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 This module will consist of: Presentation 30 minutes Group discussion minutes Test 40 minutes Exact times will need to be worked out when details of participant numbers and experience are known. The module should be tailored to run between 2 – 3 hours. Module 2 GMP Workshop Kuala Lumpur Nov 2005

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

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

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 Companies can make investments and buy facilities and equipment. However, the greatest resource that a company has is its personnel. But human resources also need a lot of attention. If a company does not have correctly educated, trained and motivated people working in its factory or laboratory, it is necessary to provide training in order to overcome any inherent weaknesses and to build upon existing strengths. Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 The objectives of this training is to provide in-depth understanding to the trainer regarding the requirement of the personnel in the cosmetic manufacturing facilities and to be able to disseminate the information on the organisation structure Module 2 GMP Workshop Kuala Lumpur Nov 2005

SCOPE The module will apply to all personnel in the cosmetic manufacturing facilities, such as : manufacturing quality control warehouse etc. The scope of this module will apply to all personnel in the cosmetic manufacturing facilities: manufacturing, QC, warehouse etc Module 2 GMP Workshop Kuala Lumpur Nov 2005

GENERAL REQUIREMENTS Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 The principle that companies should apply to their people has a number of key features. The personnel is the most important asset of a company, and the easiest to neglect. The establishment and maintenance of a satisfactory system of quality assurance and GMP relies upon people who develop the system, the people who use the system and the people who examine the system to see if it has worked. People are involved, no matter how automated the process or how capital intensive the operation. The behaviour of the people is fundamental to any system of GMP. Personnel policies must reflect this. Sufficient number of staff must be available to carry out the work for which the manufacturer is responsible. These people must have the level of training and experience that will enable them to do their work. The staff must have written job descriptions to ensure that they understand clearly what it is that they have to do, and what they are responsible for. Finally these staff must have a knowledge and understanding of Cosmetic GMP to enable them to carry out their duties in accordance with GMP. Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 Adequate number of qualified people : The key personnel involved in manufacture and quality control must be adequate in number and must have the appropriate qualifications, education, or experience, or combination of these, to carry out tasks the appointed procedures, processes, or equipments effectively. It is most important that the people that are recruited are selected from a group that can meet the requirements. It is not recommended to recruit people to work in manufacturing areas if they are unable to read the instructions for their safety and for product quality. A major and most common problem is that of insufficient people available to do the work. It is of little value having just one person well qualified and experienced, with no backup staff. This can be a very difficult area, and one which is harder for smaller companies than a multinational company or similar. Another issue is the employment of a well qualified, but inexperienced, person to manage, for example, quality. An illustration of this is the recruitment by the owner of a small company of a relative -- niece or nephew for example -- who is newly qualified, but completely inexperienced to run a laboratory or manufacturing area. No extensive job The duties incumbent upon any one individual should not be so extensive that he/she cannot cope, resulting in a risk to quality of the product. Module 2 GMP Workshop Kuala Lumpur Nov 2005

Individual written job description Adequate authority to carry out responsibilities No gaps or unexplained overlaps Organization chart Staff must have a clear job description which tells them and the rest of the company what their role is, what their responsibilities are and what authority they have to carry out their tasks. The company should also have a written organization chart. The combination of organization chart and written job descriptions enables the company to see quickly whether there are any gaps or whether there are any areas of overlap, owing to too many people being involved. The organisation chart should make clear and ensure the independence of QA/QC from production. Personnel involved in QA/QC must have the authority to carry out their responsibilities. This is very easy to say and sometimes not so easy to ensure. Problems can emerge in every size of company, from small private companies to very large multinational enterprises. They arise because of a combination of human interactions, and the pressures placed on people by the business considerations. Managing Director Head of Sales & Marketing Head of Production Head of Quality Control Sales Marketing Processing Packaging IPQC Module 2 GMP Workshop Kuala Lumpur Nov 2005

Prevent unauthorized access to production, storage, quality control Stop personnel who do not work in these areas using them as passageways The company should prevent people who have not been properly trained from entering any production, storage or quality control area without strict supervision. For example: it should not be the case that people from accounts are allowed to walk through the factory to get to the warehouse to pick up or deliver invoices. Access to all other areas of the company should be organized so that no entry to production, storage or laboratory areas is necessary (see Premises). Module 2 GMP Workshop Kuala Lumpur Nov 2005

KEY PERSONNEL Key personnel (normally full time) positions include: Head of Production 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 Description of key personnel : Key people in the organization can be described such as: The heads of production, The head of quality control, The head of sales and marketing The head of distribution Normally they should all be full-time positions. The principle is that there must be independence of quality control from production. The heads of production and quality control should not report to one another (although they may both report to a technical director) but may share certain responsibilities. In large organizations, it may be necessary to delegate some of the functions; however, the responsibility cannot be delegated. Requirement of key personnel : These key personnel must have the education and experience which is appropriate to their positions. As we mentioned earlier, difficulties can arise when family members who are recruited and who are inexperienced. Other key personnel : There are others who play an important role in the operation of the factory, for example, engineers. Engineers are crucial to the maintenance and operation of the facility and equipment, in particular, for the processes of planned preventative maintenance. Module 2 GMP Workshop Kuala Lumpur Nov 2005

