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In pharmaceuticals and biotech, what decides is a fourth role separate from the healthcare-service / medical-device / laboratory triad in Healthcare: manufacturing or supplying the medicinal product itself, an excipient, or its primary packaging material. Your role in the supply chain — manufacturer, excipient supplier, packaging manufacturer — changes the candidate record set.
It is a sector-specific application of ISO 9001 for primary packaging materials for medicinal products and incorporates Good Manufacturing Practice (GMP) requirements; it does not substitute for a marketing authorisation or a GMP inspection.
It is a GMP/GDP certification scheme for pharmaceutical excipients; NSF/IPEC/ANSI 363 is a comparable excipient GMP scheme based on the same IPEC-PQG guideline. WHO GMP and PIC/S sit in a separate category: they are not schemes that certify companies but cooperation and inspection frameworks between regulatory authorities.
No verified candidate standards are mapped to this sector yet.
These are not ISO standards; each has its own scheme owner, issuing body and rules. Whether they are candidates is decided by activity and buyer requirement.
PSCI is a non-profit membership organization whose members share third-party supplier audits across the pharmaceutical and healthcare value chain.
Rx-360 is a pharmaceutical supply-chain consortium that runs shared supplier audits and licenses the resulting reports to its members.
Last verified:
This page is for information only; it is not legal advice. A record appearing here does not mean it is required for your business. This library does not issue certificates.
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"Pharmaceuticals and Biotech." Certifidex, FutureTechnologies. Last verified 23 August 2026. https://certifidex.com/sectors/pharmaceuticals-and-biotech