Chapter 1
Chapter 1 - Pharmaceutical Quality System
EudraLex Volume 4 Part I Chapter 1 guidance on the Pharmaceutical Quality System for medicinal products.
Key Documents
EudraLex Volume 4
Structured access across Part I, Part II, Part III, Annexes, Part IV, and related GMP/GDP documents.
Part I - Basic Requirements for Medicinal Products
Chapter-by-chapter access in true numeric order.
Chapter 2
Chapter 2 - Personnel
EudraLex Volume 4 Part I Chapter 2 guidance on personnel responsibilities, training, and hygiene.
Chapter 3
Chapter 3 - Premises and Equipment
EudraLex Volume 4 Part I Chapter 3 guidance on premises, equipment, and facility controls.
Chapter 4
Chapter 4 - Documentation
EudraLex Volume 4 Part I Chapter 4 guidance on GMP documentation and good documentation practice.
Chapter 5
Chapter 5 - Production
EudraLex Volume 4 Part I Chapter 5 guidance on production and manufacturing controls.
Chapter 6
Chapter 6 - Quality Control
EudraLex Volume 4 Part I Chapter 6 guidance on Quality Control requirements and responsibilities.
Chapter 7
Chapter 7 - Outsourced Activities
EudraLex Volume 4 Part I Chapter 7 guidance on outsourced activities and contract arrangements.
Chapter 8
Chapter 8 - Complaints and Product Recall
EudraLex Volume 4 Part I Chapter 8 guidance on complaints handling and product recall systems.
Chapter 9
Chapter 9 - Self Inspection
EudraLex Volume 4 Part I Chapter 9 guidance on self inspection and internal audit expectations.
Part II - Basic Requirements for Active Substances used as Starting Materials
Core Part II requirements documents.
Basic requirements for active substances used as starting materials
EudraLex Volume 4 Part II guidance covering GMP requirements for active substances used as starting materials.
Part III - GMP related documents
Supporting GMP guidance and templates related to Volume 4.
Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
Part III GMP related scientific guideline for health-based exposure limits in shared facilities.
Guideline on the responsibilities of the sponsor with regard to handling and shipping of investigational medicinal products for human use in accordance with Good Clinical Practice and Good Manufacturing Practice
Part III GMP related guideline for handling and shipping investigational medicinal products.
Guidelines of 19 March 2015 on the formalised risk assessment for ascertaining the appropriate good manufacturing practice for excipients of medicinal products for human use
Part III GMP related guideline on risk assessment for excipients in medicinal products.
MRA Batch Certificate
Part III GMP related document providing the Mutual Recognition Agreement batch certificate format.
Q10 Note for Guidance on Pharmaceutical Quality System
Part III GMP related document for ICH Q10 pharmaceutical quality system expectations.
Q9 Quality Risk Management
Part III GMP related document for ICH Q9 quality risk management principles.
Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders
Part III GMP related guidance on marketing authorisation holder and responsible person GMP responsibilities.
Site Master File
Part III GMP related document describing the Site Master File structure and expectations.
Template for IMP batch release
Part III GMP related template for investigational medicinal product batch certification.
Template for the "written confirmation" for active substances exported to the European Union for medicinal products for human use
Part III GMP related template used for written confirmation and related GMP declarations.
Annexes
Annex documents in true numeric order.
Annex 1
Annex 1 - Manufacture of Sterile Medicinal Products
Annex 1 guidance for manufacture of sterile medicinal products and contamination control strategy.
Annex 2
Annex 2 - Manufacture of Biological active substances and Medicinal Products for Human Use
Annex 2 guidance for biological active substances and medicinal products.
Annex 3
Annex 3 - Manufacture of Radiopharmaceuticals
Annex 3 guidance for manufacture of radiopharmaceuticals.
Annex 4
Annex 4 - Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products
Annex 4 guidance for manufacture of veterinary medicinal products.
Annex 5
Annex 5 - Manufacture of Immunological Veterinary Medicinal Products
Annex 5 guidance for manufacture of immunological veterinary medicinal products.
Annex 6
Annex 6 - Manufacture of Medicinal Gases
Annex 6 guidance for manufacture of medicinal gases.
Annex 7
Annex 7 - Manufacture of Herbal Medicinal Products
Annex 7 guidance for manufacture of herbal medicinal products.
Annex 8
Annex 8 - Sampling of Starting and Packaging Materials
Annex 8 guidance for sampling of starting and packaging materials.
Annex 9
Annex 9 - Manufacture of Liquids, Creams and Ointments
Annex 9 guidance for manufacture of liquids, creams and ointments.
Annex 10
Annex 10 - Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation
Annex 10 guidance for pressurised metered dose aerosol preparations.
Annex 11
Annex 11 - Computerised Systems
Annex 11 guidance for GMP-compliant computerised systems.
Annex 12
Annex 12 - Use of Ionising Radiation in the Manufacture of Medicinal Products
Annex 12 guidance for use of ionising radiation in medicinal product manufacture.
Annex 13
Annex 13 - Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014
Annex 13 guidance for investigational medicinal products.
Annex 14
Annex 14 - Manufacture of Products derived from Human Blood or Human Plasma
Annex 14 guidance for medicinal products derived from human blood or plasma.
Annex 15
Annex 15 - Qualification and validation
Annex 15 guidance for qualification and validation activities.
Annex 16
Annex 16 - Certification by a Qualified Person and Batch Release
Annex 16 guidance for qualified person certification and batch release.
Annex 17
Annex 17 - Real Time Release Testing and Parametric release
Annex 17 guidance for real time release testing and parametric release.
Annex 19
Annex 19 - Reference and Retention Samples
Annex 19 guidance for reference and retention sample management.
Annex 21
Annex 21 - Importation of medicinal products
Annex 21 guidance for importation of medicinal products into the Union.
Part IV - GMP requirements for Advanced Therapy Medicinal Products
Part IV guidance for ATMP-focused GMP requirements.
Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
EudraLex Volume 4 Part IV GMP requirements for advanced therapy medicinal products.
Other documents related to GMP and GDP
Related GMP/GDP references and regulatory documents.
Compilation of Union Procedures on Inspections and Exchange of Information
Compilation of Union procedures related to inspections, interpretation documents and templates.
Guidance on good manufacturing practice and good distribution practice: Questions and answers
EMA questions and answers on good manufacturing practice and good distribution practice requirements.
Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use
Guidelines for formalised risk assessment to determine GMP for excipients (2015/C 95/01).
Guidelines on Good Distribution Practice of Medicinal Products for Human Use
Guidelines on good distribution practice of medicinal products for human use (2013/C 343/01).
Regulation (EU) 2021/1248
EUR-Lex text for Regulation (EU) 2021/1248 relevant to GMP and GDP context.
Regulation (EU) 2021/1280
EUR-Lex text for Regulation (EU) 2021/1280 relevant to GMP and GDP context.
