WHO Basic Training Modules on Good Manufacturing Practices (GMP)

Basic Principles of GMP: Module 1

Introduction to the training course [1-2 hours]

Quality management [4 hours]
Sanitation and hygiene [3 hours]

Qualification and Validation [3 hours]

Complaints and recalls [4 hours]
Contract production and analysis [3 hours]
Self-inspection and Quality Audits [3 hours]
Personnel [5 hours]

Premises [4 hours]

Equipment [5 hours]
Materials [3 hours]
Documentation (1) (2) [5 hours]
Good Practices in Production and Quality Control [7 hours]
Sterile production
Active Pharmaceutical Ingredient [3 hours]

GMP Inspection Process: Module 2

Introduction [1 hour]
The role of the inspector [2 hours]
Preparation for an inspection [2 hours]
Types of GMP inspection [3 hours]
The inspection [2 hours]

Trainer's Notes
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.

Course Material
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 trainers binder and the trainees binder.

Trainer's Binder
The trainers binder consists of the following items:

Objectives of module
Transparencies and speakers notes

Worksheets
Test papers and answers

Form for personal action Plan

Form for evaluation

The objectives of the module are covered by the second transparency in each case.
The speakers 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 speakers
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.

Trainees' Binder
The trainees binder consists of the following materials:

Objectives of module
Handouts, including space for personal notes
Test papers
Proforma for Personal Action Plan
Course evaluation and feed back

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 speakers notes, with space for the trainees own notes.
They also include copies of WHO texts on GMP (See Bibliography). If felt to be appropriate, the complete
speakers 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 trainers 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 trainers
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.

Note
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.

Bibliography
The following documents have been used as the basis of the course material:
Quality assurance of pharmaceuticals A compendium of guidelines and related materials Volume
1, Geneva, World Health Organization, 1997

Quality assurance of pharmaceuticals 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
medicines
Annex 4: Good manufacturing practices: validation

Additional Reading Material

WHO
Expert
Committee
on
Specifications
for
Pharmaceutical
Preparations.
Report, Geneva, World Health Organization, 1993 (WHO Technical Report Series, No. 834)
Annex 3:
Good Manufacturing Practices for biological products

Thirty-third

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:

WHO Press
World Health Organization
1211 Geneva 27
Switzerland
Fax (41 22) 791 4806
E-mail: bookorders@who.int

Related links
GMP Supplementary Training Modules: Validation, Water, Air Handling Systems