Rules and Guidance for Pharmaceutical Manufacturers and Distributors

This is the eighth edition of Rules and Guidance for Pharmaceutical Manufacturers and Distributors, compiled by the 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.

Since the 2007 edition there have been significant changes and additions to the detailed European Community guidelines on Good Manufacturing Practice (GMP), as well as substantial amendments to the Community code relating to medicinal products for human use.

This new edition covers these important changes as well as featuring:

Changes to the EU Guide on GMP, including the addition of Part III
Revised EU Guide for good distribution practice
Revisions to the EU Directive on medicines for human use
New chapters for brokers of finished medicines and manufacturers, importers and distributors of active substances as a result of Falsified Medicines Directive 2011/62/EU
Updated chapters on the work of the MHRA
Extracts from the UK's consolidated human medicines legislation
New appendix of names and addresses of other EU medicines regulators.


With restructured contents and index and a fresh design, the new edition of The Orange Guide offers easy navigation of these important changes.

1. MHRA: Licensing, Inspection and Enforcement for Human Medicines

2. EU Guidance on Good Manufacturing Practice

Part I: Basic Requirements for Medicinal Products
1. Pharmaceutical Quality System
2. Personnel
3. Premises and Equipment
4. Documentation
5. Production
6. Quality Control
7. Outsourced Activities
8. Complaints and Product Recall
9. Self Inspection
Annex 1. Manufacture of Sterile Medicinal Products
Annex 2. Manufacture of Biological Active Substances and Medicinal Products for Human Use
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. Investigational Medicinal Products
Annex 14. Manufacture of Medicinal Products Derived from Human Blood or Plasma
Annex 15. Qualification and Validation
Annex 16. Certification by a Qualified Person and Batch Release
Annex 17. Parametric Release
Annex 18. Good Manufacturing Practice for Active Pharmaceutical Ingredients
Annex 19. Reference and Retention Samples
Annex 20. Quality Risk Management
Glossary of Terms Used in the EU Guide to GMP

Part II: Basic Requirements for Active Substances Used as Starting Materials

Part III: GMP Related Documents
Site Master File – Explanatory Notes on the Preparation of a Site Master File
Annex Content of Site Master File
Quality Risk Management (ICH Q9)
Annex I. Risk Management Methods and Tools
Annex II. Potential Applications for Quality Risk Management
ICH Q10 Note for Guidance on Pharmaceutical Quality System (ICH Q10)
Annex 1. Potential Opportunities to Enhance Science and Risk Based Regulatory Approaches
Annex 2. MRA Batch Certificate
Template for the ‘Written Confirmation’ for Active Substances Exported to the European Union for Medicinal Products for Human Use, in Accordance with Article 46B(2)(b) of Directive 2001/83/EC

3. UK Guidance on Manufacture

4. UK Guidance on the Manufacture, Importation and Distribution of Active Substances

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

8. Guidelines on Good Distribution Practice of Medicinal Products for Human Use (2013/C 68/01)

9. UK Guidance on Wholesale Distribution Practice

10. UK Guidance on Brokering Medicines

11. EU Legislation on Wholesale Distribution and Brokering Medicines

12. UK Legislation on Wholesale Distribution

13. UK Legislation on Brokering Medicines

Glossary of Legislation

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