WHO Technical Report Series, No. 981 - World Health Organization

6. Quality assurance – good manufacturing practices
6.1 Updates of WHO GMP texts
In 2011 the Expert Committee approved updates to three GMP texts. The
secretariat reported that no proposals for updating of GMP materials had been
received since then. It was noted, however, that a number of European Union (EU)
and United States Food and Drug Administration (US-FDA) GMP guidelines
had been recently updated.
The Expert Committee requested the secretariat to make a proposal on
how to revise the WHO guidelines in light of these trends in other new guidelines.
6.2 Training materials
The process for the revision of the WHO training modules was approved by
the Expert Committee in October 2011 to bring them in line with the updated
guidelines. Each slide of the modules was therefore checked for correctness in
relation to the various revised GMP texts. All basic training modules had been
revised and updated and were being reviewed. Major changes were made to the
GMP training modules, e.g. for the module on quality management, to include
risk assessment and other new factors. The Expert Committee was informed
that there was currently no training material on microbiology laboratories and
hazardous materials as these GMP texts had only been developed in recent years.
A number of other training modules were still under revision. It was noted that
all WHO GMP guidelines are to be provided on a CD-ROM.
The Expert Committee expressed its gratitude for the update.
21