01 Quality Management System

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
European Committee Module 1
for Standardization
Implementing Agency GMP Workshop Kuala Lumpur 14-16 November 2005 1
CONTENT OF PRESENTATION
by Asean
1. Basic Principles of Quality Management System

(QMS)
a. Basic Principles of Quality Assurance (QA)
b. Basic Requirements of QA
c. Basic Principles of Good Manufacturing Practices
(GMP)
d. Basic Requirements of GMP
e. Basic Principles of Quality Control (QC)
f. Basic Requirements of QC
g. Basic Functions of QC
2. Establishment of a QMS in the Organization
3. Basic Principles of Quality Documentation
4. Preparation and development of the Quality
Manual

for Standardization
Implementing Agency GMP Workshop Kuala Lumpur 14-16 November 2
by Asean
OBJECTIVES
 To understand key concepts of quality
management, quality assurance, GMP
and quality control.
 To understand hierarchy of quality
documentation.
 To understand specific requirements on
of the quality manual.
 To develop quality manual based on GMP
requirements.
for Standardization
by Asean
BASIC
PRINCIPLES OF
QUALITY
MANAGEMENT
SYSTEM

for Standardization
by Asean
BASIC PRINCIPLES OF
QUALITY MANAGEMENT SYSTEM
 Manufacturer shall ensure the cosmetic products comply
with the requirements of ASEAN Cosmetic Directives (ACD).
 They shall also comply with any other applicable regulations
pertaining to your specific country.
 The attainment of this quality objective shall be led by the
senior management and requires the participation and
commitment of staff and extended to the, company’s
suppliers, distributors, and toll manufacturers.

for Standardization
by Asean
BASIC PRINCIPLES OF
QUALITY MANAGEMENT SYSTEM (cont.)
 To achieve the quality objective, there shall be a comprehensive
QMS incorporating GMP.
 The QMS shall be fully documented and its effectiveness shall
be monitored.
 All parts of QMS shall have:
adequate competent personnel.
suitable and sufficient premises, equipment
and facilities.

for Standardization
QUALITY MANAGEMENT
by Asean
SYSTEM
QMS 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

for Standardization
by Asean
BASIC PRINCIPLES OF
QUALITY ASSURANCE
 Quality Assurance refers to administrative and procedural
activities implemented in a quality system so that requirements
and goals for a product, service or activity will be fulfilled.
 QA covers all aspects of GMP and QC processes and its activities
are organized with an aim to ensure the products are of the
required quality.
 QA includes management of the quality of starting materials,
assemblies, products and components, services related to
production, and management, production and inspection
processes

for Standardization
BASIC REQUIREMENTS OF by Asean
QUALITY ASSURANCE (cont.)

 Ensure that products are designed and developed based on
sound scientific rationale which are aligned with Good
Laboratory Practice (GLP) or GMP principles.
 Ensure that managerial responsibilities are clearly specified
and agreed upon.
 Ensure that production and control operations are clearly
specified and agreed upon. STATEMENT
OF
 Ensure the use of approved starting and packaging materials. RIGHTS
&
RESPONSIBILITIES
 Ensure that finished products are correctly processed and
checked and released by authorized person.

for Standardization
BASIC REQUIREMENTS OF by Asean
QUALITY ASSURANCE (cont.)

 Ensure that finished products are stored,
distributed and handled based on Good
Storage Practices (GSP) and GDP.
 Ensure that a mechanism for regular
inspection and internal quality audit is in place
and regularly conducted.

for Standardization
BASIC PRINCIPLES OF by Asean
GOOD MANUFACTURING PRACTICES

 GMP ensures that products are consistently produced and
controlled based on the established quality standards
 GMP minimizes risks on:
• Cross-contamination
• Mix-ups
 GMP ensures that materials and finished products are traceable
to the original source.
 GMP shall build quality into the product.
 Production and quality control functions shall be independent of
each other.

for Standardization
GOOD MANUFACTURING PRACTICES (cont.)
 GMP ensures that all manufacturing processes are clearly

defined and systematically reviewed.
 All necessary facilities and resources for GMP shall be
provided with:
suitable location
suitable premises and adequate space
adequate, qualified and well-trained personnel
appropriate equipment and contracted services
good personal hygiene and proper sanitation

for Standardization
GOOD MANUFACTURING PRACTICES (cont.)

