Project co-financed by European Union Project co- financed by Asean ASEAN GMP TRAINING MODULE PERSONNEL Prepared by Rosni Jair - Brunei Darussalam Approved by ASEAN GMP Team Endorsed by ASEAN Cosmetic Committee European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 1
Project co-financed by European Union CONTENT OF PRESENTATION n n n n n European Committee for Standardization Implementing Agency Project co- financed by Asean Objectives Scope Principle General Key personnel Training Personal hygiene Related hyperlink documents References Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 2
Project co-financed by European Union Project co- financed by Asean INTRODUCTION European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 3
Project co-financed by European Union INTRODUCTION Project co- financed by Asean 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 European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 4
Project co-financed by European Union OBJECTIVE Project co- financed by Asean • 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 European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 5
Project co-financed by European Union SCOPE Project co- financed by Asean The module will apply to all personnel in the cosmetic manufacturing facilities, such as : • manufacturing • quality control • warehouse etc. European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 6
Project co-financed by European Union Project co- financed by Asean GENERAL REQUIREMENTS European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 7
Project co-financed by European Union PRINCIPLE Project co- financed by Asean • 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 European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 8
Project co-financed by European Union GENERAL REQUIREMENT (1) Project co- financed by Asean • 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 European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 9
Project co-financed by European Union GENERAL REQUIREMENT (2) Project co- financed by Asean • Individual written job description • Adequate authority to carry out responsibilities • No gaps or unexplained overlaps • Organization chart Managing Director Head of Sales & Marketing Sales European Committee for Standardization Implementing Agency Marketing Head of Production Processing Packaging Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 Head of Quality Control IPQC 10
Project co-financed by European Union GENERAL REQUIREMENT (3) Project co- financed by Asean • Prevent unauthorized access to production, storage, quality control • Stop personnel who do not work in these areas using them as passageways European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 11
Project co-financed by European Union KEY PERSONNEL Project co- financed by Asean • Key personnel (normally full time) positions include: ü Head of Production ü Head of Quality Control • Heads of Production and Quality Control should be independent of each other • For a large organisation – may be necessary to delegate some of the functions; however, the responsibility cannot be delegated European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 12
Project co-financed by European Union KEY PERSONNEL QUALIFICATION Project co- financed by Asean F Key personnel should be appropriately qualified and/or possess adequate practical experience F Examples of desirable qualifications include: Ø chemistry, biochemistry, chemical engineering, microbiology, pharmaceutical sciences and technology, pharmacology and toxicology, physiology; or Ø other related science or GMP-related subjects relevant to the responsibilities to be undertaken F Practical experience. Ø under professional guidance Ø able to take difficult decisions in a professional and scientific way, Ø resolve the problems encountered in manufacturing and QC. European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 13
Project co-financed by European Union HEAD OF PRODUCTION Project co- financed by Asean He / she should have authority and responsibilities to manage production of cosmetic products, which cover : Ø Product production and storage according to appropriate documentation Ø Approval and implementation of production instructions, inprocess QC and ensure strict implementation Ø Evaluate production records; signed by designated person before passing to QC Ø Maintenance of production department, premises and equipment Ø Calibration performed, recorded and reports made available Ø Training of production personnel; initial and continuing European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 14
Project co-financed by European Union HEAD OF QUALITY CONTROL Project co- financed by Asean • 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 European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 15
Project co-financed by European Union SHARED RESPONSIBILITIES Project co- financed by Asean 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 European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 16
Project co-financed by European Union CLEAR RESPONSIBILITY European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 Project co- financed by Asean 17
Project co-financed by European Union JOB DESCRIPTION EXAMPLE Project co- financed by Asean 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. European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 18
Project co-financed by European Union PERSONNEL TRAINING (1) Project co- financed by Asean l Training, in accordance with a written programme for Ø all personnel whose duties take them into production; or Ø into control laboratories; and Ø for others whose activities could affect the quality of the product l On induction and continuing Ø on theory and practice of GMP; Ø approved by either the head of Production or QC as appropriate Ø training records should be kept Ø training before undertaking any new task European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 19
Project co-financed by European Union PERSONNEL TRAINING (2) Project co- financed by Asean Staff in special areas, e. g. Ø working with hazardous materials should be given specific training l The concept of QA and its understanding and implementation should be fully discussed during training l Practical effectiveness should be periodically assessed e. g. assessment tests, number of rejects, product complaint, return products l European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 20
Project co-financed by European Union Project co- financed by Asean VISITOR OR UNTRAINED PERSONNEL l Must be given information in advance, particularly about personal hygiene; and protective clothing requirements l Must be accompanied and closely supervised at all times European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 21
Project co-financed by European Union PERSONNEL HYGIENE (1) l All personnel must undergo health examination l Project co- financed by Asean Trained in the practice of personnel hygiene Illness or open lesions – not allowed Report to supervisors any conditions adversely affect the product quality l l European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 22
Project co-financed by European Union PERSONNEL HYGIENE (2) Project co- financed by Asean l Avoid direct contact of operator’s hands and products including starting/ packaging materials l Wear clean body covering l Smoking, eating, drinking, chewing and keeping materials not related to production not permitted l Use of protective clothing in production areas European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 23
Project co-financed by European Union Project co- financed by Asean RELATED HYPERLINK DOCUMENTS & Trainer manual of personnel module & ASEAN GMP Personnel Hygiene European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 24
Project co-financed by European Union REFERENCES Project co- financed by Asean 1. ASEAN Guidelines for Cosmetic GMP (2003) 2. WHO - EDM, Basic Principle of GMP: Personnel (2004) European Committee for Standardization Implementing Agency Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 25
Project co-financed by European Union European Committee for Standardization Implementing Agency Project co- financed by Asean Module 2 GMP Workshop Kuala Lumpur 14 -16 Nov 2005 26
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