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EudraLex - Volume 4 - Good Manufacturing Practice (GMP) guidelines

ID 4460 | | Visite: 40716 | MedicinalPermalink: https://www.certifico.com/id/4460

Temi: Medicinal

Guidelines of good manufacturing practices for medicinal

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

Annex 1

Manufacture of Sterile Medicinal Products

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
Manufacturing Practice for Advanced Therapy Medicinal Products, published in Part IV of Eudralex Volume 4 and operational as of 22 May 2018.

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

Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal Article 63(1) of Regulation (EU) No 536/2014   
(applicable as from the date of entry into application of Regulation (EU) No 536/2014 on Clinical Trials)

Annex 14

Manufacture of Products derived from Human Blood or Human Plasma

Annex 15

Qualification and validation (into operation since 1 October 2015)

Annex 16

Certification by a Qualified Person and Batch Release (into operation since 15 April 2016)

Annex 17

New - Parametric release (Deadline for coming into operation: 26 December 2018)
Further information on the consultation can be found here.

Annex 19

Reference and Retention Samples

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

Compilation of Community Procedures on Inspections and Exchange of Information updated to include new EU formats and procedures

- 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

Medicinal products

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.

Legal framework governing medicinal products for human use in the EU
Legal framework

Medicines for children
Medicines for children

Orphan medicines
Orphan medicines

Advanced therapies
Advanced therapies

Pharmaceutical committee
Pharmaceutical committee
and expert groups

Clinical trials
Clinical trials

Falsified medicines
Falsified medicines

EU logo
EU Logo for
online sale of medicines

Good Manufacturing and Distribution Practices
Good Manufacturing and
Distribution Practices

Pharmacovigilance
Pharmacovigilance

Traditional herbal medicines
Traditional herbal
medicines

Personalised medicine
Personalised medicine

Medicines and the environment
Medicines and
the environment

Call
Call for EMA committees
and board members

Call
Veterinary medicinal products

Tags: Medicinal

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