Project co-financed by

European Union Project co- financed

by Asean

ASEAN GMP TRAINING MODULE

QUALITY MANAGEMENT SYSTEM
Prepared by
Hui Foong Mei – Singapore
Vongsavanh Insixiengmay – Laos PDR
Davong Oumavong – Laos PDR

Approved by
ASEAN Cosmetic GMP Team

Endorsed by
ASEAN Cosmetic Committee
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CONTENT OF PRESENTATION
1. Basic Principles of Quality Management
a. Basic Principles of Quality Assurance
b. Basic Requirements of Quality Assurance
c. Basic Principles of GMP
d. Basic Requirements of GMP
e. Basic Principles of Quality Control
f. Basic Requirements of Quality Control
2. Basic Principle of Quality Documentation
3. Establishment of Quality Manual

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OBJECTIVES
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
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BASIC
PRINCIPLE OF
QUALITY
MANAGEMENT

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BASIC PRINCIPLE OF by Asean

QUALITY MANAGEMENT (1)

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.

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BASIC PRINCIPLE OF by Asean

QUALITY MANAGEMENT (2)

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 personnel
suitable and sufficient premises,
equipment and facilities

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BASIC PRINCIPLE OF by Asean

QUALITY ASSURANCE (1)

 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.
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BASIC REQUIREMENTS OF by Asean

QUALITY ASSURANCE (1)

 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. STATEMENT
OF
RIGHTS
 Ensure that production and control operations are &
RESPONSIBILITIES
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.

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BASIC REQUIREMENTS OF by Asean

QUALITY ASSURANCE (2)

 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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BASIC PRINCIPLES OF by Asean

GOOD MANUFACURING PRACTICES

 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.
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BASIC PRINCIPLES OF by Asean

GOOD MANUFACURING PRACTICES (1)

All manufacturing process are clearly
defined and systematically reviewed.
All necessary facilities/resources for
GMP should be provided :
adequate, qualified and well-trained
personnel
suitable premises and sufficient space
suitable location
good personal hygiene and proper
sanitation
suitable equipment and services
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BASIC PRINCIPLES OF by Asean

GOOD MANUFACURING PRACTICES (2)

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
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BASIC PRINCIPLES OF by Asean

QUALITY CONTROL (1)

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.
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SCOPE OF QC

Items concerned :
Starting materials
Packaging materials
Bulk products
Intermediate and finished products
Environmental conditions

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BASIC REQUIREMENTS OF by Asean

QUALITY CONTROL (1)

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.

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BASIC REQUIREMENTS OF by Asean

QUALITY CONTROL (2)

 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
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OTHER DUTIES OF QC

Establish QC procedures
Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring

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QUALITY CONTROL ASSESSMENT OF by Asean

MANUFACTURING ACTIVITY
Should include the following:
Production conditions
In process quality control activity
Manufacturing documentation
Compliance with finished product specification
Examination of the finished products

QC Access
QC personnel MUST have access to production
area for sampling and investigation
Access to QC lab is strictly for QC personnel

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QUALITY CONTROL ACTIVITIES

QC should cover the following:
a. Sampling
b. Specification
c. Testing
d. Release procedures
e. Recalls and complaints
f. Decision making in all quality matters
g. Definition of product quality
h. Laboratory operations
i. Release authorisation
j. Investigation and reporting
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QUALITY RELATIONSHIP

Quality Management

Quality Assurance

G.M.P.

Quality Control
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BASIC PRINCIPLE OF
DOCUMENTATION

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OBJECTIVE OF DOCUMENTATION

A reliable evidence for GMP compliance.

To establish, monitor, and record “quality”

for all aspects of the production, quality
control and quality assurance.

