Guide to Good Manufacturing Practice for Medicinal Products
The PIC/S GMP Guide is harmonised with EU GMP and serves as the reference GMP standard for all PIC/S participating authorities. Forms the basis for mutual recognition agreements between regulatory authorities globally.
What this does not cover
stated in the document's own scope- Covers GMP for medicinal products and their active substances; medical-device and other product-specific GMP sit in their own frameworks.
- Is a harmonised reference text, not a self-standing law; the binding requirement is the national instrument that adopts it.
- Sets manufacturing GMP, not the good-distribution-practice standard for wholesale distribution, which PIC/S covers in a separate GDP guide (PE 011).
Always verify against the current published text before relying on it for a submission or inspection.
Overview
PIC/S PE 009 is the Guide to Good Manufacturing Practice for Medicinal Products maintained by the Pharmaceutical Inspection Co-operation Scheme. It is the harmonised GMP text that all PIC/S participating authorities apply, and it is kept aligned with EU GMP so that the two read almost identically. The Guide sets out the GMP for medicinal products across a main text and a series of annexes — from the quality system and personnel through premises, documentation, production and quality control — and serves as the common reference against which PIC/S inspectorates assess manufacturers. It underpins mutual co-operation and recognition between the participating authorities.
Scope & applicability
Pharmaceutical manufacturers in all 57 PIC/S member countries. Practically equivalent to EU GMP — used when manufacturing for markets outside the US and EU.
Legal basis & how it acquires force
PE 009 is a PIC/S document, not a statute: PIC/S is a co-operative arrangement between inspectorates, and the Guide itself has no direct legal force. It acquires force when a participating authority adopts it into national law — as Australia does through its Manufacturing Principles, for example. The version identifier (for example PE 009-16) tracks successive revisions. So a manufacturer complies with the national instrument that enacts the Guide, while PE 009 supplies the harmonised technical content those national frameworks share.
Document structure
| Part | Covers |
|---|---|
| Part I — basic requirements for medicinal products | The quality system, personnel, premises and equipment, documentation, production, quality control, and complaints/recall |
| Part II — active substances | Basic requirements for active substances used as starting materials (aligned with ICH Q7) |
| Annexes — specialised manufacture | Sterile products, biologicals, and other specialised product types |
| Annexes — systems and validation | Computerised systems, qualification and validation, and related cross-cutting controls |
| Glossary | Defined terms used throughout the Guide |
Key requirements
- All EU GMP requirements are adopted by reference through PIC/S harmonisation
- Additional national annexes may apply depending on the specific PIC/S member country
- Inspection reports shared between PIC/S members — single inspection accepted by multiple authorities
Revision notes
Updated July 2023. Incorporates EU GMP Annex 1 (2022) and latest EU GMP revisions.
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
PE 009 is kept harmonised with the EU GMP Guide, so its Part I, Part II and annexes correspond closely to the EU text and, through Part II, to ICH Q7. Because the PIC/S participating authorities include regulators across Europe, the Americas, Asia and Australia, the Guide is effectively the common GMP reference internationally, and it is the basis on which participating authorities co-operate and recognise each other’s inspection outcomes.
PIC/S PE 009-16: frequently asked questions
Quick answers to common questions about PIC/S PE 009-16.
What is PIC/S PE 009?
It is the PIC/S Guide to Good Manufacturing Practice for Medicinal Products — the harmonised GMP text all PIC/S participating authorities apply, kept aligned with EU GMP so the two read almost identically.
Is the PIC/S GMP Guide legally binding?
Not by itself. PIC/S is a co-operative arrangement, so the Guide has no direct legal force; it becomes binding when a participating authority adopts it into national law — as Australia does through its Manufacturing Principles.
How does PE 009 relate to EU GMP?
They are deliberately kept harmonised, so PE 009’s main text and annexes correspond closely to the EU GMP Guide, and its Part II on active substances aligns with ICH Q7.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.