1. Quality Systems Approach
What is a Quality System?
Commitment to Quality by the Organization
To and By Management to a WRITTEN quality program
To an appropriate organizational structure to insure product quality and safety
To Manufacturing for proper resources, facility, equipment, the organization’s structure, staff, and training to do things right the first time
To manage a program of continuous improvement including internal assessments and initiation of necessary corrective action
Where is it found?
What does it do?
Who does it affect?
When does it start?

2. 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
Complaint handling is defined in the ASEAN Cosmetic GMP. One necessary but not always pleasant aspect of quality management is dealing with complaints.

3. CONTENT OF PRESENTATION
Basic Principles of Quality Management
Basic Principles of Quality Assurance
Basic Requirements of Quality Assurance
Basic Principles of GMP
Basic Requirements of GMP
Basic Principles of Quality Control
Basic Requirements of Quality Control
Basic Principle of Quality Documentation
Establishment of Quality Manual
Content of presentation describes in 4 section :
Introduction
Objectives
Scope
Definition
Basic principle of product complaints
Product complaint principles
Role of manufacturer
Complaint handling principles
Complaint handling principle
Responsible person
Complaint handling procedure
Investigation
Investigation records
Remedial Action
Response
Decision from an investigation
Classification of defects & complaints
Trend review
Documentation
Reporting
Related hyperlink documents
References

4. 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

5. BASIC PRINCIPLE OF QUALITY MANAGEMENT

6. BASIC PRINCIPLE OF
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.

7. BASIC PRINCIPLE OF 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

8. BASIC PRINCIPLE OF 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.

9. QUALITY ASSURANCE (1) BASIC REQUIREMENTS OF
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.
STATEMENT OF
RIGHTS
&
RESPONSIBILITIES

10. BASIC REQUIREMENTS OF
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.

11. GOOD MANUFACURING PRACTICES (1)
BASIC PRINCIPLES OF
GOOD MANUFACURING PRACTICES (1)
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 a not reliable way to assure product quality. Should BUILD quality into the product!
Production and quality control functions should be independent of each other.

12. GOOD MANUFACURING PRACTICES (2)
BASIC PRINCIPLES OF
GOOD MANUFACURING PRACTICES (2)
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

13. GOOD MANUFACURING PRACTICES (3)
BASIC PRINCIPLES OF
GOOD MANUFACURING PRACTICES (3)
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

14. QUALITY CONTROL (1) BASIC PRINCIPLES OF 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.

15. SCOPE OF QC Items concerned : Starting materials Packaging materials
Bulk products
Intermediate and finished products
Environmental conditions

16. BASIC REQUIREMENTS OF
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.

17. BASIC REQUIREMENTS OF
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

18. OTHER DUTIES OF QC Establish QC procedures Manage reference standards
Ensure correct labeling
Stability testing (if applicable)
Complaint investigation
Environmental monitoring

19. MANUFACTURING ACTIVITY
QUALITY CONTROL ASSESSMENT OF
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

20. QUALITY CONTROL ACTIVITIES
QC should cover the following:
Sampling
Specification
Testing
Release procedures
Recalls and complaints
Decision making in all quality matters
Definition of product quality
Laboratory operations
Release authorisation
Investigation and reporting

21. QUALITY RELATIONSHIP Quality Management Quality Assurance G.M.P.
Quality Control

22. BASIC PRINCIPLE OF
DOCUMENTATION

23. 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.

24. 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

25. 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.

26. TIERS OF DOCUMENTATION (1)
Broadly, all documents relating to quality fall into the following categories should be controlled:
Quality Manual
Quality Procedures
Supporting Documents or Work Instructions
Quality Records
Quality Records
Supporting Documents or Work Instructions
Quality Procedures
Quality Manual
All levels are integrated to form a comprehensive and cohesive documentation network via a system of cross referencing

27. TIERS OF DOCUMENTATION (2) CODE ETHIC / WORK POLICYQM
QUALITY
MANUAL
QSP #03
QUALITY
STANDARD PROCEDURE
QUALITY
STANDARD
PROCEDURE
QSP #02
QSP #01
QUALITY
STANDARD PROCEDURE
WI #03
WP #03
STD #03
CE #03
IL #03
WI #02
WP #02
STD #02
STANDARD
TEST/
SPECIFICATION
CE #02
IL #02
WORK
INSTRUCTIONS
WI #01
WORK
PROTOCOLS
WP #01
STANDARD
TEST/ SPECIFICATION
STD #01
CODE ETIK / WORK
POLICY
CE #01
LABEL
IDENTITAS
IL #01
LABEL
IDENTITAS
WORK
INSTRUCTIONS
PWORK
PROTOCOLS
CODE ETIK / WORK
POLICY
STANDARD
TESTS /
SPECIFICATION
WORK
INSTRUCTIONS
WORK
PROTOCOLS
CODE ETHIC / WORK POLICY
IDENTITY
LABELS 27

28. Supporting Documents or Work Instructions
QUALITY MANUAL
The strategic document that outlines the organization’s system of providing quality assurance to achieve customer satisfaction.
Quality Records
Supporting Documents or Work Instructions
Quality Procedures
Quality Manual
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 structure, functions, responsibilities, procedures, instructions, processes and resources for implementing the quality management.

