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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?
Prepared byHui Foong Mei – Singapore
Vongsavanh Insixiengmay – Laos PDRDavong Oumavong – Laos PDR
Approved byASEAN Cosmetic GMP Team
Endorsed byASEAN Cosmetic Committee
ASEAN GMP TRAINING MODULE
QUALITY MANAGEMENT SYSTEM
CONTENT OF PRESENTATION
1. Basic Principles of Quality Managementa. Basic Principles of Quality Assuranceb. Basic Requirements of Quality Assurancec. Basic Principles of GMPd. Basic Requirements of GMPe. Basic Principles of Quality Controlf. Basic Requirements of Quality Control
2. Basic Principle of Quality Documentation
3. Establishment of Quality Manual
To understand key concepts of quality management, quality assurance, GMP and quality control.
To understand level of quality documentation.
To understand specific requirements on quality manual.
To develop quality manual based on GMP requirements
OBJECTIVES
BASIC PRINCIPLE OF
QUALITY MANAGEMENT
Manufacturer should ensure the cosmetic products comply with the requirements of ASEAN Cosmetic Directives (ACD).
They should also comply with any other applicable regulations pertaining to your specific country.
The attainment of this quality objective should be led by the senior management and requires the participation and commitment by staff, by the company’s suppliers and distributors.
BASIC PRINCIPLE OF
QUALITY MANAGEMENT (1)
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
BASIC PRINCIPLE OFQUALITY MANAGEMENT (2)
QA covers all matters which individually or collectively influence the quality of a product.
It refers to a sum total of activities organized with an aim to ensure the products are of the required quality.
QA incorporates GMP and other factors that fall outside the scope of the GMP Guide.
BASIC PRINCIPLE OFQUALITY 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.
BASIC REQUIREMENTS OFQUALITY ASSURANCE (1)
STATEMENTOF
RIGHTS&
RESPONSIBILITIES
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.
BASIC REQUIREMENTS OFQUALITY ASSURANCE (2)
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.
BASIC PRINCIPLES OFGOOD 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
BASIC PRINCIPLES OFGOOD 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
BASIC PRINCIPLES OFGOOD MANUFACURING PRACTICES (3)
QC is part of GMP.
QC is concerned with sampling, specification and testing.
Manufacturer should have a QC department.
QC should be headed by an appropriately qualified and experienced person.
QC should be independent from production and other departments.
Ensure that the necessary and relevant tests are actually carried out.
Ensure that no materials or products will be released for sale or supply, until their quality have been evaluated and judged to be satisfactory.
BASIC PRINCIPLES OFQUALITY CONTROL (1)
Items concerned : Starting materials Packaging materials Bulk products Intermediate and finished products Environmental conditions
SCOPE OF QC
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.
BASIC REQUIREMENTS OFQUALITY CONTROL (1)
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
BASIC REQUIREMENTS OFQUALITY CONTROL (2)
Establish QC procedures Manage reference standards Ensure correct labeling Stability testing (if applicable) Complaint investigation Environmental monitoring
OTHER DUTIES OF QC
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
QUALITY CONTROL ASSESSMENT OF
MANUFACTURING ACTIVITY
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
QUALITY CONTROL ACTIVITIES
Quality Management
Quality Assurance
G.M.P.
Quality Control
QUALITY RELATIONSHIP
BASIC PRINCIPLE OFDOCUMENTATION
To establish, monitor, and record “quality” for all aspects of the
production, quality control and quality assurance.
A reliable evidence for GMP compliance.
OBJECTIVE OF DOCUMENTATION
Clearly written documentation prevents errors
It provides assurance that quality related activities are carried out exactly the way they have been planned and approved
Employees know what to do
Responsibilities and authorities are identified
Forms the basis for improvement
PURPOSE OF DOCUMENTATION
Documentation is the key to operating a cosmetic company in compliance with GMP requirements.
All the elements, requirements and provisions adopted by cosmetic company for its quality system should be documented in a systematic, orderly and understandable manner in the form of policies and procedures.
Documents should be developed, prepared, approved, reviewed and distributed in a controlled manner.
It should be written in detail and in simple language that can be understood by the user.
