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Leachables and Extractables have been considered by the pharmaceutical industry for a number of years, illustrated by the FDA requiring NDAs and ANDAs to demonstrate that they had been considered in relation to closure systems. However, up until recently, a majority of the testing and research on this subject focused on Orally Inhaled and Nasal Drug Products (OINDP) as these have the highest risk of leachables and extractables. It is only now that the significance of them on all drug products is being realised and this conference will consider the impact of drug impurities from manufacturing and packaging on all drug products and medical devices.
With ever-evolving best practice and guidelines on leachables & extractables, this conference was a one-stop source of current information on the topic. With two presentations from regulatory authorities, the current regulatory climate will be investigated, and then the impact of this on both the supplier and pharmaceutical perspective explored through expert delivered papers. Other sessions on leachables and extractables in OINDP, Parenteral and Opthlamic Drug Products (PODP), medical devices, dermal membrane, leachables and extractables testing, case studies and polymer producers perspective.
All technical papers presented at the Leachables and Extractables Conference in Barcelona, Spain on 13-14 May 2009 are included in the Proceedings.
For more information visit http://www.researchandmarkets.com/research/34562f/leachables_and_ext
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