Good Manufacturing Practices (GMP) WHO
Training workshops on Good Manufacturing Practices (GMP)
WHO presents training workshops and
seminars on the assessment of compliance with GMP at manufacturing sites. WHO
GMP guidelines are available online and on CD-ROM.
If you require more information, please contact the WHO Representative in your
country, your WHO Regional Office or WHO Headquarters in Geneva.
Please note that the WHO GMP training modules are currently
under revision. The modules below do not reflect in
all cases the current revised WHO GMP texts - as these have
The revised modules which will include the correct texts and
references should be available shortly.
The training material is
Basic and supplementary GMP Training
This training package covers material on general GMP
including norms and standards for Premises, Equipment, Materials,
Documentation, Personnel, Validation and other aspects.
Training notes on GMP:
Good manufacturing practice (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;
incorrect labels on containers,
which could mean that patients receive the wrong medicine;
insufficient or too much active
ingredient, resulting in ineffective treatment or adverse effects.
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 each 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 manufacturing process - every time a product is made.
WHO has established detailed
guidelines for good manufacturing practice. Many countries have formulated their
own requirements for GMP based on WHO GMP. Others have harmonized their
requirements, for example in the Association of South-East Asian Nations
(ASEAN), in the European Union and through the Pharmaceutical Inspection
Why is GMP important?
Poor quality medicines can damage health
Poor quality medicines are not only
a health hazard, but a waste of money for both governments and individual
GMP helps boost pharmaceutical export opportunities
A poor quality medicine may contain
toxic substances that have been unintentionally added.
A medicine that contains little or
none of the claimed ingredient will not have the intended therapeutic
Is GMP necessary if there is a quality control laboratory?
Most countries will only accept
import and sale of medicines that have been manufactured to internationally
Governments seeking to promote
their countries' export of pharmaceuticals can do so by making GMP mandatory
for all pharmaceutical production and by training their inspectors in GMP
Can manufacturers afford to implement GMP?
Yes. Good quality must be built in
during the manufacturing process; it cannot be tested into the product
afterwards. GMP prevents errors that cannot be eliminated through quality
control of the finished product.
Without GMP it is impossible to be
sure that every unit of a medicine is of the same quality as the units of
medicine tested in the laboratory.
Yes. Making poor quality products
does not save money. In the long run, it is more expensive finding mistakes
after they have been made than preventing them in the first place. GMP is
designed to ensure that mistakes do not occur.
Implementation of GMP is an
investment in good quality medicines. This will improve the health of the
individual patient and the community, as well as benefiting the
pharmaceutical industry and health professionals.
distributing poor quality medicines leads to loss of credibility for
everyone: both public and
private health care and the manufacturer. WHO works to strengthen GMP.