Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 - The Orange Guide

Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2015 - The Orange Guide

Author: MHRA (Medicines and Healthcare products Regulatory Agency)

Publisher: Pharmaceutical Press

Published: 2015

Hardback, 1 volume

Pages: 672 pp.

Product Dimensions: 244 x 172mm

ISBN: 978 0 85711 171 5

This is the ninth 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 2015 edition incorporates all the significant updates and additions to the detailed European Community guidelines on GMP since the last edition, including the revised EU Guidelines on Good Distribution Practice.

The Book include: In addition, it contains new sections

§  The Gold Standard for Responsible Persons

§  MHRA Innovation Office

§  The Application and Inspection process for new licences – "what to expect”

§  MHRA Compliance Management and Inspection Action Group

§  MHRA Risk-based inspection programme

§  Naming Contract Quality Control (QC) laboratories

§  GDP Quality Systems

§  A new flow chart on registration requirements for UK companies involved in the sourcing and supply of active substances (ASs), to be used in the manufacture of licensed human medicines

Building on the restructured contents and fresh redesign of the last edition, you’ll find all the answers you need to stay informed.

Contents:

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, Quality Defects and Product Recalls

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 Ionizing 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

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

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 343/01)

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

Appendix

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