ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM

1. 1 Module 1 GMP Workshop Kuala Lumpur 14-16 November 2005 ASEAN GMP TRAINING MODULEQUALITY MANAGEMENT SYSTEM Complaint handling is defined in the ASEAN Cosmetic GMP. One necessary but not always pleasant aspect of quality management is dealing with complaints. Complaint handling is defined in the ASEAN Cosmetic GMP. One necessary but not always pleasant aspect of quality management is dealing with complaints.

2. Module 1 GMP Workshop Kuala Lumpur 14-16 November 2 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 ReferencesContent 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

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5. Module 1 GMP Workshop Kuala Lumpur 14-16 November 5 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.

6. Module 1 GMP Workshop Kuala Lumpur 14-16 November 6 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

7. Module 1 GMP Workshop Kuala Lumpur 14-16 November 7 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.

8. Module 1 GMP Workshop Kuala Lumpur 14-16 November 8 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.

9. Module 1 GMP Workshop Kuala Lumpur 14-16 November 9 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.

10. Module 1 GMP Workshop Kuala Lumpur 14-16 November 10 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.

11. Module 1 GMP Workshop Kuala Lumpur 14-16 November 11 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

12. Module 1 GMP Workshop Kuala Lumpur 14-16 November 12 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

13. Module 1 GMP Workshop Kuala Lumpur 14-16 November 13 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.

14. Module 1 GMP Workshop Kuala Lumpur 14-16 November 14 Items concerned : Starting materials Packaging materials Bulk products Intermediate and finished products Environmental conditions

15. Module 1 GMP Workshop Kuala Lumpur 14-16 November 15 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.

16. Module 1 GMP Workshop Kuala Lumpur 14-16 November 16 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

17. Module 1 GMP Workshop Kuala Lumpur 14-16 November 17 Establish QC procedures Manage reference standards Ensure correct labeling Stability testing (if applicable) Complaint investigation Environmental monitoring

18. Module 1 GMP Workshop Kuala Lumpur 14-16 November 18 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

19. Module 1 GMP Workshop Kuala Lumpur 14-16 November 19 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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32. Module 1 GMP Workshop Kuala Lumpur 14-16 November 32 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.



35. Module 1 GMP Workshop Kuala Lumpur 14-16 November 35 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.

36. Module 1 GMP Workshop Kuala Lumpur 14-16 November 36 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

37. Module 1 GMP Workshop Kuala Lumpur 14-16 November 37 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

38. Module 1 GMP Workshop Kuala Lumpur 14-16 November 38 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.

39. Module 1 GMP Workshop Kuala Lumpur 14-16 November 39 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?

40. Module 1 GMP Workshop Kuala Lumpur 14-16 November 40 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

41. Module 1 GMP Workshop Kuala Lumpur 14-16 November 41 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

42. Module 1 GMP Workshop Kuala Lumpur 14-16 November 42 Describe the requirements of the design, installation and maintenance of the equipment and its support system such as ventilation system.


44. Module 1 GMP Workshop Kuala Lumpur 14-16 November 44 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

45. Module 1 GMP Workshop Kuala Lumpur 14-16 November 45 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

46. Module 1 GMP Workshop Kuala Lumpur 14-16 November 46 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

47. Module 1 GMP Workshop Kuala Lumpur 14-16 November 47 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

48. Module 1 GMP Workshop Kuala Lumpur 14-16 November 48 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)

49. Module 1 GMP Workshop Kuala Lumpur 14-16 November 49 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. Module 1 GMP Workshop Kuala Lumpur 14-16 November 51 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








ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM

ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM

Presentation Transcript

ASEAN GMP TRAINING MODULE PRODUCT RECALL

ASEAN GMP TRAINING MODULE PRODUCT COMPLAINT

SUPPLEMENTARY ASEAN GMP TRAINING MODULE PEST CONTROL

ASEAN GMP TRAINING MODULE DOCUMENTATION

ASEAN GMP SUPLEMENTARY TRAINING MODULE CONTAMINATION & GOOD HOUSEKEEPING

Quality Management System

Food Safety Quality Management System Training Guide SQF Code Module 11

Quality Management System

ASEAN GMP TRAINING MODULE QUALITY CONTROL

ASEAN GMP TRAINING MODULE STORAGE

ASEAN GMP TRAINING MODULE PRODUCTION

ASEAN GMP TRAINING MODULE PRODUCT COMPLAINT

ASEAN GMP TRAINING MODULE SANITATION & HYGIENE

ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM

SUPPLEMENTARY ASEAN GMP TRAINING MODULE EQUIPMENT SANITATION

Quality Management System

ASEAN GMP TRAINING MODULE SANITATION & HYGIENE

ASEAN GMP TRAINING MODULE QUALITY CONTROL

ASEAN GMP TRAINING MODULE PRODUCT COMPLAINT

ASEAN GMP TRAINING MODULE PERSONNEL

ASEAN GMP TRAINING MODULE QUALITY MANAGEMENT SYSTEM