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PURPOSE OF DOCUMENTATION
 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

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QUALITY SYSTEM DOCUMENTATION

 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.
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TIERS OF DOCUMENTATION (1)

Quality Broadly, all documents
Manual
relating to quality fall into
Quality the following categories
Procedures
should be controlled:
Supporting Documents Quality Manual
or Work Instructions
Quality Procedures
Supporting Documents
Quality Records or Work Instructions
Quality Records
All levels are integrated to form a comprehensive and cohesive
documentation network via a system of cross referencing
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TIERS OF DOCUMENTATION (2)

QM
QUALITY
MANUAL

QSP #03
QUALITY
QSP #02
STANDARD
QUALITY
QSP #01
PROCEDURE
QUALITY
STANDARD
STANDARD
PROCEDURE
PROCEDURE

WI #03 WP #03 STD #03 CE #03 IL #03

WI #02 WP #02 STD #02 CE #02 IL #02
WI #01
WORK WP #01
WORK STD #01
STANDARD CE #01
CODE ETIK / LABEL
IL #01
INSTRUCTIONS PROTOCOLS TEST/ WORK IDENTITAS
LABEL
WORK PWORK STANDARD
STANDARD CODE ETIK /
INSTRUCTIONS SPECIFICATION
TEST/ POLICY
WORK IDENTITAS
IDENTITY
WORK PROTOCOLS
WORK TESTS / CODE ETHIC /
INSTRUCTIONS PROTOCOLS SPECIFICATION POLICY
WORK POLICY LABELS
SPECIFICATION

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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

Quality
Manual one document supported by several
tiers of document, each becoming
Quality progressively more detailed.
Procedures
The Quality Manual should define
Supporting Documents the policy of the company, the organ
or Work Instructions isational structure, functions, respons
ibilities, procedures, instructions, pro
cesses and resources for implementi
Quality Records ng the quality management.

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QUALITY PROCEDURES
The tactical document that outlines the activities or operations
of the organization in implementing the stated quality policies.
The Quality Procedures should ensu
Quality re that if necessary, samples of starting
Manual materials, intermediate, and finished pr
oducts are taken, tested to determine
Quality
their release or rejection on the basis o
Procedures f test results and other available eviden
Supporting Documents ce related to quality.
or Work Instructions
The quality procedures are needed to
enable every employee to work
Quality Records individually and collectively to achieve
the organization’s quality objectives.

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WORK INSTRUCTION
The operational document containing instructions specifying
how the activities are performed or products are accepted.
The Working Instruction should
Quality describe step by step instruction
Manual specific to a process and machine,
specifying the tools, workmanship
Quality
Procedures criteria, tolerance, and direction for
the process.
Supporting Documents The working instructions is the easy
or Work Instructions guide for the operator to confirm each
step in executing a task.

Quality Records
The working instructions are needed
to guide the staff in performing a
specific function or task.
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QUALITY RECORD
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 :
conformance to specific
Quality
Manual
requirements;
the effective operation of the
Quality quality system
Procedures

All Quality Records should be :

Supporting Documents Legible and clear
or Work Instructions
Dated
Readily identifiable and retrievable
Carry authorization status
Retained for a designated period
Quality Records Protected from damage, light and
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ESTABLISHMENT OF by Asean

QUALITY MANUAL
Quality
Manual

Quality Main Points for

Procedures
Consideration
Supporting Documents
or Work Instructions

Quality Records

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QUALITY MANUAL DESCRIPTION (1)

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.

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QUALITY MANUAL DESCRIPTION (2)

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 continuingModule

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QUALITY MANUAL DESCRIPTION (3)

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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PREPARATION OF A QUALITY MANUAL

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 Avenue
Singapore 123456
• This manual describes the policies and summaries of the quality
management system established.

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PREPARATION OF A QUALITY MANUAL

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

Ref. No. Date of Revision Reasons for Revision

QM – GMP / 001 1 March 1999 Change of job description
of QC i/c (Para 1.5)
QM – GMP / 002 18 June 2000 Change in company’s name

Content Page
Distribution list
Quality Policy Statement
History /Background of the Company
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PREPARATION OF A QUALITY MANUAL

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
system
Company organisational structure, authority, responsibilities
and functions

Control of Manual
review and revision to ensure relevancy and accuracy
distribution
whose responsibilities for the control of manual

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PREPARATION OF A QUALITY MANUAL

Quality Management System Contents
Describe how the quality management system works relating to
1. Personnel 8. Internal Audit
2. Premises 9. Storage
3. Equipment 10. Contract Manufacturing &
4. Sanitation & Hygiene Analysis
5. Production 11. Product Complaint
6. Quality Control 12. Product Recall
7. 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 manual
It 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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PREPARATION OF A QUALITY MANUAL

