Thursday, 20 July 2017

European Pharmacopoeia revises Biological Indicator Chapter


The general chapter in the European Pharmacopoeia (5.1.2) relating to biological indicators has undergone a significant revision. The new version has been issued with the release of supplement 9.2 to the 9th edition of the pharmacopoeia (1). The changes to the chapter are signaled by the revision to the title, which now becomes “Biological indicators and related microbial preparations used in the manufacture of sterile products”. Previously the chapter was headed “Biological indicators of sterilization.” The change of title reflects the adaption of the chapter to take into account microbial preparations used for sterilization grade filtration. This article assesses the key changes.

The reference is:

Sandle, T. (2017) European Pharmacopoeia revises Biological Indicator Chapter, GMP Review, 16 (1): 4-6

For a copy, please contact Tim Sandle

Posted by Dr. Tim Sandle