Rules and Guidance for Pharmaceutical Manufacturers and Distributors 8th Edition by MHRA ISBN 0857111027 9780857111029

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Product details:

ISBN 10: 0857111027 

ISBN 13: 9780857111029

Author: MHRA  

Familiarly known as the “Orange Guide,” this title is an essential reference work for all those involved in the manufacture or distribution of medicines in or for Europe. It is compiled by the UK drug regulatory body, the MHRA, and brings together the European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. It therefore contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation.

Table of contents:

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

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Tags: MHRA, Rules, Guidance, Pharmaceutical, Manufacturers, Distributors