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| Available: 0 |
| List Price:$118.00 |
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| Edition: | 1st |
| Publisher: | Pharmaceutical Press |
| ISBN: | 0-85711-285-6 (0857112856) |
| ISBN-13: | 978-0-85711-285-9 (9780857112859) |
| Old Edition: | 0-85711-171-X |
| Format: | British |
| Binding: | Softcover |
| Copyright: | 2017 |
| Publish Date: | 01/17 |
| Volume: | 2017 |
| Weight: | 3.56 Lbs. |
| Pages: | 806 |
| Subject Class: | PHM (Pharmacy and Pharmaceutical Industry) |
| Return Policy: | Returns accepted up to 12 months provided no other recalls or return restrictions apply. |
| ProQuest Ebook Central: |
Available in ProQuest Ebook Central™ View
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| Discipline: | Pharmacology | | Subject Definition: | Legislation, Drug-Europe-Great Britain-Guideline | | NLM Class: | QV 33 | | LC Class: | RS192 | | Abstract: | Familiarly known as the Orange Guide, this title is an essential reference work for all those involved in the manufacture and distribution of medicines in Europe. It is compiled by the UK drug regulatory body, 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 contains EU guidance on good manufacturing and good distribution practice along with relevant information on EU and UK legislation. ... Revised Annex 16. The GMP Guide Annex 16 has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable. Also, some areas, where the interpretation by Member States has not been consistent, have been clarified. This revised Annex came into operation 15 April 2016. |
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