29. Supporting Documents or Work Instructions
QUALITY PROCEDURES
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 of starting materials, intermediate, and finished products are taken, tested to determine their release or rejection on the basis of test results and other available evidence related to quality.
The quality procedures are needed to enable every employee to work individually and collectively to achieve the organization’s quality objectives.
Quality Records
Supporting Documents or Work Instructions
Quality Procedures
Quality Manual

30. Supporting Documents or Work Instructions
The operational document containing instructions specifying how the activities are performed or products are accepted.
The Working Instruction should 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
Supporting Documents or Work Instructions
Quality Procedures
Quality Manual

31. Supporting Documents or Work Instructions
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 :
Quality Records
Supporting Documents or Work Instructions
Quality Procedures
Quality Manual
conformance to specific requirements;
the effective operation of the quality system
All Quality Records should be :
Legible and clear
Dated
Readily identifiable and retrievable
Carry authorization status
Retained for a designated period
Protected from damage, light and deterioration while storage

32. Supporting Documents or Work Instructions
ESTABLISHMENT OF
QUALITY MANUAL
Quality Records
Supporting Documents or Work Instructions
Quality Procedures
Quality Manual
Main Points for Consideration

33. QUALITY MANUAL DESCRIPTION (1)
This Quality Manual should state the company’s commitment to quality and describe the quality system of an organization .
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.

34. 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 continuing suitability.

35. 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.

36. 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
This manual describes the policies and summaries of the quality management system established.

37. 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.
Content Page
Distribution list
Quality Policy Statement
History /Background of the Company
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

38. 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

39. PREPARATION OF A QUALITY MANUAL
Quality Management System Contents
Describe how the quality management system works relating to
Personnel  Internal Audit
Premises  Storage
Equipment  Contract Manufacturing &
Sanitation & Hygiene Analysis
Production  Product Complaint
Quality Control  Product Recall
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.

40. 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?

41. PREPARATION OF A QUALITY MANUAL
Specify the company’s policies on :
Criteria of staff involved in the manufacturing activities
Assuring staff’s competency in their work
Assuring staff’s understanding of procedures, work instruction, GMP principles , etc
Assuring that there is no ambiguity of staff’s roles and responsibilities
Staff resources allocation
Authority of QC and Production

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

43. QUALITY MANUAL CONTENT
EQUIPMENT
Describe the requirements of the design, installation and maintenance of the equipment and its support system such as ventilation system.

44. QUALITY MANUAL CONTENT
SANITATION & HYGIENE
Describe the sanitation and hygiene practices to avoid contamination of the manufacturing of products with respect to :
health condition of the staff;
good personal hygiene;
avoid direct physical contact with product;
restricted activities within controlled areas;
measures to prevent contamination by staff

45. QUALITY MANUAL CONTENT
PRODUCTION
Describe the control of manufacturing process with respect to the following :
Checking and verification of starting materials (r.m., p.m., and water)
Traceability of starting materials to the
product
Handling of rejected materials
Batch numbering system
Weighing and measurement
Production process of dry and wet products
Labeling and packaging
Finished product: Quarantine and Delivery

46. QUALITY MANUAL CONTENT
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:
Sampling
Inspecting
Testing
Environmental monitoring programme
Review of batch documentation
Sample retention programme
Stability studies
Maintenance of material or product specification
Reprocessing
Returned products

47. QUALITY MANUAL CONTENT
DOCUMENTATION
Describe the documentation control system with respect to the following:
Documentation structure (e.g. Quality Manual, Quality Procedures, Instructions and Records)
Format requirement for different types of documents
Numbering and reference system
Handling of controlled and uncontrolled documents
Handling of obsolete versions
Preparation, approval, distribution of documents
Review and change control
Documentation controller
Storage of master documents
Retention period for records
List of controlled documents

48. Describe the policies related to Internal Audits
QUALITY MANUAL CONTENT
INTERNAL AUDIT
Describe the policies related to Internal Audits
Audit team
Frequency of audit
Follow up actions
Who will be overall responsible for organising the internal audit

49. QUALITY MANUAL CONTENT
STORAGE
Specify the requirements concerning storage of materials/ products with respect to the following
Space, design, security and cleanliness
Storage of quarantine stocks
Storage of hazardous substances
Conditions of storage area (e.g. temperature & relative humidity)
Receiving of incoming materials
Stock control (e.g. FIFO principle, proper labeling on the container)

50. CONTRACT MANUFACTURING & ANALYSIS
QUALITY MANUAL CONTENT
CONTRACT MANUFACTURING & ANALYSIS
Describe how the company ensures the contract giver or acceptor aware of the duties and responsibilities of each party so as to avoid misunderstanding.

51. QUALITY MANUAL CONTENT
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

52. QUALITY MANUAL CONTENT
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

53. SUMMARY QUALITY MANAGEMENTQA
GMP QC

54. SUMMARY QUALITY DOCUMENTATION
Quality Records
Supporting Documents or Work Instructions
Quality Procedures
Quality Manual

55. SUMMARY GMP Personnel Premise Equipment Sanitation & Hygiene
Production
Quality Control
Documentation
Internal Audit
Storage
Complaints
Product Recall
Contract Manufacturing
& Analysis
RECALL

56. 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

57. RELATED HYPERLINK DOCUMENTS
Trainer manual of Quality Manual
An Example of Quality Manual
An Example of Quality Manual Checking List

58. References ASEAN Guidelines for Cosmetic GMP (2003)
WHO Guide on GMP: Main Principles for Pharmaceutical Products (2005)
PIC/S Guide to GMP for Medicinal Products (2003)
ISO 9000:2000 Standards
Malaysian GMP for Cosmetic, by Ahmad S.H. and Ibrahim M.L. (2004)
Theory and Practice of GMP, by Bennoson M (2002)