Quick Checklist for a Quality Manual

Does 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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PREPARATION OF A QUALITY MANUAL

Specify the company’s policies on :
a. Criteria of staff involved in the manufacturing
activities
b. Assuring staff’s competency in their work
c. Assuring staff’s understanding of procedures, work
instruction, GMP principles , etc
d. Assuring that there is no ambiguity of staff’s roles
and responsibilities
e. Staff resources allocation
f. Authority of QC and Production

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PREMISES
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 pests
b. prevention of mix up of materials and products
c. facilities such as toilet, changing rooms, sampling
areas and QC lab
d. defined areas for certain activities
e. wall, ceiling, drains , air intake and exhaust, lighting
and ventilation, pipe work and light fitting
f. storage areas
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EQUIPMENT

Describe the requirements of

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

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SANITATION & HYGIENE

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

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PRODUCTION
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 system
c. Weighing and measurement
d. Production process of dry and wet products
e. Labeling and packaging
f. Finished product: Quarantine and Delivery

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QUALITY CONTROL
 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. Sampling
b. Inspecting
c. Testing
d. Environmental monitoring programme
e. Review of batch documentation
f. Sample retention programme
g. Stability studies
h. Maintenance of material or product specification
i. Reprocessing
j. Returned products
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DOCUMENTATION

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 documents
c. Numbering and reference system
d. Handling of controlled and uncontrolled documents
e. Handling of obsolete versions
f. Preparation, approval, distribution of documents
g. Review and change control
h. Documentation controller
i. Storage of master documents
j. Retention period for records
k. List of controlled documents
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INTERNAL AUDIT

Describe the policies related to

Internal Audits
a. Audit team
b. Frequency of audit
c. Follow up actions
d. Who will be overall responsible for
organising the internal audit

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STORAGE

Specify the requirements concerning storage of

materials/ products with respect to the following
a. Space, design, security and cleanliness
b. Storage of quarantine stocks
c. Storage of hazardous substances
d. Conditions of storage area
(e.g. temperature & relative humidity)
e. Receiving of incoming materials
f. Stock control (e.g. FIFO principle, proper
labeling on the container)

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PRODUCT COMPLAINT

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 taken
Investigation
Corrective and Preventive Actions
Review of report
Notification to Authority

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PRODUCT RECALL

Describe the systems for recalling from the

market of products known or suspected to be
defective:
The designated person responsible for coordination
Classification of product recall
Provision of sufficient resources
Maintenance of Distribution records
Progress report and final report with
reconciliation

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SUMMARY QUALITY MANAGEMENT

QA

GMP

QC

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SUMMARY QUALITY DOCUMENTATION

Quality
Manual

Quality
Procedures

Supporting Documents
or Work Instructions

Quality Records

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SUMMARY GMP
Product Recall Personnel
L
C AL
RE
Complaints Premise

Contract
Manufacturing Equipment
& Analysis

Storage Sanitation
& Hygiene

Internal Audit Production

Documentation Quality Control

European Committee Module 1

for Standardization GMP Workshop Kuala Lumpur 14-16 54
Implementing Agency
November
Project co-financed by
European Union Project co- financed
by Asean

SUMMARY QUALITY MANUAL

 
• 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
European Committee Module 1
for Standardization GMP Workshop Kuala Lumpur 14-16 55
Implementing Agency
November
Project co-financed by
European Union Project co- financed
by Asean

RELATED HYPERLINK DOCUMENTS

 Trainer manual of Quality Manual

 An Example of Quality Manual
 An Example of Quality Manual Checking List

European Committee Module 1

for Standardization GMP Workshop Kuala Lumpur 14-16 56
Implementing Agency
November
Project co-financed by
European Union Project co- financed

REFERENCES
by Asean

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)

European Committee Module 1

for Standardization GMP Workshop Kuala Lumpur 14-16 57
Implementing Agency
November
Project co-financed by
European Union Project co- financed
by Asean

Thank you
for
Your Kind
Attention

European Committee Module 1

for Standardization GMP Workshop Kuala Lumpur 14-16 58
Implementing Agency
November