Quality & GMP Readiness

CURRENT · WORLD HEALTH ORGANIZATION

Generic Medicines — WHO Prequalification Readiness

WHO identifies API and FPP quality, bioequivalence and manufacturing-site GMP requirements for full assessment of multisource FPPs. Related CRO inspection may be needed.

WHO guidance uses the modular Common Technical Document structure. Exact dossier and evidence requirements remain product-specific.

Product eligibility
API readiness
FPP quality
Bioequivalence
GMP / manufacturing site readiness
Product dossier
WHO prequalification process

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Independent professional support pathways. Pharma Gate does not assess eligibility, certify suppliers or submit applications to WHO.

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National market authorization remains separate from WHO prequalification.

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Official facts are attributed to the issuing organization. Pharma Gate interpretation and recommended actions are separate editorial layers, not legal requirements or regulatory approval. Sources are prioritized: national regulators, WHO and recognized intergovernmental bodies, official procurement organizations, then other official governmental or institutional sources.

Publication records retain source title, version, issue date, verification date, country, sector and status. Draft / Public Consultation is distinct from Current. Superseded and Archived records do not represent current requirements. A verification date records the review performed; it is not an assurance of continuous monitoring. Always check the latest official source before acting.