 clearly defined and easily understood manufacturing
processes
 good documentation system
 systematic internal quality audit
 comprehensive corrective action and preventive action
(CAPA) system
 appropriate storage and transport
 proper handling of complaints
 proper product recall system

for Standardization
QUALITY CONTROL
 Quality control, or QC for short, is a process by which entities
review the quality of all factors involved in production.
 QC is part of GMP.
 QC is concerned with sampling, specification and testing.
 Manufacturer shall have a QC department.
 QC shall be headed by a qualified and experienced person.
 QC shall be independent from production and other departments.
 QC ensures that the necessary and relevant tests are actually
carried out.
 QC ensures that all starting materials and finished products shall
be released after their quality had been approved according to
established specifications and standards.

for Standardization
by Asean
SCOPE OF QC
Testing and evaluation of:
 Starting materials,
 Packaging materials,
 Bulk products,
 Intermediate and finished products,
 Environmental conditions
(e.g. Premises, Equipments, etc.)

for Standardization
BASIC FUNCTIONS OF by Asean
QUALITY CONTROL
 QC checks compliance of and approves starting materials, packaging
materials, in-process bulk and finished products with established
specifications.
 QC reviews and evaluates production documentation and records.
 QC assesses process deviations.
 QC collects and maintains appropriate number of reference samples

of starting materials and finished products.

for Standardization
BASIC FUNCTIONS OF by Asean
QUALITY CONTROL (cont.)
 QC establishes testing methods and

procedures.
 QC conducts real-time stability testing
 QC conducts investigations on product
complaints
 QC conducts environmental monitoring.

for Standardization
by Asean
QUALITY CONTROL ACTIVITIES

In summary, QC shall cover the following:
a. Sampling
b. Specification
c. Inspection and Testing
d. Release procedures
e. Investigation and reporting
f. Recalls and complaints
g. Management of the Laboratory testing
equipment and apparatus

for Standardization
by Asean
QUALITY RELATIONSHIP
Quality Management System
Quality Assurance
Good Manufacturing Practices
Quality Control
for Standardization
by Asean
BASIC PRINCIPLES
OF
DOCUMENTATION

for Standardization
by Asean
OBJECTIVE OF DOCUMENTATION
Documentation is a reliable evidence for

GMP compliance.
To establish, monitor, and record “quality”

for all aspects of the production, quality
control and quality assurance.
“IF IT’S NOT WRITTEN, IT IS NOT DONE”

for Standardization
by Asean
PURPOSES OF DOCUMENTATION
 To have a clearly written documentation that
prevents errors
 To provides assurance that quality related
activities are carried out as planned and
approved
 To guide employees on what to do
 To identify authorities and their responsibilities
 To serve as basis for improvement

for Standardization
by Asean
QMS DOCUMENTATION
 Documents shall be written in detail and in simple

language that can be understood by the user.
 All GMP elements, requirements and provisions
adopted by cosmetic company for its quality system
shall be documented in a systematic, orderly and
understandable manner in the form of policies and
procedures.
 Documents shall be developed, prepared, approved,
reviewed and distributed in a controlled manner.

for Standardization
by Asean
TIERS OF DOCUMENTATION
Broadly, all documents
Quality
Manual relating to quality fall into
the following categories
Quality
Procedures shall be controlled:
 Quality Manual
Work Instructions
 Quality Procedures
 Work Instructions
 Quality Records and
Quality Records and Supporting
Documents Supporting Documents
All levels are integrated to form a comprehensive and cohesive

documentation network via a system of cross referencing
for Standardization
by Asean
TIERS OF DOCUMENTATION (cont.)

QM
QUALITY
MANUAL
QSP #03
QUALITY
QSP #02
STANDARD
QSP #01
QUALITY
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 CODECE #01/ WORK
ETIK ILLABEL
#01
INSTRUCTIONS PROTOCOLS STANDARD
TEST/ POLICY IDENTITAS
LABEL
WORK PWORK STANDARD CODE ETIK / WORK
TEST/
SPECIFICATION IDENTITAS
IDENTITY
INSTRUCTIONS
WORK WORK
PROTOCOLS TESTS / POLICY
CODE ETHIC /
SPECIFICATION LABELS
INSTRUCTIONS PROTOCOLS SPECIFICATION WORK POLICY
European Committee Module 1 25

for Standardization
by Asean
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
Quality document, each becoming progressively
Manual
more detailed.
Quality The Quality Manual shall define the policy of

Procedures
the company, the organisational structure,
functions, responsibilities, procedures,
Work Instructions instructions, processes and resources for
implementing the quality management.

