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.
What this does not cover
stated in the document's own scope- Covers GMP for excipients; GMP for active pharmaceutical ingredients is the subject of ICH Q7, which excludes excipients.
- Addresses manufacture; the distribution of excipients is covered by IPEC’s separate Good Distribution Practices guide.
- Is a consensus industry standard, not a regulation — its force is contractual and through supplier qualification, not statutory.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
The Joint IPEC-PQG Good Manufacturing Practices Guide for Pharmaceutical Excipients is the reference GMP standard for the manufacture of pharmaceutical excipients — the inactive ingredients that make up most of a dosage form. It was produced jointly by the International Pharmaceutical Excipients Council (IPEC) and the Pharmaceutical Quality Group (PQG), and Version 5 (2022) is structured on the ISO 9001:2015 quality-management framework with excipient-specific GMP requirements layered on top of each clause. It is the standard an excipient supplier is realistically audited against, translating pharmaceutical GMP thinking into the reality of chemical, mineral, and food-adjacent manufacturing.
Scope & applicability
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.
Legal basis & how it acquires force
The IPEC-PQG Guide is an industry consensus standard, not a statute — it has no independent legal force. Its authority is practical and contractual: excipient GMP is a recognised expectation in pharmaceutical supply, and this guide is the common reference used in supplier qualification, audits, and quality agreements. It exists because ICH Q7 — the GMP guide for active pharmaceutical ingredients — explicitly does not cover excipients, leaving a gap that the IPEC-PQG Guide fills for the excipient supply chain.
Document structure
| Part | Covers |
|---|---|
| Quality management system | The ISO 9001-based management framework adapted for excipient manufacture |
| Management responsibility and resources | Leadership, quality policy, and the resources and personnel supporting excipient GMP |
| Product realisation | Manufacturing, change control, and the excipient-specific controls layered onto the process |
| Measurement and improvement | Monitoring, control of nonconforming product, and corrective and preventive action |
| Excipient-specific GMP requirements | The added expectations distinguishing excipient GMP from a general ISO 9001 system |
Key requirements
- 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
Implementation tips
- Write the GMP starting point into the quality agreement explicitly — disagreement about where GMP begins in an excipient process is the most common audit dispute
- Treat identity testing on receipt as non-negotiable for excipients with an adulteration history, regardless of supplier certification
- Audit the manufacturing site, not the distributor: a certificate of analysis reissued by a trader evidences nothing about how the material was made
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
The Guide is deliberately built on ISO 9001:2015 so that excipient makers already certified to it can extend rather than rebuild their system. It is positioned as the excipient counterpart to ICH Q7 for actives, and it aligns with the wider expectation — reflected in EU GMP and FDA guidance — that finished-product manufacturers assess and control excipient risk. IPEC also maintains related guides (for example on excipient GDP and significant change) that complement it.
IPEC-PQG GMP Guide (v5, 2022): frequently asked questions
Quick answers to common questions about IPEC-PQG GMP Guide (v5, 2022).
Why does a separate excipient GMP guide exist?
Because ICH Q7, the GMP guide for active pharmaceutical ingredients, explicitly does not cover excipients. The IPEC-PQG Guide fills that gap, setting GMP expectations for the inactive ingredients that make up most of a dosage form.
What is the IPEC-PQG Guide based on?
Version 5 (2022) is structured on the ISO 9001:2015 quality-management framework, with excipient-specific GMP requirements layered onto each clause so a supplier can extend an existing ISO 9001 system rather than build a new one.
Is the IPEC-PQG Guide legally binding?
No. It is an industry consensus standard with no independent legal force. Its authority is contractual and practical — it is the reference used in excipient supplier qualification, audits, and quality agreements.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.