where appropriate, environment monitoring.

Sampling by QC personnel & testing by approved methods.

Approved test methods.

Maintenance of QC records & failure investigation records.


QUALITY CONTROL (1)


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Ingredients comply with regulatory specification (grade, composition, strength)

Review and evaluation of production documentation

Assessment of process deviations

Release of batches by authorised person

Sufficient reference samples of starting materials and finished products


QUALITY CONTROL (2)


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Establish QC proceduresManage reference standardsEnsure correct labelingStability testing (if applicable)Complaint investigationEnvironmental monitoring

OTHER DUTIES OF QC


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Should include the following:Production conditionsIn process quality control activity Manufacturing documentationCompliance with finished product specificationExamination of the finished products

QC AccessQC personnel MUST have access to production area for sampling and investigationAccess to QC lab is strictly for QC personnel

QUALITY CONTROL ASSESSMENT OF

MANUFACTURING ACTIVITY


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QC should cover the following:a. Samplingb. Specificationc. Testingd. Release procedurese. Recalls and complaintsf. Decision making in all quality

mattersg. Definition of product qualityh. Laboratory operationsi. Release authorisationj. Investigation and reporting

QUALITY CONTROL ACTIVITIES


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Quality Management

Quality Assurance

G.M.P.

Quality Control

QUALITY RELATIONSHIP


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BASIC PRINCIPLE OF

DOCUMENTATION


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To establish, monitor, and record “quality” for all aspects of the

production, quality control and quality assurance.

A reliable evidence for GMP compliance.

OBJECTIVE OF DOCUMENTATION


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Clearly written documentation prevents errors

It provides assurance that quality related activities are carried out exactly the way they have been planned and approved

Employees know what to do

Responsibilities and authorities are identified

Forms the basis for improvement

PURPOSE OF DOCUMENTATION


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Documentation is the key to operating a cosmetic company in compliance with GMP requirements.

All the elements, requirements and provisions adopted by cosmetic company for its quality system should be documented in a systematic, orderly and understandable manner in the form of policies and procedures.

Documents should be developed, prepared, approved, reviewed and distributed in a controlled manner.

It should be written in detail and in simple language that can be understood by the user.

QUALITY SYSTEM DOCUMENTATION


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Broadly, all documents relating to quality fall into the following categories should be controlled:

Quality ManualQuality ProceduresSupporting Documents or Work InstructionsQuality RecordsAll levels are integrated to form a comprehensive and

cohesive documentation network via a system of cross referencing

Quality Records

Supporting Documents or Work

Instructions

Quality Procedures

Quality Manual

TIERS OF DOCUMENTATION (1)


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26

WORKINSTRUCTIONS

WI #03

WORKINSTRUCTIONS

WI #02

WORKINSTRUCTIONS

WI #01 WORKPROTOCOLS

WP #03

PWORKPROTOCOLS

WP #02

WORKPROTOCOLS

WP #01 STANDARDTEST/

SPECIFICATION

STD #03

STANDARDTEST/

SPECIFICATION

STD #02

STANDARDTESTS /

SPECIFICATION

STD #01 CODE ETIK / WORKPOLICY

CE #03

CODE ETIK / WORKPOLICY

CE #02

CODE ETHIC / WORK POLICY

CE #01

QUALITYMANUAL

QM

LABELIDENTITAS

IL #03

LABELIDENTITAS

IL #02

IDENTITYLABELS

IL #01

QUALITYSTANDARD PROCEDURE

QSP #03

QUALITYSTANDARDPROCEDURE

QSP #02

QUALITYSTANDARD PROCEDURE

QSP #01

TIERS OF DOCUMENTATION (2)


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Quality Records


Instructions

Quality Procedures

Quality Manual

The strategic document that outlines the organization’s system of providing quality assurance to achieve

customer satisfaction.The Quality Manual could be in one document supported by several tiers of document, each becoming progressively more detailed.

The Quality Manual should define the policy of the company, the organisational stru

cture, functions, responsibilities, procedures, instructions, process

es and resources for implementi ng the quality management.

QUALITY MANUAL


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Quality Records


Instructions

Quality Procedure

s

Quality Manual

The tactical document that outlines the activities or operations of the organization in implementing the

stated quality policies.The Quality Procedures should

ensure that if necessary, samples o f starting materials, intermediate,

and finished products are taken, te sted to determine their release or

rejection on the basis of test result s and other available evidence rela

ted to quality.

The quality procedures are needed to enable every employee to work individually and collectively to achieve the organization’s quality objectives.

