EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines
Update 05.09.2018
Volume 4 of "The rules governing medicinal products in the European Union" contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.
Introduction
- Introduction (07/02/2011)
- Commission Directive 2003/94/EC, of 8 October 2003, laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use.
Replacement of Commission Directive 91/356/EC of 13 June 1991 to cover good manufacturing practice of investigational medicinal products.
- Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice for veterinary medicinal products.
- Commission Delegated Regulation (EU) 2017/1569 (for linguistic versions, click here) of 23 May 2017 supplementing Regulation (EU) 536/2014 of the European Parliament and of the Council by specifying principles and guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
- Commission Directive (EU) 2017/1572 (for linguistic versions, click here) of 15 September 2017 supplementing Directive 2001/83/EC of the European Parliament and of the Council as regards the principles and guidelines of good manufacturing practice for medicinal products for human use (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
Part I - Basic Requirements for Medicinal Products
- Chapter 1 - Pharmaceutical Quality System (into operation since 31 January 2013)
- Chapter 2 - Personnel (into operation since 16 February 2014)
- Chapter 3 - Premise and Equipment (into operation since 1 March 2015)
- - See transitional arrangement for toxicological evaluation on page 1 of Chapter 3
- - Previous version
Chapter 4 - Documentation
Chapter 5 - Production (into operation since 1 March 2015)
- - See transitional arrangement for toxicological evaluation on pages 1-2 of Chapter 5
- - Previous version
- Chapter 6 - Quality Control (into operation since 1 October 2014)
- Chapter 7 - Outsourced activities
- Chapter 8 - Complaints and Product Recall (into operation since 1 March 2015)
- Chapter 9 - Self Inspection
Part II - Basic Requirements for Active Substances used as Starting Materials
- Basic requirements for active substances used as starting materials (August 2014)
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 (Version 2, January 2013)
- Guideline on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities
- 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 (all language versions are available here). A risk assessment as set out in these guidelines should be carried out for excipients for authorised medicinal products for human use by 21 March 2016.
- Template for IMP batch release (applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)
Annexes
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Annex 1 |
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Annex 2 |
New - Manufacture of Biological active substances and Medicinal Products for Human Use(into operation since 26 June 2018)
Annex 2 is no longer applicable to Advanced Therapy Medicinal Products to which applies the Commission guideline on Good |
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Annex 3 |
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Annex 4 |
Manufacture of Veterinary Medicinal Products other than Immunological Veterinary Medicinal Products |
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Annex 5 |
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Annex 6 |
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Annex 7 |
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Annex 8 |
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Annex 9 |
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Annex 10 |
Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation |
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Annex 11 |
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Annex 12 |
Use of Ionising Radiation in the Manufacture of Medicinal Products |
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Annex 13 |
Manufacture of Investigational Medicinal Products
Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal Article 63(1) of Regulation (EU) No 536/2014 |
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Annex 14 |
Manufacture of Products derived from Human Blood or Human Plasma |
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Annex 15 |
Qualification and validation (into operation since 1 October 2015) |
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Annex 16 |
Certification by a Qualified Person and Batch Release (into operation since 15 April 2016) |
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Annex 17 |
New - Parametric release (Deadline for coming into operation: 26 December 2018) |
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Annex 19 |
Glossary
- Glossary
Part IV - GMP requirements for Advanced Therapy Medicinal Products
- Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products
Other documents related to GMP
- A revised version of the "Guidelines on Good Distribution Practice of Medicinal Products for Human Use" was published in the Official Journal and is applicable as of 24 November 2013 (OJ C 343/1, 23.11.2013).
- Guidelines of 19 March 2015 on principles of Good Distribution Practice of active substances for medicinal products for human use(all language versions are available here). These guidelines will come into operation on 21 September 2015.
https://ec.europa.eu/health/documents/eudralex/vol-4_it
The EU legal framework for medicinal products guarantees high standards of quality and safety. It also promotes the functioning of the internal market, with measures that encourage innovation and competiveness in Europe. It is based on the principle that medicinal products may be placed on the market only following a marketing authorisation granted by the competent authorities. A large body of legislation has developed around this principle with the progressive harmonisation of requirements implemented across the whole European Economic Area.
Today, medicinal products are authorised at EU level by the European Commission or at national level by the competent authorities of EU countries. Special rules exist for the authorisation of medicinal products for paediatric use, orphan medicines, traditional herbal medicines, vaccines and clinical trials. Once placed on the market, the safety of a medicinal product continues to be monitored throughout its entire lifespan through the EU system of pharmacovigilance
The European Medicines Agency, established in 1995, underpins the centralised authorisation procedure and supports coordination between national competent authorities. The Agency is the hub of a European medicines network comprising over 40 national regulatory authorities guaranteeing a constant exchange and flow of information regarding the scientific assessment of medicinal products in the EU.
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