International Pharmaceutical Excipients Council
Federation of regional excipient councils; co-publisher with the PQG of the excipient GMP guide that fills the gap ICH Q7 leaves for excipient makers.
WHAT IPEC COVERS
The International Pharmaceutical Excipients Council is a federation of regional excipient associations — IPEC-Americas, IPEC Europe, JPEC in Japan, and the Chinese and Indian councils — representing both excipient makers and the pharmaceutical companies that use them. Its central output is the Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients, published with the UK Pharmaceutical Quality Group, currently version 5 (2022) and rebuilt on the ISO 9001:2015 clause structure with excipient-specific GMP layered on top.
WHERE IT SITS INTERNATIONALLY
The IPEC-PQG guide is aligned to ISO 9001:2015 and sits deliberately below ICH Q7 in rigour, reflecting where excipients are actually made. It connects upward to the regulatory obligation that does bind: EU GMP Part I Chapter 5 requires manufacturing authorisation holders to establish excipient GMP through a formalised risk assessment, and the European Commission's 2015 guidelines on that assessment are the instrument that gives excipient GMP legal traction in Europe. For SPEQ's excipient-suppliers sector this is the anchor document, and the pairing to hold in mind is that the guide states what good looks like while the risk assessment is what makes the buyer responsible for confirming it.
HOW ITS REQUIREMENTS BITE
Adoption through the purchaser. IPEC has no regulatory authority, runs no inspection programme, and certifies nobody. Excipient GMP is enforced commercially: it appears in the quality agreement, it is verified in the supplier audit, and it is the pharmaceutical manufacturer — accountable for its own materials under ICH Q7 and EU GMP Part II — that carries the regulatory consequence when it is absent. That is an unusual mechanism, and it is why excipient quality tends to be as good as the customer's audit programme and no better.
WHAT IPEC PUBLISHES
- 01The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients (version 5, 2022) — the reference an excipient supplier is realistically audited against
- 02The IPEC Good Distribution Practices Guide for Pharmaceutical Excipients, covering the trader and distributor layer
- 03Excipient composition, significant-change, and qualification guides used to structure supplier assessment
- 04Guidance on excipient risk assessment and on the pharmaceutical manufacturer's own excipient controls
- 05Position papers on excipient regulation and on the emerging expectations for novel excipients
WHAT PRACTITIONERS GET WRONG
- ›ICH Q7 covers active substances, not excipients — the IPEC-PQG guide exists precisely to fill that gap, and citing Q7 at an excipient maker is a category error.
- ›Excipients are commonly made on multi-purpose plant serving food, cosmetic, and industrial customers, so full pharmaceutical GMP is neither proportionate nor achievable; the guide is calibrated to that reality and setting the wrong expectation wastes an audit.
- ›IPEC has stated that earlier versions are obsolete. An audit programme still working from the 2017 text is auditing against a superseded document.
- ›Audit the manufacturing site, not the distributor. A certificate of analysis reissued by a trading company evidences nothing about how the material was actually made, and the diethylene glycol adulteration cases turn on exactly that gap.
- ›Change notification is the clause most often found unmet, and the one that matters most: an excipient change the user never hears about surfaces as an unexplained process deviation months later.
IPEC STANDARDS SPEQ DECODES · 1
DISCIPLINES IN IPEC’S REMIT
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