|WHO Basic Training Modules on Good Manufacturing Practices (GMP)|
Basic Principles of GMP: Module 1
GMP Inspection Process: Module 2
These notes complement the WHO training programmes Basic Principles of GMP, GMP Inspection Process and four advanced modules (supplementary training modules). They should be used to assist in the preparation and delivery of courses using some or all of the modules from the two programmes.
The training programmes have been prepared to allow the courses to be given without further development of course material. However, it is essential that the trainer has sufficient first-hand experience of the pharmaceutical manufacturing to be able to provide examples and case studies, both during the presentations and in the group sessions. It is also important that local issues are considered throughout the course.
The basis of all materials is the relevant WHO Technical Reports. A full list of these reports is given at the end of these notes. In order to explain the texts, different words have been used in the training modules to illustrate each of the key issues.
Each module is based on approximately quarter day units of 2 hours each (see above regarding timings of modules). Depending on the subject, there will be 1, 2, 3, or 4 units to a module. Each unit is made up of a 30-60 minute presentation, a group session lasting 30-60 minutes, a plenary feedback session of approximately 30 minutes, depending on the number of groups. Group sessions rely on brainstorming. The trainer should be prepared to explain the technique. The modules also have a short test to assess understanding by the trainees.
The course material is divided into two parts - the trainerís binder and the traineesí binder.
The trainerís binder consists of the following items:
The objectives of the module are covered by the second transparency in each case.
The speakerís notes are not intended to be read aloud as a lecture. Rather they are provided as resource material or as memory joggers as it is expected that the trainer should have a good understanding of the GMP issues already.
The worksheets consist of the group questions. Discussion points are given at the end of the speakersí notes. The trainer and his/her team should move between the groups and facilitate the discussion by raising the points if they have not already been covered by the group themselves. Since the trainers are likely to vary between experienced inspectors and new recruits with no industry experience, the questions are varied accordingly. Trainers should also think about cultural implications.
The test papers take the form of multiple choice questions that can be marked by the trainer in a short period of time and can be used to identify areas that require further explanation and discussion. For good learning, it is important to review the questions and answers with all participants.
The training course should not stand in isolation, but should be seen as part of the ongoing development of the inspector. Hence there is a form for a personal action plan that should be completed by each trainee during the course. As a result of the various modules, individuals will identify specific objectives that they wish to take back to their workplace. Objectives should be developed in the SMART format: Specific, Measurable, Action-oriented, Realistic and Time-related.
The columns for objective and actions should be completed during the course, and may need the help of the trainer or other members of the training team. If possible, the columns for responsibility and due date should also be completed, although these may need to wait until the trainee has discussed the objective with his/her supervisor and colleagues. These action plans should then be transferred onto evaluation forms and used to monitor progress over time. They can be used as part of formal appraisal meetings by the supervisor of the participants, if appropriate.
The traineesí binder consists of the following materials:
The objectives of the module are covered by the first couple of transparencies in all cases. The handouts include copies of all transparencies without the speakerís notes, with space for the traineeís own notes. They also include copies of WHO texts on GMP (See Bibliography). If felt to be appropriate, the complete speakersí notes can be handed out as a reference document but this should only be done after the module is completed and not in advance.
The test papers are the same as those provided in the trainerís binder, except that the answers have been removed from the texts.
The forms for Personal Action Plan and Evaluation Form are identical to those provided in the trainerís binder.
Schedule of Modules
The modules that make up each training programme are shown above. Each module stands alone and hence a course can be made up in any order. However, it is recommended that the Basic Principles of GMP be presented before GMP Inspection Process. Additional training modules on HVAC, Validation, Inspecting Quality Control Laboratories, and Water for Pharmaceutical Use are also available. If the latter is presented alone, a basic understanding of GMP should be a pre-requisite for attending the course.
Depending on the number of trainees on the course. The number of groups and hence the time required for the feedback sessions will vary. The shorter time will be appropriate for up to 25 participants and the longer time for up to 50 participants. Times given for the presentations are approximate. Trainers should present the materials by adding practical examples where possible.
The following documents have been used as the basis of the course material:
Quality assurance of pharmaceuticals Ė A compendium of guidelines and related materials Volume 1, Geneva, World Health Organization, 1997
Quality assurance of pharmaceuticals Ė A compendium of guidelines and related materials Volume 2: Good manufacturing practices and inspection, Geneva, World Health Organization, Updated edition, 2004
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-Ninth Report, Geneva, World Health Organization, 2005 (WHO Technical Report Series, No. 929)
Annex 2: Good Manufacturing Practices: requirements for the sampling of starting materials (amendment)
Annex 3: WHO Good Manufacturing Practices: water for pharmaceutical use
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Fortieth Report, Geneva, World Health Organization, 2006 (WHO Technical Report Series, No. 937)
Annex 2: Supplementary guidelines on GMP for heating, ventilation and air-conditioning systems
Annex 3: Good manufacturing practices: supplementary guidelines on GMP for the manufacture of herbal
Annex 4: Good manufacturing practices: validation
Additional Reading Material
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-third Report, Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834)
Annex 3: Good Manufacturing Practices for biological products
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth Report, Geneva, World Health Organization, 1996 (WHO Technical Report Series, No. 863)
Annex 7: Good Manufacturing Practices: supplementary guidelines for the manufacture of investigational pharmaceutical products for studies (clinical trials) in humans
WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-sixth Report, Geneva, World Health Organization, 2002 (WHO Technical Report Series, No. 902)
Annex 8: Quality systems requirements for national good manufacturing practices inspectorates
Publications Obtainable From:
World Health Organization
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