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Useful Info
Below are a selection of useful links, including: EU legislation, Changes to EudraLex Volume 4 since publication of the 2007 'Orange Guide', Pending revisions to EudraLex Volume 4, plus various documents and websites of interest.
Useful EU Legislation
- Directive 2001/83/EC (The 'Medicinal Products for Human Use' directive), as ammended by:
- Directive 2002/98/EC (human blood and blood components)
- Directive 2003/63/EC
- Directive 2004/24/EC (traditional herbal products)
- Directive 2004/27/EC
- Directive 2008/29/EC
- Regulation 1394/2007 (The 'Advanced Therapy Medicinal Products' regulation)
- Directive 2009/53/EC (Variations for marketed products)
- Directive 2009/120/EC (Advanced Therapy Medicinal Products)
- Directive 2010/84/EC (Pharmacovigilance)
- Directive 2011/62/EU (Falsification of Medicines)
- Directive 2001/20/EC (The ‘Clinical Trials Directive’)
- Directive 2003/94/EC (The ‘GMP Directive’)
- Directive 2004/23/EC (The 'Tissues and Cells' Directive)
- Directive 2005/28/EC (The ‘GCP Directive’)
- Guideline 94/C 63/03 (Good Distribution Practice)
Changes to EudraLex Volume 4 (EU GMPs) since publication of the 2007 'Orange Guide'
- Chapter 1 - Quality Management (Feb 2008)
- Chapter 4 - Documentation (effective 30 Jun 2011)
- Annex 1 - Manufacture of Sterile Medicinal Products (Feb 2008)
- Annex 3- Manufacture of Radiopharmaceuticals (Sep 2008)
- Annex 6 - Manufacture of Medicinal Gases (Feb 2010)
- Annex 7- Manufacture of Herbal Medicinal Products (Sep 2008)
- Annex 11 - Computerised Systems (effective 30 Jun 2011)
- Annex 13 - Manufacture of Investigational Medicinal Products (Feb 2010)
- NEW Annex 20 - Quality Risk Management (Feb 2008)
- Part II - Basic Requirements for Active Substances used as Starting Materials (Feb 2010)
Pending Revisions to EudraLex Volume 4 (previously issued for public consultation)
- Chapter 1 - Quality Management System
- Chapter 2 - Personnel
- Chapter 3 & Chapter 5: Update on revision of Chapters 3 and 5, regarding "dedicated facilities"
- Chapter 7 - Contract Manufacture and Analysis
- Annex 2 - Manufacture of Biological Medicinal Products for Human Use
- Annex 14 - Manufacture of Medicinal Products Derived from Human Blood or Plasma
- Part III - Site Master File
Useful Info
- EMEA Guideline: Declaration of Storage Conditions (CPMP/QWP/609/96/Rev 2)
- EU Q&A: Good Manufacturing Practice (GMP) (click here)
- FDA 'Questions and Answers on Current Good Manufacturing Practices (cGMP) for Drugs' (click here)
- **Update to "QP Discretion" Paper** officially entitled: 'EMEA Reflection Paper on a proposed solution for dealing with minor deviations from the details described in the Marketing Authorisation for human and veterinary medicinal products (Rev. 1)', EMEA/INS/GMP/227075/2008 (06 Jan 2009) NB: Includes IMPs (despite title!), previous version EMEA/INS/GMP/71188/2006 is no longer available on EMA website
- QP Code of Practice (click here)
- Mutual Recognition Agreements (MRAs)
- EMEA Reflection Paper: Water for Injection Prepared by Reverse Osmosis (EMEA/CHMP/CVMP/QWP/28271/2008)
- EMEA Guideline: Human Cell-Based Medicinal Products (EMEA/CHMP/410869/2006) (May 2008)
- EMEA Guideline: Virus Safety Evaluation of Biotechnological Investigational Medicinal Products (EMEA/CHMP/BWP/398498/2005) (Jul 2008)
- EMEA Guideline: Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials (CHMP/QWP/185401/2004 final) (Mar 2006)
- FDA Guidance for Industry: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production (click here) (Oct 2006)
- FDA Guidance for Industry: CGMP for Phase 1 Investigational Drugs (click here) (Jul 2008)
- Active Pharmaceutical Ingredients Committee (APIC) Quick Guide for API Sourcing (click here) (Sep 2008)
- EMEA Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies and Related Products EMEA/CHMP/BWP/157653/2007 (Dec 2008)
- The 2008 revision to the Declaration of Helsinki
- 2004/C 24/03 Note for guidance on minimising the risk of transmitting animal spongiform encephalopathyagents via human and veterinary medicinal products (EMEA/410/01 Rev. 2 ó October 2003)