The Orange Guide Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017

The Orange Guide Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017

The Orange Guide
MHRA (Medicines and Healthcare products Regulatory Agency)
2017

Compiled by the Inspection, Enforcement and Standards Division, Medicines and Healthcare products Regulatory Agency (MHRA), London, UK

This is the tenth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by MHRA. Commonly known as the Orange Guide, it remains an essential reference for all manufacturers and distributors of medicines in Europe. It provides a single authoritative source of European and UK guidance, information and legislation relating to the manufacture and distribution of human medicines.

The new 2017 edition has been updated to incorporate changes and additions made to the detailed European Community guidelines on Good Manufacturing Practice (GMP) and the revised EU Guidelines on Good Distribution Practice (GDP), including Annexes 15 and 16.

Comprehensive new content includes:
• qualification of suppliers and customers
• parallel importation and parallel distribution
• temperature control and monitoring
• UK legislation
• unlicensed medicines

There are new MHRA sections on:
• GMP for excipients
• guidance on revised Annex 16 of GMP
• data Integrity definitions and guidance for industry

Plus new Commission guidance on:
• principles and guidelines of GMP for active substances
• principles of GDP of active substances
• setting health based exposure limits
• formalised risk assessment for ascertaining the appropriate GMP for excipients.

The work includes EU regulation on safety features for medicines, along with two Commission Q&As on the importation of active substances and safety features for medicinal products.

A new appendix on sources of useful information has also been added.

The Orange Guide is essential reading for anyone subject to MHRA inspection, providing you with all the answers you need to stay informed.

It is compiled by the Inspection, Enforcement and Standards Division, MHRA, London, UK [www.gov.uk/mhra].

TABLE OF CONTENTS :

MHRA
1. MHRA: Licensing, Inspection and Enforcement for Human Medicines
Guidance on Good Manufacturing Practice (GMP)
2. EU Guidance on Good Manufacturing Practice
Guidance on Manufacture and Importation
3. UK Guidance on Manufacture
4. UK Guidance on the Manufacture, Importation and Distribution of Active Substances
Legislation on Manufacture and Importation
5. EU Legislation on Manufacture and Importation
6. UK Legislation on Manufacture and Importation
7. UK Legislation on the Manufacture, Importation and Distribution of Active Substances
Guidance on Good Distribution Practice for Wholesaling, Brokering and Active Substances
8. Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 343/01)
9. Guidelines of 19 March 2015 on Principles of Good Distribution Practice of Active Substances for Medicinal Products for Human Use (2015/C 95/01)
10. UK Guidance on Wholesale Distribution Practice
11. UK Guidance on Brokering Medicines
Legislation on Wholesale Distribution and Brokering Medicines
12. EU Legislation on Wholesale Distribution and Brokering Medicines
13. UK Legislation on Wholesale Distribution
14. UK Legislation on Brokering Medicines
Appendices
Appendix 1 – Human and Veterinary Medicines Authorities in Europe
Appendix 2 – Sources of Useful Information
Appendix 3 – Importation of Active Substances for Medicinal Products for Human Use
Appendix 4 – Safety Features for Medicinal Products for Human Use – Questions and Answers
Index