Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients
The joint IPEC Federation and Pharmaceutical Quality Group guide setting GMP expectations for excipient manufacture. Version 5 (2022) is structured on ISO 9001:2015 with excipient-specific GMP requirements layered on top, and it is the reference an excipient supplier is realistically audited against.
Manufacturers and distributors of pharmaceutical excipients, and the finished-product manufacturers who audit them. Excipients sit outside the scope of ICH Q7, which covers active substances — this guide is what fills that gap.
- 01A quality system covering excipient manufacture, with defined GMP starting point in the process
- 02Documented change control with customer notification for changes affecting the excipient
- 03Traceability and distribution records sufficient to reconstruct the supply chain
- 04Supplier and distributor qualification extending to the original manufacturing site
IPEC-PQG GMP Guide (v5, 2022): frequently asked questions
Quick answers to common questions about IPEC-PQG GMP Guide (v5, 2022).
What is IPEC-PQG GMP Guide (v5, 2022)?
IPEC-PQG GMP Guide (v5, 2022) — Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients — is a guideline issued by the International Pharmaceutical Excipients Council. The joint IPEC Federation and Pharmaceutical Quality Group guide setting GMP expectations for excipient manufacture. Version 5 (2022) is structured on ISO 9001:2015 with excipient-specific GMP requirements layered on top, and it is the reference an excipient supplier is realistically audited against.
Who does IPEC-PQG GMP Guide (v5, 2022) apply to?
Manufacturers and distributors of pharmaceutical excipients, and the finished-product manufacturers who audit them. Excipients sit outside the scope of ICH Q7, which covers active substances — this guide is what fills that gap.
What are the key requirements of IPEC-PQG GMP Guide (v5, 2022)?
IPEC-PQG GMP Guide (v5, 2022) requires, among other things: A quality system covering excipient manufacture, with defined GMP starting point in the process; Documented change control with customer notification for changes affecting the excipient; Traceability and distribution records sufficient to reconstruct the supply chain; Supplier and distributor qualification extending to the original manufacturing site.
When was IPEC-PQG GMP Guide (v5, 2022) last updated?
The current version of IPEC-PQG GMP Guide (v5, 2022) dates from December 2022.
Live openFDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.
Track the standards that move
When IPEC-PQG GMP Guide (v5, 2022) — or any GxP requirement — is revised, recalled against, or clarified by new guidance, the Weekly GxP Briefing surfaces it. Free, one email a week.