The World Health Organization’s API Prequalification (API PQ) evaluates whether an active pharmaceutical ingredient is of good quality and whether its manufacturing site(s) comply with WHO GMP. Evaluation has two components: (1) assessment of the API Master File (APIMF) against WHO norms and standards, and (2) verification that the manufacturing site(s) meet WHO GMP requirements. API PQ is a stand-alone procedure (distinct from an FPP PQ application).
If an API and its site(s) meet prequalification requirements, WHO lists the API on the public List of Prequalified Active Pharmaceutical Ingredients and issues a Confirmation of API Prequalification (CoPQ) to the manufacturer. The listing signals that the API is “acceptable, in principle” for use in the manufacture of FPPs procured by UN agencies.
The APIMF is the dossier that the WHO assesses to determine API quality. It follows CTD M4Q structure and is submitted in two parts, Open (Applicant’s) Part and Restricted (Confidential) Part, covering manufacturing process, controls, specifications, and stability, among other elements.
WHO also provides specific guidance on APIMF amendments (e.g., when data changes or updates are required), including expectations for content and categorization, which is important for keeping the APIMF aligned with WHO’s records. Analytical characterization supporting APIMF sections, such as specifications, stability, and impurities, is supported through advanced analytics.
WHO may conduct a full or abridged assessment of the APIMF, depending on prior regulatory evaluation history. In all cases, GMP verification of the manufacturing site(s) remains part of prequalification.
Applied when the APIMF has not previously undergone assessment by an authority applying stringent standards or under the WHO APIMF procedure. WHO performs a complete quality assessment of the APIMF along with GMP verification of the site(s). (WHO describes full vs abridged assessment at a high level and specifies the two-part evaluation of APIMF + GMP.)
If the APIMF/API has already been assessed and accepted by an authority applying stringent standards (e.g., US FDA or EDQM), WHO conducts an abridged review to avoid duplicating regulatory work. WHO reviews the SRA assessment report to confirm that the API submitted for PQ is identical to the SRA-accepted version. GMP compliance must still be demonstrated (inspection or acceptable evidence under WHO/stringent GMP).
If an APIMF was previously assessed using the APIMF procedure, WHO may perform an abridged “conversion” assessment after ensuring the APIMF on file is updated to reflect current details; WHO can still request additional data to meet PQ requirements.
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For procurement and CMC teams, a WHO-prequalified API provides a public record of quality and GMP compliance, can streamline sourcing for UN-supported programs, and can facilitate assembly of consistent CTD modules for FPP dossiers (using the APIMF + CoPQ as reference). The WHO list explicitly states that included APIs are acceptable, in principle, for use in FPP manufacture for UN procurement.
For API manufacturers preparing for PQ:
APIMF readiness: Ensure the dossier follows WHO’s required format (CTD M4Q), with both open and restricted parts complete and current.
Change management: File APIMF amendments when processes, specifications, or facilities change, following WHO’s variation categorization.
Inspection preparedness: Be ready for a WHO GMP inspection; site quality systems, production, and QC controls must demonstrate compliance.
For buyers and FPP dossier teams:
Verify listing: Confirm the API appears on the WHO List of Prequalified APIs, including product details and site(s).
Request CoPQ: Obtain the Confirmation of API Prequalification from the API manufacturer for regulatory and sourcing documentation.
Align with FPP CTD: Use the APIMF and CoPQ to ensure consistency in Module 3 (Quality) of the FPP dossier.
Q. Is API PQ mandatory for FPP PQ? No. API PQ is a stand-alone procedure. An FPP dossier can include a non-prequalified API. However, using a prequalified API can simplify FPP prequalification and reduce regulatory questions.
Q. Does the abridged assessment skip GMP? No. Regardless of the assessment route, WHO still verifies GMP compliance of the API manufacturing site(s).
Q. Does listing mean automatic approval in all markets? No. API PQ signals that WHO considers the API acceptable, in principle, for use in FPPs for UN procurement. It does not replace national regulatory approval processes.
As global health programs expand access to essential medicines, reliable APIs are central to supply security and quality assurance. WHO API PQ gives both buyers and manufacturers a transparent, globally recognized benchmark:
API prequalification is built on three elements: APIMF assessment, GMP verification, and listing/CoPQ issuance. Whether through full or abridged routes, the outcome is a public listing and official confirmation that can de-risk sourcing, strengthen dossiers, and support global procurement goals. In a concentrated API market, this independent layer of oversight is increasingly valuable for ensuring both quality and continuity.