Risk Management Principles used for WHO Inspections of API facilities

The WHO Pharmaceutical Newsletter No 1, 2011 reported about inspections of API facilities performed by or on behalf of WHO. These inspections are necessary because all APIs used in pre-qualified medicinal products have to comply with GMP. The applicable standard for these inspections is ICH Q7 "GMP for APIs" as WHO has incorporated this standard in the WHO norms and standards

The programme was initiated in 2003. In order to select the sites the WHO is using risk management principles to select facilities, to define the duration of the inspection and the frequency. The following table explains the risk classification made. This table may also be of interest for pharmaceutical companies in order to define priorities for their own programme.


 In total 126 API sites are participating in the WHO programme. The WHO also considers inspections by other organisations such as EDQM, as well as inspections from PIC/S countries and US FDA. Therefore 49 API sites were accepted based on approval by PIC/S Inspectorates and/or ICH countries and 31 facilities were inspected by WHO Inspectors. According to the WHO Newsletter Six of the inspected sites were found to operate at an unacceptable level of compliance with WHO GMP. The following graphic shows which deviations have been identified during these inspections.


Source: WHO Newsletter No 1, 2011

WHO Technical Officer Dr Antony Fake will present the WHO Prequalification Programme of APIs at the 4th European GMP Conference on 19/20 May 2011 in Heidelberg

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