QUALITY PROCEDURES


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The Working Instruction shoul d describe step by step

instruction specific to a process and machine, specifying the tools, workmanship criteria, tolerance, and direction for the process.

The working instructions is the easy guide for the operator to confirm each step in executing a task.

The working instructions are needed to guide the staff in performing a specific function or task.

Quality Records


Instructions

Quality Procedures

Quality Manual

The operational document containing instructions The operational document containing instructions specifying how the activities are performed or products specifying how the activities are performed or products

are accepted.are accepted.

WORK INSTRUCTION


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conformance to specific requirements;the effective operation of the quality system

All Quality Records should be :Legible and clearDatedReadily identifiable and retrievableCarry authorization statusRetained for a designated periodProtected from damage, light and deterioration while storage

Quality Records


Instructions

Quality Procedures

Quality Manual

Quality Records refer to results as well as charts and data pertaining to activities performed such inspection,

testing, survey, audit, review, etc. They should be maintained as important evidence to demonstrate :

QUALITY RECORD


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Quality Records

Supporting Documents or

Work Instructions

Quality Procedures

Quality Manual

Main Points for Consideration

ESTABLISHMENT OF

QUALITY MANUAL


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1. This Quality Manual should state the company’s commitment to quality and describe the quality system of an organization .

2.Quality System refers to the appropriate infrastructure encompassing Procedures, Processes and Resources. Included in the Quality Manual shall be a clearly defined and

documented quality policy statement that states the company’s commitment to produce safe and quality products and its responsibility to its customers.

The company’s senior management shall demonstrate commitment to the implementation of the Company Quality Policy by signing off the policy.

All supervisory staff and key personnel shall understand and implement the policy.

The quality policy shall be communicated to all staff of the company and regularly reviewed.

QUALITY MANUAL DESCRIPTION (1)


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Top management shall establish its quality policy and ensure that it :

is appropriate for the needs of the organization and its customers;

includes commitment to meeting requirements and continual improvement;

provide a framework for establishing and reviewing quality objectives;

is communicated, understood and implemented throughout the organization;

is reviewed for continuing suitability.



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It is a formal declaration by the company of how it conducts its business with respect to the achievement and assurance of quality.

It is a documented set of managerial instruction on quality matters.

It should describe the organization structure and define clear job description of key employees.

The Quality Manual should be readily available to relevant staff.

The company’s management shall regularly review its quality system to ensure continued effectiveness and suitability.



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Quality manual can be prepared according to ISO prescribed format if it does incorporate the GMP principles or it should contain the following features :

Title and Scope – which company sites and operations are covered?Example:• This manual describes the quality arrangements for

manufacturing process starting from receiving of starting materials to delivery of finished products which are manufactured at :

1 Sembawang AvenueSingapore 123456

• This manual describes the policies and summaries of the quality management system established.

PREPARATION OF A QUALITY MANUAL


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Amendment/Revision History A list of amendment identifiable by version number, date and a title or description of change E.g.

Content PageDistribution list Quality Policy Statement History /Background of the Company

Change in company’s name

18 June 2000QM – GMP / 002

Change of job description of QC i/c (Para 1.5)

1 March 1999QM – GMP / 001

Reasons for RevisionDate of RevisionRef. No.



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Management Organisation There should be a person named as management representative for ensuring the implementation of QM. This person should be appointed by senior management to represent the management authority and to monitor the systemCompany organisational structure, authority, responsibilities and functions

Control of Manual review and revision to ensure relevancy and accuracydistributionwhose responsibilities for the control of manual



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Quality Management System ContentsDescribe how the quality management system works relating to1. Personnel 8. Internal Audit 2. Premises 9. Storage3. Equipment 10. Contract Manufacturing &4. Sanitation & Hygiene Analysis 5. Production 11. Product Complaint6. Quality Control 12. Product Recall7. Documentation

It is important to draw attention to the specific use of formally written and established procedures.Reference may be in the form of table appended to the manualIt should contain only the management policies which govern the application of procedures.It is not normally sensible to include the technical procedures. They should be referred to specifically by title and reference number when appropriate.



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Quick Checklist for a Quality ManualDoes it define the scope of the Quality Management System that it operates?Is it a controlled document?Is there an authorised management representative?Are the organisation structure and control system described and documented?