Documents

for Standardization
by Asean
QUALITY PROCEDURES
The tactical document that outlines the activities or operations
of the organization in implementing the stated quality policies.
The Quality Procedures shall ensure
Quality that if necessary, samples of starting
Manual materials, intermediate, and finished
products are taken, tested to
Quality
determine their release or rejection on
Procedures the basis of test results and other
Work Instructions available evidence related to quality.
The quality procedures are needed to

enable every employee to work
Quality Records and Supporting individually and collectively to achieve
Documents the organization’s quality objectives.

for Standardization
by Asean
WORK INSTRUCTIONS
The document containing operational instructions specifying
how the activities are performed or products are accepted.
The Work Instructions shall describe step

by step operational process specific to a
Quality
Manual machine and equipment,, the workmanship
criteria, its tolerance levels, and direction of
Quality the process.
Procedures
The work instructions serves as a guide for
the staff or operator to confirm each step in
Work Instructions executing a specific function or task.

Documents

for Standardization
European Union
QUALITY RECORDS AND Project co- financed
by Asean
SUPPORTING DOCUMENTS
Quality Records refer to results such as reports, charts and data
pertaining to activities performed during the inspection, testing,
survey, audit, review, etc. They shall be maintained as important
evidence to demonstrate :
 the conformance to specific
requirements;
Quality  the effectiveness of the
Manual
operation of the quality system.
Quality
Procedures All Quality Records shall be :
Legible and clear
Dated
Work Instructions
Readily identifiable and retrievable
Retained for a designated period
Protected from damage, light and
deterioration while storage
Quality Records and Signed and dated by authorized
Supporting Documents person/s
for Standardization
Project co- financed
ESTABLISHMENT OF
European Union
by Asean
QUALITY MANUAL
Quality
Manual
Quality M ain P oints for

Consideration
Procedures
Work Instructions
Quality Records and

Supporting Documents

for Standardization
QUALITY MANUAL DESCRIPTION

by Asean
1. The Quality Manual shall include the following:

Statement of the com pany’s com m itm ent to quality and describe its Quality
Management System.
 Included in the Quality Manual shall be a clearly defined and documented

quality policy statem ent 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.

for Standardization
MAIN POINTS FOR CONSIDERATION

by Asean
(QUALITY MANUAL)
 It is a form al declaration by the company on how it conducts
its business with respect to the achievement and assurance of
quality.
 It shall describe the organization’s structure, defined job
descriptions of key employees.
 It is a set of documents of managerial instructions on quality
matters.
 The Quality Manual shall be readily available to relevant staff.
 The company’s management shall regularly review its quality
system to ensure continued effectiveness and suitability.

for Standardization
by Asean
PREPARATION OF A QUALITY MANUAL

Quality manual can be prepared based on a preferred format and shall
contain the following:
 Title and Scope

Example: (Sample Quality Manual); ((Checklist for QM))

for Standardization
by Asean
PREPARATION OF A QUALITY MANUAL (cont.)

 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
for Standardization
by Asean
 Management Organisation
There shall be a person named as management
representative for ensuring the implementation of QM. This
person shall be appointed by senior management to
represent the management authority and to monitor the
system.
Company’s organisational structure, authorities,
responsibilities and functions.
 Control of Manual
Review and revision to ensure relevancy and accuracy
Distribution of copies
Person responsible for the control of the manual
for Standardization
by Asean

 Quality Manual contains:
Descriptions 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 shall contain the management policies which govern the
application of procedures.

for Standardization
by Asean
 Quick Checklist for a Quality Manual (see

checklist)
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?

for Standardization
by Asean

Specify the company’s policies on :
a. Criteria of staff involved in the manufacturing
activities.
b. Competency of staff in their work
c. Understanding of staff of procedures, work
instruction, GMP principles , etc
d. Allocation of staff

for Standardization
QUALITY MANUAL CONTENT by Asean
PREMISES
Specify the requirements of location, design, constructions
and maintenance of manufacturing premises with respect
to the following:
a. prevention of contamination from environment and
pests.
b. prevention of mix-up of materials and products.
c. facilities such as toilet, changing rooms, sampling
areas and QC laboratory.
d. defined areas for certain activities.
e. wall, ceiling, drains , air intake and exhaust, lighting,
ventilation, and pipe work and light fitting.

for Standardization
EQUIPMENT
Describe the requirements of

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

for Standardization
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.

for Standardization
PRODUCTION
Describe the control of manufacturing process with
respect to the following :
a. Checking and verification of starting materials (raw
materials, packaging materials 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/or wet products.
e. Labeling and packaging.
f. Finished product: Quarantine and Delivery.

