WHO Public Inspection Reports (WHOPIRs)
A WHO Public Inspection Report (WHOPIR) is a publicly available summary of the report of an on-site inspection or of a desk assessment indicating that the site or study is compliant with international standards and norms and in adherence with dossier information.
Public inspection reports are published on this WHO Prequalification webpage for transparency purposes and as a result of 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".
WHOPIRs are published in relation to inspection or desk assessment of the following product types and related manufacturing sites:
- immunization devices (although WHO Public Inspection Reports are not available for these products on this website) and related manufacturing sites, and product testing laboratories
- in vitro diagnostic and male circumcision device related manufacturing sites
- related API manufacturing sites and FPP manufacturing sites
- bioequivalence or other clinical studies performed by contract research organizations in relation to FPPs submitted for prequalification
- vaccine manufacturing sites
- vector control product manufacturing sites.
Each WHOPIR provides the date and duration of the inspection or desk assessment to which it refers, describes the scope, product(s), facilities and on-site operations and summarizes inspection or desk assessment observations and findings. However, WHOPIRs exclude confidential proprietary information and are posted on this webpage only with the agreement of the manufacturer/CRO/laboratory.
WHOPIRs are used to provide information on a site that is deemed compliant with international standards and norms. Inspection Services will publish a Notice of Concern (NOC) if a site does not meet international standards and norms, following the completion of the inspection process and will remove from this webpage any WHOPIR that was published following a previous inspection of this site.
If a manufacturing site or laboratory has been inspected several times, only the WHOPIR of the most recent inspection is available on this webpage.
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.
Unless otherwise specified, each WHOPIR remains on this page for three years (1), after which it is moved to the Archived WHOPIRs section. It is noted that the WHOPIR reflects the status of the site at the time of the inspection and therefore it is advised to verify with the site that no significant changes have taken place since the WHO Prequalification inspection.
Please note that acceptance of compliance with the WHOPIR does not represent prequalification of the site and does not necessarily mean that the products covered have been approved by WHO Prequalification. Prequalification is only indicated by a product appearing in the prequalified product lists:
- immunization devices catalogue
- in vitro diagnostic products and male circumcision devices
- vector control products
Note: A WHOPIR is the property of the World Health Organization and may not be copied, reproduced, abstracted, edited, translated, distributed or used in any way, without the prior written authorization of WHO. In no event may this report be used for any commercial and/or promotional purposes. Copies of the complete inspection reports can be requested from the relevant individual manufacturer, CRO or QCL.
(1) As part of regulatory flexibilities taken in response to the COVID-19 pandemic, all WHOPIRs published since 2018 onwards will remain on this webpage, provided that the sites are still considered to be GMP compliant and/or that it was not replaced by a more recent WHOPIR on this webpage. Further to this, the approach is taken as a result of a significant reduction in the number of onsite inspections being performed, due to travel restrictions resulting from the COVID-19 pandemic. This regulatory flexibility will be applied until full resumption of onsite inspection activities by WHO PQT: Inspection Services and may be revoked without further notice.