WHO Supplementary Training Modules on

GMP
Validation

Water

Air Handling Systems

The Supplementary Training Modules on Good
Manufacturing Practices (GMP) are a product of the
WHO/EDM1 Strengthening of Pharmaceutical
Manufacturing Inspection (SPMI) Project, which was
set up in January 2001. Funded with the assistance
of the Government of Japan, the aims of the project
are 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
undertaking global distributions of the Basic Training
Modules CD-ROM. In response to the many
requests that were received back from individuals
who had either attended a workshop or had used the
CD-ROM, three supplementary modules were
developed on topics that had been specifically
requested, namely: Validation; Water for
Pharmaceutical Use; and Air Handling Systems.
(For further details see Trainers Notes file.)
These three modules, plus a further supplementary
module: Inspecting the QC laboratory, the latter
currently under preparation, will be made available
during 2003 on the WHO website:
www.who.int/medicines .
The materials 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.
Work on developing the Supplementary Training
Modules package (CD-ROM) began in the latter part
of 2001. As with the Basic Training Modules,
materials were developed by WHO staff in
collaboration with an international team of external
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Department of Essential Drugs and Medicines Policy
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consultants who were experts in the respective
subjects. The first drafts were completed in January
2002, and these were reviewed by WHO staff and
independent experts at an informal meeting held in
Geneva in April 2002. Subsequently, a second draft
was completed the following month. The modules
were then used at a Pilot Training Workshop held in
Viet Nam in July 2002, attended by government
pharmaceutical inspectors from eight countries from
within the WHO South-East Asia and Western Pacific
regions. The resulting third draft of the texts was
further reviewed by independent experts during
September and October 2002, the final version being
completed in December 2002.
Working Group Members of the SPMI Project:
Dr K. Morimoto (SPMI Project Coordinator);
Mrs J. Curry; Dr S. Kopp; Dr L. Rgo; Mr A. van Zyl;
Mr E. Wondemagegnehu.
WHO staff contributing to the development of the
WHO Supplementary Training Modules on GMP:
Dr A. Asamoa-Baah; Mr H. Hashizume; Dr J. Quick;
Dr Y. Suzuki.
Acknowledgements
The World Health Organization acknowledges with
gratitude the financial support to the SPMI Project
received from the Government of Japan.
WHO gratefully acknowledges the active
participation and constructive comments received
from members of the global medicines family,
including:
GMP Consultants:
Mr David Buckley (Australia); Mme Paule Jacqmain
(Belgium); Mr Paul Hargreaves (U.K);
Mr Andres Jagomgi (Estonia); Mr Alain Kupferman
(France); Mr Deryck Smith (South Africa);
Mr Masahiro Suzuki (Japan); Mr Robert Tribe
(Australia).
Member States who provided special support:
Bangladesh; China; India; Indonesia; Malaysia;
Philippines; Thailand; Viet Nam.
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 pharma-
ceutical starting materials. This is the
second CD-ROM on GMP, the first of
which covered basic principles. This
supplementary volume covers topics
requested by users of the first volume.
There are three modules in the course:
Validation, Water for Pharmaceutical
Use, and Air Handling Systems,
together with a Trainers Notes
document.
Each of these modules consists of a
number of Microsoft PowerPoint
presentations, together with tutorial
notes, group session exercises,
handouts and comprehension test and
answer sheets (these latter 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 presenta-
tions in a searchable database,
together with the graphics used,
examples of speakers notes, and
action-setting and note-taking facilities,
and options for printing these.
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
respective subjects. 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 Introduction.doc
and Introduction.pdf respectively,
located within the 'Project' folder). The
Trainers Notes document, also in MS
Word and Acrobat formats, are to be
found in files Trainers.doc and
Trainers.pdf.
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What is GMP?
GMP is a system for ensuring that
products are consistently produced and
controlled according to quality
standards.
It is designed to minimize the risks
involved in any pharmaceutical
production that cannot be eliminated
through testing the final product. The
main risks are:
unexpected contamination of
products, causing damage to health
or even death;
wrong labels on containers, leading
to the patient getting the wrong
medicine;
not enough or too much active
ingredient, resulting in ineffective
treatment or adverse effects.
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GMP covers all aspects of production;
from the starting materials, premises
and equipment, to the training and
personal hygiene of staff. Detailed
written procedures are essential for any
process that could affect the quality of
the finished product. There must be
systems to provide documented proof
that correct procedures are consistently
followed at each step in the manufac-
turing processevery time a product is
made.
WHO has established detailed
guidelines for good manufacturing
practices. Many countries have
formulated their own requirements for
GMP based on WHO GMP. Others
have harmonized their requirements,
for example members of the Associa-
tion of South-East Asian Nations
(ASEAN), members of the European
Union, and through the Pharmaceutical
Inspection Convention.
Poor quality medicines can Why are Good Manufacturing
damage health Practices (GMP) important?

