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:
Posted by Dr. Tim Sandle
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