WHO Public Inspection Reports (WHOPIRs)

Introduction

A WHO public inspection report (WHOPIR) is a summary of the report of an inspection of:

  • a manufacturing site of active pharmaceutical ingredients (APIs)
  • a manufacturing site of finished pharmaceutical products (FPPs)
  • a bioequivalence or other clinical study -- performed in relation to an FPP submitted for prequalification -- by a contract research organization (CRO)
  • a quality control laboratory (QCL).

Each WHOPIR gives the date and duration of the inspection to which it refers, describes its scope, and summarizes its observations and findings. However, WHOPIRs exclude confidential proprietary information and are posted on this website only with the agreement of the manufacturer, CRO or QCL concerned and only in the event that the manufacturing site, study or QCL passed the inspection. WHOPIRs are not developed or posted on this website with respect to inspections for which the result is negative.

If a manufacturing site has been inspected several times, only the WHOPIR of the most recent inspection is available on this website.

CRO inspections are study-specific. The relevant WHOPIR summarizes the results of different, successive inspections. It will include the dates of inspection for each study and list the studies that were accepted.

Manufacturing sites and activities at those sites may undergo change. All users of the WHO List of Prequalified Medicinal Products and/or the WHO List of Prequalified Active Pharmaceutical Ingredients and/or 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 this page for three years, after which it is moved to the Archived WHOPIRs section.

Copies of the complete inspection reports can be requested from the relevant individual manufacturer, CRO or QCL.

Manufacturers of Active Pharmaceutical Ingredients (APIs)

Manufacturers of Finished Pharmaceutical Products (FPPs)

Contract Research Organizations (CROs)

Quality Control Laboratories (QCLs)

Pre-submission audits (FPPs)