PIC/S GMP Guide Part 1 is the section of the PIC/S PE 009 guide that sets out the basic GMP requirements for medicinal products: the Pharmaceutical Quality System, personnel, premises, documentation, production and quality control. If you work in QA, QC or manufacturing you will meet it in almost every international audit, because it is the text on which the inspectors of 57 Authorities around the world are trained. In this guide we look at what Part 1 is, how its 9 chapters are organised, how it differs from EU GMP Part I and how to use it to prepare for an inspection.
PIC/S GMP Guide Part 1: what it is and where it sits
PIC/S (Pharmaceutical Inspection Co-operation Scheme) is the co-operation arrangement between inspection Authorities that harmonises GMP standards and inspector training worldwide. Its core document is the GMP Guide PE 009, currently at revision PE 009-18, in force since 24 September 2026. The guide is organised in three blocks:
- Part I – Basic Requirements for Medicinal Products: the basic GMP requirements for medicinal products (finished product), organised in 9 chapters;
- Part II – Basic Requirements for Active Pharmaceutical Ingredients: the requirements for active substances used as starting materials, derived from ICH Q7 (covered in our guide to Part 2);
- Annexes: the topic-specific annexes (sterile products, computerised systems, qualification and validation, reference samples...) that supplement the two parts for specific situations.
Part 1 is therefore the "horizontal" core of the guide: it applies to any medicinal product manufacturing site, whatever the dosage form, while the annexes add vertical requirements.
Why Part 1 matters in international audits
The strength of the PIC/S guide is not the content as such — which largely mirrors EU GMP — but its role as the common language of inspections. The 57 Participating Authorities (from the European agencies to the FDA, TGA, Health Canada and MHRA) use PE 009 as the reference for inspections and inspector training. In practice: if your site exports, the inspection bar you will face is Part 1. Knowing its structure lets you anticipate the inspector's questions, map your SOPs to the right chapters and answer with the correct reference instead of a generic "GMP rule".
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The 9 chapters of Part 1
Part 1 follows the operational life cycle of a site: from the quality system to people, from facilities to processes, up to self inspection. Here is the full map with the operational focus of each chapter:
| Chapter | Title | Operational focus |
|---|---|---|
| 1 | Pharmaceutical Quality System | PQS, Quality Risk Management, Product Quality Review, management responsibilities |
| 2 | Personnel | Key roles, training, personnel hygiene, job descriptions |
| 3 | Premises and Equipment | Layout, flows, cross-contamination prevention, equipment qualification |
| 4 | Documentation | Document hierarchy, good documentation practices, record retention |
| 5 | Production | Manufacturing operations, process validation, materials management, mix-up prevention |
| 6 | Quality Control | QC laboratory, sampling, specifications, on-going stability, OOS handling |
| 7 | Outsourced Activities | Outsourced operations, quality/technical agreements, contract giver responsibilities |
| 8 | Complaints, Quality Defects and Product Recalls | Complaints, quality defects, market recalls, root cause analysis |
| 9 | Self Inspection | Self-inspection programme, follow-up and corrective actions |
One practical consequence of this structure: many companies build the index of their Site Master File and their self-inspection plan around the 9 chapters, so every area of the site has a clear documentation "owner" and every inspection finding maps straight to a chapter.
PIC/S Part 1 vs EU GMP Part I: what actually changes
PIC/S Part 1 and Part I of EudraLex Volume 4 are substantially equivalent: same chapters, same numbering, same technical requirements. The differences are mostly formal, but worth knowing because they surface in inspections by non-EU Authorities:
- Legal references: the PIC/S version removes references to EU directives and regulations, replacing them with neutral wording applicable in any jurisdiction;
- Adoption timing: when the European Commission revises a chapter or annex, PIC/S adopts it through its own revision of PE 009, so there can be a time lag between the two texts (PE 009-18, for example, incorporated the Annex 19 on reference and retention samples published in EudraLex in June 2026);
- Annexes: the annexes are aligned too — the PIC/S Annex 1 on sterile medicinal products is identical to the EU one apart from very minor editorial differences, in force since 25 August 2023 (point 8.123 since 25 August 2024).
For EU-based operations the practical rule is simple: work on EudraLex Volume 4 and use PE 009 as the reference when your counterpart is a non-EU PIC/S Authority or an international business partner.
How to use Part 1 to prepare for an inspection
Three concrete uses that separate an "audit-ready" site from one that merely endures the inspection:
- Chapter-by-chapter gap assessment: a matrix crossing the 9 chapters with the site SOPs immediately highlights uncovered areas (typically Chapter 7 on outsourced activities and Chapter 8 on quality defect handling);
- Finding mapping: classifying internal and external audit findings by Part 1 chapter makes trends readable at management review;
- People preparation: whoever accompanies the inspector must be able to place every question in its reference chapter, to bring the right evidence first time.
GuideGxP recommendation
Do not study Part 1 as a text to read cover to cover: use it as a structural checklist. Start from Chapter 1 and check that your PQS formally covers QRM and PQR; then walk through Chapters 2-9 asking, for each one, which site SOP implements it and what evidence you would show an inspector tomorrow morning. Wherever the answer hesitates, you have found the gap to close before the next inspection. Also keep an eye on PE 009 revisions: every new version should be captured by the site's documentation change control.
To go beyond Part 1, our guide PIC/S in GMP – Operational Guide to the Scheme, the PI documents and the inspection covers the whole PIC/S ecosystem — scheme, GMP Guide and PI documents — with a ready-to-use audit toolkit.