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Specify the company’s policies on :a. Criteria of staff involved in the manufacturing

activitiesb. Assuring staff’s competency in their workc. Assuring staff’s understanding of procedures,

work instruction, GMP principles , etcd. Assuring that there is no ambiguity of staff’s

roles and responsibilitiese. Staff resources allocationf. Authority of QC and Production



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Specify the requirements of location, design , constructions and maintenance of manufacturing premises with respect to the following:a. prevention of contamination from surrounding

environment and pestsb. prevention of mix up of materials and productsc. facilities such as toilet, changing rooms,

sampling areas and QC labd. defined areas for certain activitiese. wall, ceiling, drains , air intake and exhaust,

lighting and ventilation, pipe work and light fitting

f. storage areas

QUALITY MANUAL CONTENT

PREMISES


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Describe the requirements of the design, installation and maintenance of the equipment and its support system such as ventilation system.


EQUIPMENT


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Describe the sanitation and hygiene practices to avoid contamination of the manufacturing of products with respect to :

a. health condition of the staff; b. good personal hygiene; c. avoid direct physical contact with

product;d. restricted activities within controlled

areas;e. measures to prevent contamination by

staff


SANITATION & HYGIENE


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Describe the control of manufacturing process with respect to the following :

a. Checking and verification of starting materials (r.m., p.m., and water)

b. Traceability of starting materials to the product

a. Handling of rejected materials b. Batch numbering systemc. Weighing and measurementd. Production process of dry and wet

products e. Labeling and packagingf. Finished product: Quarantine and

Delivery


PRODUCTION


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Describe how QC ensures products contain the correct materials of specified quality and quantity and are manufactured under proper conditions.

Describe the QC requirement on the following:a. Samplingb. Inspectingc. Testing d. Environmental monitoring programmee. Review of batch documentationf. Sample retention programmeg. Stability studiesh. Maintenance of material or product

specification i. Reprocessingj. Returned products


QUALITY CONTROL


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Describe the documentation control system with respect to the following:a. Documentation structure (e.g. Quality Manual, Quality

Procedures, Instructions and Records)b. Format requirement for different types of documentsc. Numbering and reference systemd. Handling of controlled and uncontrolled documentse. Handling of obsolete versionsf. Preparation, approval, distribution of documentsg. Review and change control h. Documentation controlleri. Storage of master documentsj. Retention period for recordsk. List of controlled documents


DOCUMENTATION


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Describe the policies related to Internal Audits a. Audit team b. Frequency of auditc. Follow up actions d. Who will be overall responsible for

organising the internal audit


INTERNAL AUDIT


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Specify the requirements concerning storage of materials/ products with respect to the followinga. Space, design, security and cleanlinessb. Storage of quarantine stocksc. Storage of hazardous substancesd. Conditions of storage area

(e.g. temperature & relative humidity)e. Receiving of incoming materialsf. Stock control (e.g. FIFO principle, proper

labeling on the container)


STORAGE


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Describe the systems for handling product complaints with respect to the following:

The designated person responsible for handling complaints Authorised person who will decide on the measures to be takenInvestigationCorrective and Preventive ActionsReview of reportNotification to Authority


PRODUCT COMPLAINT


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Describe the systems for recalling from the market of products known or suspected to be defective:

The designated person responsible for coordinationClassification of product recall Provision of sufficient resourcesMaintenance of Distribution recordsProgress report and final report with reconciliation


PRODUCT RECALL


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SUMMARY QUALITY MANAGEMENT

QA

GMP

QC


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Quality Records


Instructions

Quality Procedures

Quality Manual

SUMMARY QUALITY DOCUMENTATION


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SUMMARY GMPPersonnel

Premise

Equipment

Sanitation & Hygiene

Production

Quality ControlDocumentation

Internal Audit

Storage

Complaints

Product Recall

Contract Manufacturin

g& Analysis

RECALL


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• Title & Version Number• Table of Content• Introduction of the Company• Quality Policy Statement• Scope• Organisation Structure/ Responsibilities of key

personnel• Abbreviation of terms• Management Representative• Revision History• Quality and Management Objectives & Policies• Reference of procedure list• Controlled document• Document Approval Information • Circulation List

SUMMARY QUALITY MANUAL


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RELATED HYPERLINK DOCUMENTS

Trainer manual of Quality Manual An Example of Quality Manual An Example of Quality Manual

Checking List


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1. ASEAN Guidelines for Cosmetic GMP (2003)

2. WHO Guide on GMP: Main Principles for Pharmaceutical Products (2005)

3. PIC/S Guide to GMP for Medicinal Products (2003)

4. ISO 9000:2000 Standards

5. Malaysian GMP for Cosmetic, by Ahmad S.H. and Ibrahim M.L. (2004)

6. Theory and Practice of GMP, by Bennoson M (2002)

REFERENCESREFERENCES


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Thank you for Your KindAttention

ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM

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