Monday, 5 February 2018

Revisions made to European Pharmacopoeia sterilisation chapters

Methods of sterilisation and the assessment of sterilisation using biological indicators represent important areas of regulatory concern. The two applicable guidance chapters in the European Pharmacopeia have undergone revisions. This article assesses the main changes. Notably these include reference to the production of sterile products through aseptic processing for the first time; and changes to the assessment of the suitability of biological indicators, including a new recommendation for supplier auditing.

Tim Sandle has written a new article for Clean Air and Containment Review. The reference is:

Sandle, T. (2017) Revisions made to European Pharmacopoeia sterilisation chapters, Clean Air and Containment Review, Issue 32, pp18-20

Posted by Dr. Tim Sandle

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