for Standardization
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
for Standardization
DOCUMENTATION
Describe the documentation control system with respect
to the following:
a. Documentation structure (e.g. Quality Manual, Quality
Procedures, Work Instructions and Quality Records and
Supporting Documents),
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 copies of documents,
g. Review and change control,
h. Documentation controller,
i. Storage of master documents,
j. Retention period for records,

for Standardization
INTERNAL QUALITY AUDIT

Describe the policies related to
Internal Audits
a. Composition of the audit team
b. Frequency of audit
c. Conduct of audit and reporting
d. Follow up actions
e. Responsibility of top management

for Standardization
STORAGE
Specify the requirements concerning storage areas with
respect to the following:
a. Space, design, security and cleanliness.
b. Quarantined stocks, approved, rejected and returned materials
and products.
c. Toxic/flammable/hazardous substances.
d. Conditions of storage area/s (e.g. temperature & relative
humidity).
e. Receiving and releasing of materials and products including
stock control processes (e.g. FIFO/FEFO principle, inventory,
proper labeling on the container).

for Standardization
PRODUCT COMPLAINT
Describe the systems for handling product complaints
with respect to the following:
 Person responsible for handling complaints
 Authorised person who will decide on the measures to be
taken
 Conduct of investigation, report writing and review
 Corrective and Preventive Actions
 Feedback to complainant
 Report to Authority when applicable

for Standardization
PRODUCT RECALL
Describe the systems for recalling from the market of
products known or suspected to be defective:
 Person responsible for handling coordination of product recall.
 Classification and level of product recall.
 Handling of product recall.
 Review and maintenance of Distribution records.
 Progress report and final report with reconciliation.

for Standardization
European Union SUMMARY QUALITY MANAGEMENT SYSTEM Project co- financed
by Asean
QMS
QA
GMP
QC

for Standardization
by Asean
SUMMARY QUALITY DOCUMENTATION
Quality
Manual
Quality
Procedures
Work Instructions
Quality Records and supporting

documents

for Standardization
by Asean
GMP SUMMARY
Product Recall Personnel
Complaints Premises
Contract
Manufacturing Equipment
& Analysis
Storage Sanitation
& Hygiene
Internal Quality Production

Audit
Documentation Quality Control

for Standardization
by Asean
QUALITY MANUAL SUMMARY
• 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
for Standardization
by Asean
RELATED HYPERLINK DOCUMENTS
 Trainer manual of Quality Manual

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

for Standardization
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)

for Standardization
by Asean
Thank you
for
Your Kind
Attention

for Standardization

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Project co-financed by

European Union Project co- financed

ASEAN GMP TRAINING MODULE

1. Basic Principles of Quality Management System

European Committee Module 1

European Committee Module 1

European Committee Module 1

European Committee Module 1

1. Personnel 8. Internal Audit

6. Quality Control 12. Product Recall

European Committee Module 1

European Committee Module 1

BASIC REQUIREMENTS OF by Asean

QUALITY ASSURANCE (cont.)

European Committee Module 1

BASIC REQUIREMENTS OF by Asean

QUALITY ASSURANCE (cont.)

European Committee Module 1

BASIC PRINCIPLES OF by Asean

GOOD MANUFACTURING PRACTICES

European Committee Module 1

BASIC PRINCIPLES OF by Asean

GOOD MANUFACTURING PRACTICES (cont.)

 GMP ensures that all manufacturing processes are clearly

European Committee Module 1

BASIC PRINCIPLES OF by Asean

GOOD MANUFACTURING PRACTICES (cont.)

European Committee Module 1

BASIC PRINCIPLES OF by Asean

European Committee Module 1

European Committee Module 1

BASIC FUNCTIONS OF by Asean

 QC reviews and evaluates production documentation and records.

 QC assesses process deviations.

 QC collects and maintains appropriate number of reference samples

European Committee Module 1

BASIC FUNCTIONS OF by Asean

QUALITY CONTROL (cont.)

 QC establishes testing methods and

European Committee Module 1

QUALITY CONTROL ACTIVITIES

European Committee Module 1

Quality Management System

Good Manufacturing Practices

European Committee Module 1

Documentation is a reliable evidence for

To establish, monitor, and record “quality”

European Committee Module 1

European Committee Module 1

 Documents shall be written in detail and in simple

European Committee Module 1

All levels are integrated to form a comprehensive and cohesive

TIERS OF DOCUMENTATION (cont.)

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

European Committee Module 1 25

The Quality Manual could be in one

Quality The Quality Manual shall define the policy of

Quality Records and Supporting

European Committee Module 1

The quality procedures are needed to

European Committee Module 1

The Work Instructions shall describe step

Quality Records and Supporting