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.
Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)