📗 Libro en inglés RULES AND GUIDANCE FOR PHARMACEUTICAL MANUFACTURERS AND DISTRIBUTORS (THE ORANGE GUIDE): 2015

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

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.

In addition, it contains new sections on:

- 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.

The Orange Guide is compiled by the Inspection, Enforcement and Standards Division, MHRA, London, UK.