Module 1

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ASEAN GMP TRAINING MODULEQUALITY 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

• 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

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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 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
  companys suppliers and distributors.

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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

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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.

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BASIC REQUIREMENTS OF 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.
• 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.

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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.

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BASIC PRINCIPLES OF 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 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 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 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 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 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 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
• 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

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QUALITY RELATIONSHIP
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)

• 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

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 STANDARD PROCEDURE
QSP 01
QUALITY STANDARD PROCEDURE
WI 03
WP 03
STD 03
CE 03
IL 03
STANDARD TEST/ SPECIFICATION
IL 02
WI 02
WP 02
STD 02
CE 02
LABEL IDENTITAS
WI 01
WP 01
STD 01
CE 01
IL 01
WORK INSTRUCTIONS
WORK PROTOCOLS
STANDARD TEST/ SPECIFICATION
CODE ETIK / WORK POLICY
LABEL IDENTITAS
WORK INSTRUCTIONS
PWORK PROTOCOLS
CODE ETIK / WORK POLICY
STANDARD TESTS / SPECIFICATION
IDENTITY LABELS
WORK INSTRUCTIONS
WORK PROTOCOLS
CODE ETHIC / WORK POLICY
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QUALITY MANUAL
The strategic document that outlines the
organizations 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 structure, functions,
responsibilities, procedures, instructions,
processes and resources for implementing 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 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
organizations 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 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.
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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 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

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ESTABLISHMENT OF QUALITY MANUAL
Main Points for Consideration
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QUALITY MANUAL DESCRIPTION (1)

• This Quality Manual should state the companys
  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 companys commitment to produce
  safe and quality products and its responsibility
  to its customers.
• The companys 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 continuing suitability.

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

Reasons for Revision
Date of Revision
Ref. No.
Change of job description of QC i/c (Para 1.5)
1 March 1999
QM GMP / 001
Change in companys name
18 June 2000
QM GMP / 002
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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
• Personnel 8. Internal Audit
• Premises 9. Storage
• Equipment 10. Contract Manufacturing
• Sanitation Hygiene Analysis
• Production 11. Product Complaint
• Quality Control 12. 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.

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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 companys policies on
• Criteria of staff involved in the manufacturing
  activities
• Assuring staffs competency in their work
• Assuring staffs understanding of procedures,
  work instruction, GMP principles , etc
• Assuring that there is no ambiguity of staffs
  roles and responsibilities
• Staff resources allocation
• Authority of QC and Production

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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

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QUALITY MANUAL CONTENT 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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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

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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

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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

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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

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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

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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)

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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.

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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

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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

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SUMMARY QUALITY MANAGEMENT
QC
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SUMMARY QUALITY DOCUMENTATION
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SUMMARY GMP
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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

 
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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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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 90002000 Standards
• Malaysian GMP for Cosmetic, by Ahmad S.H. and
  Ibrahim M.L. (2004)
• Theory and Practice of GMP, by Bennoson M (2002)

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Thank you for Your Kind Attention