Quality Systems Approach

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 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

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

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. STATEMENT OF RIGHTS & RESPONSIBILITIES 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.

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. 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. 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. 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. 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.

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. 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 Management Quality Assurance G.M.P. QUALITY RELATIONSHIP 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. Quality Manual Quality Procedures Supporting Documents or Work Instructions Quality Records 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

27. QSP #02 QUALITY STANDARD PROCEDURE 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 27

28. Quality Manual Quality Procedures Supporting Documents or Work Instructions Quality Records 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.

29. Quality Manual Quality Procedures Supporting Documents or Work Instructions Quality Records QUALITY PROCEDURES The tactical document that outlines the activities or operations of the organization in implementing the stated quality policies. The Quality Proceduresshould 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.

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

31. Quality Manual Quality Procedures Supporting Documents or Work Instructions Quality Records 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

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

33. QUALITY MANUAL DESCRIPTION (1) • This Quality Manual should state thecompany’scommitmenttoqualityand 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 clearlydefined and documented quality policy statement thatstates the company’s commitment to produce safe and quality products and itsresponsibility to its customers. • The company’s seniormanagement shall demonstrate commitment to theimplementation of the Company Quality Policy bysigning off the policy. • All supervisory staff andkey personnel shall understand and implement thepolicy. • The quality policy shall be communicated to all staff of thecompany 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 torelevant staff. • The company’s management shallregularly review its quality system toensure 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 123456 • 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. 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. 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