Rules and Guidance for Pharmaceutical Manufacturers and Distributors
"The Orange Guide"
MHRA (Medicines and Healthcare products Regulatory Agency)
Compiled by the Inspection and Standards Division, MHRA (Medicines and Healthcare products Regulatory Agency), London, UK
The Orange Guide collates in one convenient and authoritative source European and UK guidance documents and information on legislation relating to the manufacture and distribution of medicines for human use. Compliance with Good Manufacturing Practice and Good Distribution Practice requirements is essential in the production and distribution of medicines for human use to safeguard public health and comply with legislation.
Changes to this edition include:
- Detailed changes to the EU guide to good manufacturing practice
- Detailed revisions to the EU Directive on medicinal products for human use
- The new Directive on the Principles and Guidelines on Good Manufacturing Practice of Medicinal Products for Human Use
- Restructured contents and clearer text design
- A subject index.
Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2007 is also available as an eBook.
Section 1: Medicines and Healthcare products Regulatory Agency (MHRA)
1. MHRA: Licensing, inspection and enforcement for human medicines
Section 2: Guidance on Good Manufacturing Practice (GMP)
2. EU guidance on good manufacturing practice
Part 1: Basic requirements for medicinal products
1. Quality management
3. Premises and equipment
6. Quality control
7. Contract manufacture and analysis
8. Complaints and product recall
9. Self inspection
Part 2: Basic requirements for active substances used as starting materials
3. UK guidance on manufacture
Section 3: Legislation on Manufacture
4. EU legislation on manufacture
5. UK legislation on manufacture
Section 4: Guidance on wholesale distribution practice
6. EU guidance on wholesale distribution practice
7. UK guidance on wholesale distribution practice
Section 5: Legislation on Wholesale Distribution
8. EU legislation on wholesale distribution
9. UK legislation on wholesale distribution
Section 6: Glossary of Legislation
Section 7: Index
'The Orange Guide has been a convenient and authoritative source of information since 1971. The 2007 edition continues in that great tradition. What I really like about the publication is the availability of a significant number of useful and relevant guidance documents in one place...very amenable to being carted around in your briefcase...no excuse not to have within easy reach and for it to be well thumbed.'
Ann McGee, The Irish Pharmacy Journal, 2007, 85 (4), 172
'...one major advantage of this book is its efficient use as one complete, integrated volume. Another beneficial feature is the availability of the book as a CD-ROM. All of the latest revisions to the regulations are found in one place. It is very straightforward as a reference work...as a reproduction of official rule and regulations that every manufacturer needs, this is a must-have item for any endeavour doing business within the EU or planning to do so in the future.'
Doody Enterprises, Albert I Wertheimer, Temple University School of Pharmacy, Philadelphia, USA
ISBN 978 0 85369 719 0
Published Feb 2007
244 x 172mm (448pp)
Other formats available
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