QUALITY SYSTEM DOCUMENTATION
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
Quality Records
Supporting Documents or Work
Instructions
Quality Procedures
Quality Manual
TIERS OF DOCUMENTATION (1)
27
WORKINSTRUCTIONS
WI #03
WORKINSTRUCTIONS
WI #02
WORKINSTRUCTIONS
WI #01 WORKPROTOCOLS
WP #03
PWORKPROTOCOLS
WP #02
WORKPROTOCOLS
WP #01 STANDARDTEST/
SPECIFICATION
STD #03
STANDARDTEST/
SPECIFICATION
STD #02
STANDARDTESTS /
SPECIFICATION
STD #01 CODE ETIK / WORKPOLICY
CE #03
CODE ETIK / WORKPOLICY
CE #02
CODE ETHIC / WORK POLICY
CE #01
QUALITYMANUAL
QM
LABELIDENTITAS
IL #03
LABELIDENTITAS
IL #02
IDENTITYLABELS
IL #01
QUALITYSTANDARD PROCEDURE
QSP #03
QUALITYSTANDARDPROCEDURE
QSP #02
QUALITYSTANDARD PROCEDURE
QSP #01
TIERS OF DOCUMENTATION (2)
Quality Records
Supporting Documents or Work
Instructions
Quality Procedures
Quality Manual
The strategic document that outlines the organization’s system of providing quality assurance to achieve customer satisfaction.
The Quality Manual could be in one document supported by several tiers of document, each becoming progressively more detailed.
The Quality Manual should define the policy of the company, the organisational structure, functions, responsibilities, procedures, instructions, processes and resources for implementing the quality management.
QUALITY MANUAL
Quality Records
Supporting Documents or Work
Instructions
Quality Procedure
s
Quality Manual
The tactical document that outlines the activities or operations of the organization in implementing the
stated quality policies.
The Quality Procedures should ensure that if necessary, samples 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 PROCEDURES
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
The operational document containing instructions specifying how the activities are performed or products are accepted.
WORK INSTRUCTION
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 storageQuality Records
Supporting Documents or Work
Instructions
Quality Procedures
Quality Manual
Quality Records refer to results as well as charts and data pertaining to activities performed such inspection, testing, survey, audit, review, etc. They should be maintained as important evidence
to demonstrate :
QUALITY RECORD
Quality Records
Supporting Documents or Work Instructions
Quality Procedures
Quality Manual
Main Points for Consideration
ESTABLISHMENT OF QUALITY MANUAL
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.
QUALITY MANUAL DESCRIPTION (1)
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.
QUALITY MANUAL DESCRIPTION (2)
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.
QUALITY MANUAL DESCRIPTION (3)
Quality manual can be prepared according to ISO prescribed format if it does incorporate the GMP principles or it should contain the following features :
Title and Scope – which company sites and operations are covered?Example:• This manual describes the quality arrangements for
manufacturing process starting from receiving of starting materials to delivery of finished products which are manufactured at :
1 Sembawang AvenueSingapore 123456
• This manual describes the policies and summaries of the quality management system established.
PREPARATION OF A QUALITY MANUAL
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
Change in company’s name18 June 2000QM – GMP / 002
Change of job description of QC i/c (Para 1.5)
1 March 1999QM – GMP / 001
Reasons for RevisionDate of RevisionRef. No.
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
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.
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?
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
PREPARATION OF A QUALITY MANUAL
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
QUALITY MANUAL CONTENT
PREMISES
Describe the requirements of the design, installation and maintenance of the equipment and its support system such as ventilation system.
QUALITY MANUAL CONTENT
EQUIPMENT
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
QUALITY MANUAL CONTENT
SANITATION & HYGIENE
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
QUALITY MANUAL CONTENT
PRODUCTION
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
QUALITY MANUAL CONTENT
QUALITY CONTROL
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
QUALITY MANUAL CONTENT
DOCUMENTATION
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
QUALITY MANUAL CONTENT
INTERNAL AUDIT
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)
QUALITY MANUAL CONTENT
STORAGE
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
QUALITY MANUAL CONTENT
PRODUCT COMPLAINT
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
QUALITY MANUAL CONTENT
PRODUCT RECALL
SUMMARY QUALITY MANAGEMENT
QA
GMP
QC
Quality Records
Supporting Documents or Work Instructions
Quality Procedures
Quality Manual
SUMMARY QUALITY DOCUMENTATION
SUMMARY GMP
Personnel
Premise
Equipment
Sanitation & Hygiene
Production
Quality ControlDocumentation
Internal Audit
Storage
Complaints
Product Recall
Contract Manufacturin
g& Analysis
RECALL
• Title & Version Number• Table of Content• Introduction of the Company• Quality Policy Statement• Scope• Organisation Structure/ Responsibilities of key personnel• Abbreviation of terms• Management Representative• Revision History• Quality and Management Objectives & Policies• Reference of procedure list• Controlled document• Document Approval Information • Circulation List
SUMMARY QUALITY MANUAL
RELATED HYPERLINK DOCUMENTS
Trainer manual of Quality Manual An Example of Quality Manual An Example of Quality Manual Checking
List
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)
