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ASEAN GMP TRAINING MODULE PERSONNEL

ASEAN GMP TRAINING MODULE PERSONNEL. Prepared by Rosni Jair - Brunei Darussalam Approved by ASEAN GMP Team Endorsed by ASEAN Cosmetic Committee. CONTENT OF PRESENTATION. Objectives Scope Principle General Key p ersonnel Training Personal h ygiene Related hyperlink documents

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ASEAN GMP TRAINING MODULE PERSONNEL

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  1. ASEAN GMP TRAINING MODULEPERSONNEL • Prepared by • Rosni Jair - Brunei Darussalam • Approved by • ASEAN GMP Team • Endorsed by • ASEAN Cosmetic Committee Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  2. CONTENT OF PRESENTATION • Objectives • Scope • Principle • General • Key personnel • Training • Personal hygiene • Related hyperlink documents • References Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  3. INTRODUCTION Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  4. INTRODUCTION • Companies can make investments and buy facilities and equipment. However, the greatest resource that a company has is its personnel. • Cosmetic company should ensure that there are sufficient qualified key personnel and staffs who are adequately trained in the principles and application of GMP to ensure: • protection of the health of all personnel; • protection of the product from contamination; and • protection of product quality Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  5. OBJECTIVE • To provide in-depth understanding regarding general requirement of the personnel in the cosmetic manufacturing facilities • To be able to disseminate the information on the organisation structure Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  6. SCOPE The module will apply to all personnel inthe cosmetic manufacturing facilities, such as : • manufacturing • quality control • warehouse etc. Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  7. GENERAL REQUIREMENTS Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  8. PRINCIPLE • Establishment and maintenance of satisfactory system of QA and manufacturing of cosmetic products relies on people. • Sufficient qualified personnel to carry out tasks • Individual responsibilities must be clearly understood by individuals concerned • All personnel should be aware of the principles of cosmetic GMP that affect them and continuing training including hygiene instructions, relevant to their needs Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  9. GENERAL REQUIREMENT (1) • Adequate number of qualified people with practical experience versus procedures, processes, equipments • An individual’s responsibilities should not be so extensive as to present a risk to quality Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  10. Sales Marketing Processing Packaging GENERAL REQUIREMENT (2) • Individual written job description • Adequate authority to carry out responsibilities • No gaps or unexplained overlaps • Organization chart Managing Director Head of Sales & Marketing Head of Production Head of Quality Control IPQC Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  11. GENERAL REQUIREMENT (3) • Prevent unauthorized access to production, storage, quality control • Stop personnel who do not work in these areas using them as passageways Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  12. KEY PERSONNEL • Key personnel (normally full time) positionsinclude: • Head of Production • Head of Quality Control • Heads of Production and Quality Control should be independent of each other • For a largeorganisation – may be necessary to delegate some of the functions; however, the responsibility cannot be delegated Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  13. KEY PERSONNEL QUALIFICATION • Key personnel should be appropriately qualified and/or possess adequate practical experience • Examples of desirable qualifications include: • chemistry, biochemistry, chemical engineering, microbiology, pharmaceutical sciences and technology, pharmacology and toxicology, physiology; or • other related science or GMP-related subjects relevant to the responsibilities to be undertaken • Practical experience. • under professional guidance • able to take difficult decisions in a professional and scientific way, • resolve the problems encountered in manufacturing and QC. Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  14. HEAD OF PRODUCTION He / she should have authority and responsibilities to manage production of cosmetic products, which cover : • Product production and storage according to appropriate documentation • Approval and implementation of production instructions, in-process QC and ensure strict implementation • Evaluate production records; signed by designated person before passing to QC • Maintenance of production department, premises and equipment • Calibration performed, recorded and reports made available • Training of production personnel; initial and continuing Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  15. HEAD OF QUALITY CONTROL • Approval or rejection of materials, packing materials, intermediates, bulk and finished products • Evaluation of batch records • Carrying out of necessary testing • Approval of quality control procedures such as sampling instructions, specifications, test methods, and other QC procedures • Approval and monitoring of all contract analysis • Maintenance of quality laboratory, including equipments and laboratory apparatus • Calibration of control equipments • Initial and continuous training of QC personnel Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  16. SHARED RESPONSIBILITIES Heads of Production and Quality Control may share some responsibilities, such as: • authorization of written procedures (SOPs) and other documents, including amendments • environmental monitoring and control, and plant hygiene • calibration • training, including application and principles of QA • approval and monitoring suppliers • designation and monitoring of storage conditions • retention of records • monitoring compliance with GMP • inspection, investigation, and taking of samples to monitor factors which may affect quality • corrective and preventive actions Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  17. CLEAR RESPONSIBILITY Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  18. JOB DESCRIPTION EXAMPLE • Plant Manager • To ensure that adequate resources are being effectively distributed in each single operation. • Supervise and provide technical supports to quality control, production and administration functions. • Responsible to review and approve all production and process related documents and SOPs. • Ultimate responsible of the quality system of the plant. • To ensure that good manufacturing and safety practices are being exercised and implemented in the plant. • Responsible to maintain all staff qualification records and identify the training needs for key personnel. • Responsible to review the quality system at defined intervals sufficient to ensure its continuing suitability and effectiveness. • Prompt the QC functions, for initiating any investigation and measures. Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  19. PERSONNEL TRAINING (1) • Training, in accordance with a written programme for • all personnel whose duties take them into production; or • into control laboratories; and • for others whose activities could affect the quality of the product • On induction and continuing • on theory and practice of GMP; • approved by either the head of Production or QC as appropriate • training records should be kept • training before undertaking any new task Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  20. PERSONNEL TRAINING (2) • Staff in special areas, e.g. • working with hazardous materials should be given specific training • The concept of QA and its understanding and implementation should be fully discussed during training • Practical effectiveness should be periodically assessed e.g. assessment tests, number of rejects, product complaint, return products Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  21. VISITOR OR UNTRAINED PERSONNEL • Must be given information in advance, particularly about • personal hygiene; and • protective clothing requirements • Must be accompanied and closely supervised at all times Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  22. PERSONNEL HYGIENE (1) • All personnel must undergo health examination • Trained in the practice of personnel hygiene • Illness or open lesions – not allowed • Report to supervisors any conditions adversely affect the product quality Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  23. PERSONNEL HYGIENE (2) • Avoid direct contact of operator’s hands and products including starting/ packaging materials • Wear clean body covering • Smoking, eating, drinking, chewing and keeping materials not related to production not permitted • Use of protective clothing in production areas Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  24. RELATED HYPERLINK DOCUMENTS • Trainer manual of personnel module • ASEAN GMP Personnel Hygiene Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  25. REFERENCES • ASEAN Guidelines for Cosmetic GMP (2003) • WHO - EDM, Basic Principle of GMP: Personnel (2004) Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

  26. THANK YOU for your attention Module 2 GMP Workshop Kuala Lumpur 14-16 Nov 2005

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