A poor quality medicine may contain Poor quality medicines are not only a
toxic substances that have been added health hazard, but a waste of money for
unintentionally. both governments and individual
consumers.
In Haiti in 1996, more than 80 children
died after receiving a cough and cold
syrup containing glycerol contaminated
with diethylene glycol. If the manufac-
turer had followed GMP, these deaths
could have been avoided.

A medicine that contains little or none

of the claimed active ingredient will not
have the intended therapeutic effect.

An antibiotic with somebut not

enoughof the active ingredient will
not cure infections. Even worse,
bacteria exposed to low levels of the
antibiotic may not be killed and may
become resistant to the drug, even at
the correct dosage, putting more lives
at risk.

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Installation Instructions
This CD-ROM has been designed for
use on both PCs running Windows and
on Apple Computers running the Mac
OS. Check the file ReadMe.txt on the
CD-ROM for any late changes to these
instructions, and for a complete list of
the contents of the disk.
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Installation for Windows
To install the WHO GMP software tool
for modifying the training course,
double click the file Setup.exe and
follow the instructions for identifying a
suitable location on your hard disk.
The PowerPoint presentations can
simply be copied to your hard disk as
required, or viewed from the CD-ROM.
If you do not own Microsoft PowerPoint,
you can install a utility for viewing the
files by double-clicking the file
PPView97.exe in the folder
PPTViewer, and following the
instructions.
The Adobe Acrobat (PDF) files can
simply be copied to your hard disk as
required, or viewed from the CD-ROM.
If you do not own Adobe Acrobat, you
can install a utility for viewing the files
(Acrobat Reader) by double-clicking the
file rs405eng.exe in the folder
Acrobat, and following the instructions.
Installation for Mac OS

To install the WHO GMP software tool

for modifying the training course,
double click the file Setup.sea and
follow the instructions for identifying a
suitable location on your hard disk.

The PowerPoint presentations can

simply be copied to your hard disk as
required, or viewed from the CD-ROM.
If you do not own Microsoft PowerPoint,
you can install a utility for viewing the
files by double-clicking the file
PPT98VW.hqx in the folder
PPTViewer, and following the
instructions.

The Adobe Acrobat (PDF) files can

simply be copied to your hard disk as
required, or viewed from the CD-ROM.
If you do not own Adobe Acrobat, you
can install a utility for viewing the files
(Acrobat Reader) by double-clicking the
file Acrobat Reader 4.0 Installer in the
folder Acrobat, and following the
instructions.

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 This disk is designed to run on both Windows and Macintosh systems
Windows minimum requirements Macintosh minimum requirements
Intel compatible 486/33 or faster computer Any Macintosh, Power Macintosh or compatible
Windows 95, 98, 2000, ME, XP or NT computer
8MB RAM System 7.1 or later (Classic under OSX)
20MB hard disk space 8MB RAM
20MB hard disk space

The information contained in the CD-ROM is, unless otherwise attributed, the property of the World Health
Organization 2003 The World Health Organization. Adobe, the Adobe logo, Acrobat, and the Acrobat logo are
trademarks of Adobe Systems Incorporated. Microsoft, Windows, and Windows NT are either registered trademarks
or trademarks of Microsoft Corporation in the U.S. and/or other countries. Apple, Macintosh, Mac, and Power
Macintosh, are trademarks of Apple Computer, Inc. registered in the U.S. and other countries. All other trademarks
are the property of their respective owners. The Adobe Reader software is 1999 Adobe Systems Incorporated. All
rights reserved. The PowerPoint Viewer software and the Verdana font are 2000 Microsoft Corporation. All rights
reserved. The WHO GMP2 software (WHO_GMP2) was developed using FileMaker Pro, , and therefore portions of
the package are Copyright 1999 FileMaker, Inc. (www.filemaker.com). The interface, additional scripting and all
other parts of the software tool otherwise unattributed are 2002 Informart Limited. All rights reserved. USER
WARNING: This tool contains passwords which can only be provided by Informart Limited. This file is not
customizable. Contact Informart Limited for information about customizing this solution (GMP2@informart.co.uk)

WHO works to strengthen GMP

WHO can assist countries that want to strengthen World Health Organization
GMP. Guidelines and training materials are available, Quality Assurance and Safety: Medicines
and technical support may also be given. If you want Essential Drugs and Medicines Policy
to know more, please contact the WHO Representa- 20 Avenue Appia, 1211 Geneva 27, Switzerland
tive in your country, your WHO Regional Office or Fax: +41 22 791 4730
WHO Headquarters in Geneva. E-mail: GMP@who.int

2003, World Health Organization

WHO/EDM/QSM/2002.5