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Leachables and Extractables for Pharmaceutical Products

Leachables and Extractables for Pharmaceutical Products by Pira International Ltd
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Impurities originating from any part of the manufacturing or storage of drug products can potentially result in expensive product recalls and damage to a company's reputation - not to mention the serious threat posed to patient safety. Nowadays extractables and leachables assessment of all materials - and especially elastomeric and plastic components - forms an integral part of the submission for approval of a new drug system or medical device. With regulatory authorities such as the FDA and the MHRA demanding assurance that a product's integrity has been scrutinised - the pharmaceutical industry has formed a range of industry working groups such as the Product Quality Research Institute (PQRI), Parenteral and Ophthalmic Drug Products (PODP), Extractables and Leachables Safety Information Exchange (ELSIE) and Bio-Process Systems Alliance (BPSA) to work towards a common understanding of what extractables and leachables testing should be done and at what stage in the supply chain it is most appropriate. These proceedings cover all the presentations from the conference which provided a unique opportunity to learn about the latest developments from industry practitioners and working groups to meet regulatory requirements and ensure compatibility in drug-package combinations.
iSmithers Rapra Publishing; November 2010
198 pages; ISBN 9781847358813
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Title: Leachables and Extractables for Pharmaceutical Products
Author: Pira International Ltd