Last autumn, the WHO started a programme for the pre-qualification of APIs which completes the already existing pre-qualification programme for medicinal products (see our News vom 28 October 2010). The aim of this programme was to assure the high quality of APIs and medicinal products destined for the use in third world countries especially. It covers APIs for the manufacture of pharmaceuticals against HIV/AIDS, Malaria, Tuberculosis, Influenza, pharmaceuticals for reproductive health as well as zinc sulphate.
The WHO has recently published a Newsletter where it describes its risk-based approach of API inspections and presents a set of statistics based on both inspections which have already been performed and on upcoming inspections.
Basically, the following conditions prevail for the pre-qualification programme (PQP):
A PQP inspection is not necessary in following cases:
Independently from the cases mentioned above, the WHO reserves itself the right to perform an inspection anytime based on risk considerations.
The WHO Newsletter contains interesting information about inspection statistics:
Also interesting is the presentation of the most frequent GMP deviations: the front runners are deviations in equipment management and documentation as well as insufficient cleaning. The following chart illustrates the frequency distribution of GMP deviations:
Please also see the WHO Newsletter.
Note: the courses on "ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis/Cell Culture/Fermentation" taking place in Vienna, Austria, from27-29 June 2011 will cover in detail the topics mentioned above. The final "ICH Q7 Auditor Training Course" also in Vienna from 29 June - 1 July 2011 (which will be repeated on 26 - 28.10.2011 in Heidelberg) provides excellent training on the techniques to be used during an audit.
Antony Fake from WHO will talk about the programme at the 4th European GMP Conference in Heidelberg.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)