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. Key personnel should first of all have the educational background of at least diploma or equivalent in science. This will include a combination of chemistry, biochemistry, chemical engineering, microbiology, pharmaceutical sciences and technology, pharmacology and toxicology, physiology or other related science subjects relevant to the responsibilities to be undertaken. In particular, the GMP text talks about gaining experience not in a haphazard way, but under specific guidance of an expert. This is in order to equip personnel with an ability to take difficult decisions in a professional and scientific way, and to resolve the problems encountered in manufacturing and quality control. It is clear, therefore, that we are talking about professionals who have had a practical as well as an academic training. They should also continue to have training in their area of expertise. There are others who play an important role in the operation of the factory, for example, engineers. Engineers are crucial to the maintenance and operation of the facility and equipment, in particular, for the processes of planned preventative maintenance. Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 The production manager has responsibilities as below: He/she must have in place the systems to ensure that production follows the production instructions that have been prepared for it. He/she must ensure that cosmetic products are produced and stored in accordance with appropriate documentation to meet the required quality standards. He/she is also responsible for the preparation and maintenance of the production instructions and their implementation. This will include not only the production documentation itself, but also all the other procedures and documentation that are essential for the good operation of production. He/she will prepare many of these documents in partnership with quality control and product development staff. The in-process testing requirement must be specified. He/she must ensure that production instructions have been used correctly to record the progress of manufacture. To do this, he/she must evaluate or designate someone to evaluate every batch record in order to satisfy himself/herself that all has gone as it should. He/she will also need to ensure that the documents have been completed correctly. For manufacture to proceed as planned, it is essential that all the plant, facilities and equipment are operating as they should. This means that maintenance must be planned and implemented. This is normally done within a planned preventative maintenance programme. The head of production is responsible for ensuring that all the facilities and equipment under his/her control are properly maintained in accordance with this programme. It is essential to check regularly that the processes will routinely produce a product that meets the registered specifications. The head of production must therefore ensure that all all equipment is calibrated in accordance with the written procedures. We will be talking specifically about weigh scales in this respect when we get to the module on equipment. It is particularly important that the head of production takes responsibility for the conduct of the in-process testing routines agreed with QA/QC. The head of production is responsible for ensuring that the people who carry out all this work are well trained and motivated at the commencement of their work, and that they receive regular refresher training. In some facilities, the head of production may not be responsible for the warehouse. The person who is responsible for the warehouse must store and handle the products in such a way that their quality is unaffected by storage. Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 The responsibilities of a QC manager: He / she should have authority and responsibilities to manage all activities of quality control as follow : The first item on the list is the approval or rejection of all starting and packaging materials and all intermediate, bulk and finished products. This is a critical area and one in which interference can arise particularly when the value of the materials is extremely high, orders have to be met and the owner of the business is directly involved. The QC manager is also responsible for the evaluation of batch records coming from production. This should be done as part of the product release process. The purpose is to be reassured that products have been produced in accordance with the agreed process, and meets specifications. If there have been any deviations from the agreed process, these need to have been authorized by responsible persons. Additional testing may be needed before the product is released for supply. This review process is vital. The QC manager may delegate this review to an authorized person but the responsibility remains his/hers. In some countries this review is done by an authorized person who is, in effect, independent of both production and quality control. The QC manager is responsible for ensuring that all the required testing is completed in accordance with specifications. The QC manager will approve all the instructions that are required for the organisation and implementation of testing. The development of all these instructions, policies and procedures may well be done in co-operation with production and development personnel. The head of QC is responsible for all testing carried out on contract. The head of QC must be assured that the contract accepter: - can conduct the testing to the required standard - has all the necessary personnel - has the necessary equipment to conduct the testing - has a written contract specifying the responsibilities of all parties to the agreement. As with production, the head of QC is responsible for ensuring that all the facilities and equipment under his/her control are properly maintained in accordance with the planned maintenance programme. The head of QC is responsible for the calibration of laboratory equipment to ensure that results achieved by following the processes that can be relied upon. The Head of QC is responsible for ensuring that the people who carry out all this work are well trained and motivated at the commencement of their work and that they receive regular training and retraining. The quality control function has other duties as well, such as : Manage internal quality audit Manage customer complaint Manage product recalled Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 Clear written job descriptions must be available for these positions, showing where the shared responsibilities are. Several share responsibilities can be described as follow : It is sensible that all procedures and documents used in manufacturing are approved by both the production and quality control departments. It is most important that an effective system of change control is implemented. It is essential that as SOPs are changed, all those who use them are given the latest version. Monitoring of the manufacturing environment is a task to be shared between QA/QC and production. These departments should conduct the monitoring and testing as appropriate, with the results made available to all who need to know. Both production and quality control have a role to play in the development and maintenance of an appropriate factory sanitation and hygiene management system. Both have a major contribution in the the calibration of equipment. A comprehensive training programme is required for personnel. The production and quality control department have a role to play in the development of the training programme. The heads of these departments, therefore, have a shared responsibility for the implementation of that programme. Approval of all suppliers and contract manufacturers is also an area of shared responsibility, with each contributing his/her own particular expertise Responsibility for the designation and monitoring of storage conditions is also shared. Since both have responsibility for the generation of records relevant to batches, then the arrangements for the storage of those records may be a shared responsibility. Alternatively a separate department may be available that manages all aspects of documentation and batch records. Monitoring of compliance with GMP is also a shared responsibility. This has to be correct because the achievement of GMP is everyone's responsibility. Module 2 GMP Workshop Kuala Lumpur Nov 2005

