Quality Oversight in Sterile Manufacturing - Live Online Training including 4 Case Studies

In the „Guidance for Industry - Sterile Drug Products Produced by Aseptic Processing“ published in 2004, the FDA clearly formulated the expectations for Quality oversight. The aim should be to ensure regular and independent checks of the processes and personnel involved in aseptic manufacturing and thus reduce the risk of product contamination. In several warning letters in recent years, companies have been criticised for insufficient „quality oversight“.

In addition, against the background of new or revised European regulations, e.g. Annex 1 or Annex 15,

EU GMP Guide Annex 15 „1.3 ...However, there should be appropriate quality oversight over the whole validation life cycle“.

every European company faces the question of how the American demands for Quality Oversight will also be taken up in the regulatory environment here in the future.

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