The European Medicines Agency

Regulation (EC) 726/2004

Directive 2001/83/EC

Directive 2003/94/EC - The principles and guidelines for GMP

Coordination of GMP Inspections in Europe

SOP for GMP Inspections in Europe

Compliation of Community Procedures on Inspections and Exchange of Information

EU Draft Guideline: Testing During Unannounced Audits, Medical Devices

European Commission – Eudralex GMP Regulation


Part I - Basic Requirements for Medicinal Products

Chapter 1 - Pharmaceutical Quality System

Chapter 1 - Quality Management

Chapter 2 - Personnel

Chapter 3 - Premise and Equipment

Chapter 4 - Documentation

Chapter 5 - Production

Chapter 6 - Quality Control

Chapter 7 - Section on Outsourced Activities

Chapter 7 - Contract Manufacture and Analysis

Chapter 8 - Complaints and Product Recall

Chapter 9 - Self Inspection

Part II - Basic Requirements for Active Substances used as Starting Materials

Basic requirements for active substances used as starting materials

Part III - GMP related documents

Site Master File

Q9 Quality Risk Management

Q10 Note for Guidance on Pharmaceutical Quality System

MRA Batch Certificate

Template for the 'written confirmation' for active substances exported to the European Union for medicinal products for human use


Annex 1 - Manufacture of Sterile Medicinal Products

Annex 2 - Manufacture of Biological active substances and Medicinal Products for Human Use

Annex 2 - Manufacture of Biological Medicinal Products for Human Use

Annex 3 - Manufacture of Radiopharmaceuticals

Annex 4 - Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products

Annex 5 - Manufacture of Immunological Veterinary Medicinal Products

Annex 6 - Manufacture of Medicinal Gases

Annex 7 - Manufacture of Herbal Medicinal Products

Annex 8- Sampling of Starting and Packaging Materials

Annex 9 - Manufacture of Liquids, Creams and Ointments

Annex 10 - Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation

Annex 11 - Computerised Systems

Annex 12 - Use of Ionising Radiation in the Manufacture of Medicinal Products

Annex 13 - Manufacture of Investigational Medicinal Products

Annex 14 - Manufacture of Products derived from Human Blood or Human Plasma

Annex 15 - Qualification and validation

Annex 16 - Certification by a Qualified person and Batch Release

Annex 17 - Parametric Release

Annex 19 - Reference and Retention Samples



The Pharmaceutical Inspection Co-operation Scheme

Guide to Good Distribution Practice (GDP) for Medicinal Products

GMP Guide for Blood Establishments

Guidance on Parametric Release

Validation Master Plan Installation and Operational Qualification Non-Sterile Process Validation Cleaning Validation

Validation of Aseptic Processes

Guide to Inspections of Source Plasma Establishments Aand Plasma Warehouses (Inspection Guide)

Good Practices for Computerised Systems in Regulated GxP Environments

Guide to Good Practices for The Preparation of Medicinal Products in Healthcare Establishments (PE 010-4)

Recommendation on Sterility Testing

Isolators used for Aseptic Processing and Sterility Testing

Technical Interpretation of Revised Annex 1 to PIC/S GMP Guide

Recommendation on Risk-Based Inspection Planning