As pharmaceutical product recalls continue to make headlines, Pharmig’s annual event in Oxford, UK, in November 2013 focused on a more proactive approach to preventing microbial contamination. The event drew speakers from around the world, with expertise from the regulatory side as well as the pharmaceutical industry’s top global companies. The meeting covered all the hot topics in microbiology and gave updates on regulation and best practice in contamination monitoring, prevention, identification and risk assessment.
Di Morris, the keynote speaker who was for many years an MHRA inspector but is now with Pharma Solutions, gave advice on the investigation of anomalies known as out-of-specification (OOS) events. She covered many aspects of the procedures that need to be followed when OOS events occur and emphasised the need to monitor and trend data to show that the manufacturing system is properly under control. ‘There is no such thing as normal flora,’ said Morris. ‘You need to know where it is from, how did it get there and how to control it.
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