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Information on Inspections

  Good Manufacturing Practices (GMP) and inspections of manufacturing sites

The World Health Organization (WHO) inspects manufacturers of Finished Pharmaceutical Products and Active Pharmaceutical Ingredients for compliance with the current Good Manufacturing Practice (GMP) for production, packaging, quality control and related activities, prior to listing products as being prequalified. The inspections examine global adherence to GMP and are usually related to the product dossiers submitted for assessment within the prequalification program. Only the sites found to be operating to an acceptable level of compliance with GMP are listed.  

Inspected sites

When a manufacturing site is located in a highly regulated country such as an ICH country or equivalent, and has been inspected by a stringent official inspectorate, the compliance with GMP (in terms of the legislation of the relevant country) is generally accepted on the basis of the documentary evidence provided.  This includes the current manufacturing license and a WHO type Certificate of a Pharmaceutical Product as issued by the respective National Drug Regulatory Authority.  These manufacturing sites are not listed in our list of inspections performed (see below link). An inspection by WHO is performed in cases where the product is licensed and manufactured for export purposes only.   If found necessary after a risk assessment, all manufacturing sites outside the above-mentioned countries can be inspected by WHO.

WHO Public Inspection Reports (WHOPIR)

After each satisfactory inspection a summary of the inspection report is prepared. This is called a WHO Public Inspection Report (WHOPIR).  The WHOPIR is communicated to the manufacturer for agreement prior to publishing it in the public domain.  Once the agreement is obtained from the manufacturer, the WHOPIR is published on the WHO prequalification web page.

Inspectors

WHO GMP Inspections are usually performed by a team of inspectors including, but not restricted to:

  1. A GMP inspector from one of the stringent Drug Regulatory Authorities (ICH countries or equivalent) qualified by WHO based on his/her personal expertise (usually the lead inspector of the team);
  2. A WHO representative (trained and experienced as a GMP inspector);
  3. Inspectors from the National Drug Regulatory Authority of the country in which the manufacturing site is located are invited to participate in the inspection (as observers).

References

Good Clinical Practice (GCP) inspections at CROs, bioequivalence centres or research laboratories

WHO inspects the bioequivalence/clinical studies performed at Contract Research Organizations (CROs), bioequivalence centres or research laboratories for compliance with current Good Clinical Practices (GCP) prior to listing products as being prequalified Inspections examining global adherence to GCP of the bioequivalence studies are usually related to the product dossiers submitted for assessment within the prequalification program. CRO inspections are study specific, if not otherwise mentioned in the Scope of inspection.

Summary of the outcome of GCP inspections at CRO's, bioequivalence centres and research laboratories

Only CROs, bioequivalence centres or research laboratories meeting GCP requirements are included in the list of Inspections performed. Prior to listing, all the observations listed in the inspection report must be addressed and brought to a satisfactory level of compliance.  

It must be noted that other CROs, bioequivalence centres and research laboratories have also been inspected to date. These are not listed here as the inspections are not yet closed or because they do not yet comply with GCP requirements. 


References