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CD-ROM on WHO Basic Training
Modules on GMP
A resource and study pack for trainers
CD-ROM on WHO Supplementary Training
Modules on GMP: Validation, Water, and
Air Handling Systems
This CD-ROM is intended to support the creation of
training courses on Good Manufacturing Practices
(GMP), particularly courses for inspectors of manufacturing
facilities which produce medicines or pharmaceutical
starting materials. The CD-ROM may also be
useful as a self-study guide for the inspectors themselves,
or anyone else interested in the manufacture
of quality medicines. The content of the CD-ROM is
based on a modular training course designed by staff
of the World Health Organization in collaboration
with a team of international experts in the subject.
Details of the project that produced this course are
to be found on the CD-ROM itself (in two formats -
Microsoft Word and Adobe Acrobat, in the files
'IntroAckn.doc' and 'IntroAckn.pdf' respectively, in the
'Project' folder). There are twenty modules in the
course. Fourteen of these cover Basic Principles of
GMP, five cover the GMP Inspection Process, and the
final module covers setting up and running a training
course on GMP. The CD-ROM contains a set of the
Microsoft PowerPoint presentations, together with
handouts and other supporting material (these latter
again in both Word and Acrobat formats), together
with utilities for viewing or printing these. The CD-
ROM also contains a software tool (installed by running
'Setup') to help trainers modify the course to
better fit local conditions and regulations. This contains
the full text of the presentations in a searchable
database, together with examples of speaker's notes,
and action-setting and note-taking facilities, and
options for printing these. The tool also provides
access to an introductory video on GMP, which lasts
18 minutes and has been optimised for viewing
on-screen.
The Supplementary Training Modules on Good
Manufacturing Practices (GMP) are a product of the
WHO/EDM Strengthening of Pharmaceutical
Manufacturing Inspection (SPMI) Project. The aims
of the project were to strengthen pharmaceutical
manufacturing inspectorates by promoting the use
of the previously developed training package entitled:
WHO Basic Training Modules on GMP, through the
setting up of international workshops using the
materials, and by undertaking global distributions
of the Basic Training Modules CD-ROM, issued in
April 2001. The SPMI project concluded at the end
of March 2003.
In response to the many requests that were received
back from individuals who had either attended a
workshop or who had used the CD-ROM, three
supplementary modules were developed on topics that
had been specifically asked for, namely:
• Validation (including Cleaning, Process,
and QC-related Validation)
• Water for Pharmaceutical Use, and
• Air Handling Systems.
The materials, which comprise PowerPoint slide
presentations, tutorial notes, group session exercises,
and question and answer papers, are intended to
support the creation of training courses primarily
for government compliance officers who inspect
manufacturing facilities that produce medicines or
pharmaceutical starting materials. The training
package may also be useful as a self-study guide
for these inspectors, or anyone else interested in the
manufacture of quality medicines.
15
2001, CD-ROM [E]
WHO/EDM/QSM/2000.7
Available Free of Charge
Order no. 1990012
2003, CD-ROM [E]
WHO/EDM/QSM/2002.5
Available Free of Charge
Order No. 1992012