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 trainer’s binder and the trainees’ binder.

Trainer's Binder

      The trainer’s binder consists of the following items:  

 Objectives of module
 Transparencies and speaker’s 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 speaker’s 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 speaker’s notes, with space for the trainee’s 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 trainer’s 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 trainer’s 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.