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Utilising cost reduction opportunities: Conference on "Optimising Stability Testing" in London
International experts discussed how to realise more efficient stability tests for medicinal products last Thursday and Friday (18 and 19 September) in London.
"Laboratory analysis is a cost factor that still offers room for manoeuvre in many companies" reported Dr Sven Oliver Kruse. The flexibility in the EU GMP guideline on "Ongoing stability" in particular offers opportunities for improved efficiency. For example, for generally identical medicinal products with a similar primary packaging but different strengths the guideline permits group building within the concept of "bracketing"
At the "Optimising Stability Testing" conference a total of 14 speakers described a variety of options for optimising stability testing – from the form of the study design, through analytical and statistical evaluation procedures, data and report management systems up to outsourcing. Pharmaceutical industry chief executives and senior staff from Europe, North America and Africa, from company laboratories and from service providers attended the conference in London initiated by Visiongain.
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