Introduction to WHOPIRs
The World Health Organization Public Inspection Reports (WHOPIR) is a summary of the inspection report of
- a manufacturing site for Active Pharmaceutical Ingredients (APIs);
- a manufacturing site for Finished Products (FPs);
- an organization such as a Contract Research Organization where a bioequivalence study or other clinical study had been performed (CROs);
- a quality control laboratory
The WHOPIR reflects the inspection report and gives a summary of the observations and findings made during the inspection, but excludes confidential proprietary information. It indicates also the date and duration of the inspection as well as the scope of the inspection.
Manufacturing sites are subjected to periodic inspections and follow up inspections. The implementation of the corrective actions is verified by WHO by means of a documentation review or a follow-up inspection. Only when all critical or major non-compliances" with WHO GMP, GCP or other equivalent guidelines have been satisfactorily corrected by the manufacturers or organizations, the sites are published on the list and the WHOPIR are issued.
Although the manufacturing sites might have been inspected several times, only the WHOPIR of the last inspection, mentioned in the list, is available.
Regarding the CRO's, because the inspections are study specific, the WHOPIR of the CRO is built up by the results of the different successive inspections. It will mention along with a summary of the observations made during the different inspections, all the studies conducted, inspected and accepted, as well as the dates of inspection for each study.
Public inspection reports are published on this WHO Prequalification web page as WHOPIRs in response to Resolution WHA57.14 of the World Health Assembly, dated 22 May 2004, which requested the Director-General:
"...to ensure that the prequalification review process and the results of inspection and assessment reports of the listed products, aside from proprietary and confidential information, are publicly available".
Manufacturing sites and activities at those sites may undergo change. All users of the List of Prequalified Products and WHOPIRs are therefore advised to verify with the relevant manufacturer(s) that production and control activities on site have not changed since WHO inspection. Each WHOPIR remains on the web site for 3 years, after which period it is moved to the section named "Archived WHOPIRs".
