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News about GMP/cGMP

WHO Report: Inspections of API Manufacturers

Recently the WHO (World Health Organization) issued the first "Pharmaceuticals Newsletter" in 2011. It contains an interesting Report on WHO Inspection Activites of API (Active Pharmaceutical Ingredients) Manufacturers.


API manufacturing site inspections were started in 2003. An inspection team normally consists of a WHO inspector based in Geneva and a co-inspector appointed by the WHO from a Pharmaceutical Inspection Cooperation Scheme (PIC/S) member inspectorate. An inspector (or inspectors) from the National Drug Regulatory Authority of the country, in which the manufacturing site is located is invited to participate as an observer.


Out of 126 API sites participating in PQ activities, 49 were accepted based on approval by PICS inspectorates and/or ICH countries, while 31 were inspected by WHO inspectors. Six of the inspected sites were found to operate at an unacceptable level of compliance with WHO GMP.

Key Observations of API inspections

Deficiencies observed during inspections of API sites have been mainly in materials management, documentation, cleaning and cross-contamination.


You can download the WHO "Pharmaceuticals Newsletter", Issue 1/ 2011. You find the complete report at page 12 et seqq.


WHO/ Newsletter

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