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. Changes in ...
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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. Changes in this new edition: Revised Annex 15. The revision of Annex 15 takes into account changes to other sections of the EudraLex, Volume 4, Part I, relationship to Part II, Annex 11, ICH Q8, Q9, Q10 and Q11, QWP guidance on process validation, and changes in manufacturing technology. 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. The introduction of guidelines on setting health based exposure limits for use in risk identification in the manufacture of different medicinal products in shared facilities. The introduction of guidelines on the formalised risk assessment for ascertaining the appropriate GMP for excipients. The addition of the Guidelines on principles of Good Distribution Practice of active substances for medicinal products for human use (2015/C 95/01). These guidelines provide stand-alone guidance on Good Distribution Practice (GDP) for manufacturers, importers and distributors of active substances for medicinal products for human use. These guidelines should be followed as of 21 September 2015. The addition of the principles and guidelines of Good Manufacturing Practice (GMP) for active substances for medicinal products for human use, including active substances intended for export. Revisions to the UK Human Medicines Regulations 2012. MHRA GMP Data Integrity Definitions and Guidance for Industry is now included which sets out MHRA expectations for data integrity in good manufacturing practice (GMP). The Guidance complements existing EU GMP guidance and should be read in conjunction with national medicines legislation and the GMP standards published in Eudralex volume.
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Good. Ships from UK in 48 hours or less (usually same day). Your purchase helps support Sri Lankan Children's Charity 'The Rainbow Centre'. Ex-library, so some stamps and wear, but in good overall condition. 100% money back guarantee. We are a world class secondhand bookstore based in Hertfordshire, United Kingdom and specialize in high quality textbooks across an enormous variety of subjects. We aim to provide a vast range of textbooks, rare and collectible books at a great price. Our donations to The Rainbow Centre have helped provide an education and a safe haven to hundreds of children who live in appalling conditions. We provide a 100% money back guarantee and are dedicated to providing our customers with the highest standards of service in the bookselling industry.
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Very good. Simply Brit – welcome to our online used book store, where affordability meets great quality. Dive into a world of captivating reads without breaking the bank. We take pride in offering a wide selection of used books, from classics to hidden gems, ensuring there's something for every literary palate. All orders are shipped within 24 hours and our lightning fast-delivery within 48 hours coupled with our prompt customer service ensures a smooth journey from ordering to delivery. Discover the joy of reading with us, your trusted source for affordable books that do not compromise on quality.
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Good. Simply Brit – welcome to our online used book store, where affordability meets great quality. Dive into a world of captivating reads without breaking the bank. We take pride in offering a wide selection of used books, from classics to hidden gems, ensuring there's something for every literary palate. All orders are shipped within 24 hours and our lightning fast-delivery within 48 hours coupled with our prompt customer service ensures a smooth journey from ordering to delivery. Discover the joy of reading with us, your trusted source for affordable books that do not compromise on quality.
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Good. **SHIPPED FROM UK** We believe you will be completely satisfied with our quick and reliable service. All orders are dispatched as swiftly as possible! Buy with confidence! Greener Books.
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This is an ex-library book and may have the usual library/used-book markings inside. This book has soft covers. In good all round condition. Please note the Image in this listing is a stock photo and may not match the covers of the actual item, 1350grams, ISBN: 9780857111029.
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Fine. Books In Good Condition. May Have a Small Publisher Mark. Ship Via Fedex. Shipping Time 7 To 10 Days. Bookseller With Over 20 Years In Book Trade.
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This is an ex-library book and may have the usual library/used-book markings inside. This book has soft covers. In good all round condition. Please note the Image in this listing is a stock photo and may not match the covers of the actual item, 1400grams, ISBN: 9780857111715.