CLEAR RESPONSIBILITY Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 Nov 2005

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 Each company should establish a written training programme. New employees understand what is expected of them and the risks to patients and consumers if the products they make do not conform to requirements. This initial training must be given to all employees who have a direct impact on product quality All areas of GMP relevant to the individual must be covered. . The training programme may consist of at least two parts. The first will be a general programme that all employees should receive which explains GMP and the importance of GMP to the company. The second programme, explaining the specific issues about the individual’s department. The continuous training programme with good documentation: There should be a written re-training programme for all employees to ensure that their skills are continually brought up to date and that they are introduced to changes in practice as these develop. As employees go through their training, records should be kept of the training received and performance against tests. People have to realise that good performance is required otherwise retraining will be required. Training records must be kept to ensure that as employees move around the company, they are not required to carry out work for which they have not been trained. Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 Training for staff who working in the special areas: People who work in special areas should receive additional training in the special nature of their area of work. Those people who work with hazardous materials should receive specific instruction in the special nature and hazards associated with this activity. During training, every encouragement should be given to employees to discuss fully all aspects of quality and GMP with their trainers and among themselves. Staff should be encouraged to contribute to increased quality and GMP. Practical effectiveness should be periodically assessed eg. Assessment tests, Number of rejects/ product complaint/ return products Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 Access for visitor : Visitor or untrained personnel should be treated as a potential risk to the product and, therefore, steps should be taken to ensure that they cannot cause any hazard to product quality. It is necessary to give visitors a full briefing and to provide them with full protective clothing and give them strict instructions about where they may stand. For visitors there can be no exceptions to the rule of the wearing of appropriate clothing to protect the product. Limited access for visitor(s) Every visitor should be accompanied by internal responsible personnel Problem may arise when the owner of the company have business visitors, because sometime owners may feel that if the company is theirs, they may do what they want, when they want. Somehow they have to understand that their investment is at risk if they do not behave as necessary. Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 Healthy condition : There should be pre-employment and periodic medical checks Steps should be taken to see that no person with a disease in a communicable form, or with open lesions on the exposed surface of the body, is engaged in the manufacture cosmetic products Personnel hygiene : Personnel should wear clean protective garment. Garments should be of such material and weave that they are comfortable to wear and contamination can be minimised Personnel working in areas designated as “clean” (such as production room for cosmetic products which used around the eyes) should change into clean over garments before moving into “culturing” areas, and the over garments must be removed on exit from the relevant area. Movement of staff from culturing areas to clean/aseptic areas should be avoided. Eating, drinking, smoking, and chewing are not allowed in production and laboratory area Personnel should be required to report infections and skin lesions, and a defined procedure followed when they are reported. Supervisory staff should look for the signs and symptoms of these conditions Personnel should be instructed and encouraged to report to their supervisors any signs or symptoms of infectious disease which they may have acquired or to report any condition (e.g. diarrhoea, coughs, colds, infected skin or hair, wounds) which may cause the shedding of abnormal numbers of types of contaminants. The nature of the action to be taken regarding utilisation of such persons for biological work should be decided by a designated competent person Module 2 GMP Workshop Kuala Lumpur Nov 2005

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 Nov 2005

RELATED HYPERLINK DOCUMENTS
Trainer manual of personnel module ASEAN GMP Personnel Hygiene Module 2 GMP Workshop Kuala Lumpur Nov 2005

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

THANK YOU for your attention Subsidiaries of multinational companies may claim that company procedures or standards take precedence over local legislation. If this is claimed, it will be most unusual since all multinationals require local companies to conform first to local legislation. It will be worth exploring with the company what benefits are obtained by not conforming to local legislation. Large organizations often move people around through promotion, training, recruitment or relocation. In so doing they can lose sight of the requirements of GMP. Managers can be promoted into positions for which they are not qualified or experienced. Companies may not keep adequate training records even though people are apparently undergoing training. As with small companies, large companies may have personnel policies that penalize people. The problem is that if people are not going to be paid when sick or injured, they may work on under circumstances that create a risk to the product. What happens when they have an open wound, for example? Module 2 GMP Workshop Kuala Lumpur Nov 2005

ASEAN GMP TRAINING MODULE PERSONNEL

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