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EU GMP guide

The EU Guidelines for Good Manufacturing Practice for medicinal products (EudraLex Volume 4), split into paragraphs you can read and link to one by one.

35 documents Checked against the Commission's index on 27 Oct 2026 Official EudraLex Volume 4 page

Independent edition, not an official version. Source: European Commission, EudraLex Volume 4, © European Union, reused under CC BY 4.0 (Commission Decision 2011/833/EU). Compliome extracts the text from the official PDFs and splits it into paragraphs; the European Commission does not endorse Compliome. Not legal advice.

Introduction

Introduction 2 ¶

Part I

Chapter 1 Pharmaceutical Quality System 15 ¶
Chapter 2 Personnel 25 ¶
Chapter 3 Premise and Equipment 46 ¶
Chapter 4 Documentation 39 ¶
Chapter 5 Production 73 ¶
Chapter 6 Quality Control 43 ¶
Chapter 7 Outsourced activities 19 ¶
Chapter 8 Complaints and Product Recall 33 ¶
Chapter 9 Self Inspection 4 ¶

Part II

Part II Basic requirements for active substances used as starting materials 407 ¶

Part III

Part IV

Part IV Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products 543 ¶

Annexes

Glossary

Glossary 51 ¶