Monday, 30 September 2013

Pharmacopeial Forum new editions

Two new editions of the Pharmacpeial Forum has recently been issued (Vol. 39, No.4 and Vol. 39 No.5). Amongst the items of interest are:

Chapter111     Design and Analysis of Biological Assays (Revision proposal target, USP37-NF32 2S)

USP has developed four general information chapters pertinent to bioassays:  1030, 1032, 1033, and 1034. The latter three became official August 1, 2012, and 1030 will become official December 1, 2013. These new chapters largely replace the current general chapter 111. It is now proposed to replace the current 111 with a completely revised 111 that covers a much reduced set of topics appropriate for a chapter numbered below 1000.

Chapter 1240  Virus Testing of Human Plasma for Further Manufacture
(Revision proposal target, USP37-NF32 2S)

Human-plasma-derived products are manufactured from donated human plasma and include many therapeutically important medicines. The scope of this new general information chapter is virus testing performed on human plasma for further manufacture of pharmaceuticals. The chapter also contains an Appendix with regulatory guidances and references that support the recommendations.

Chapter 791    pH (Revision proposal target, USP37-NF32 2S)

This chapter is being updated to include contemporary terminology and modern operating procedure of pH sensors and measuring systems, to increase flexibility in the selection of pH buffers used for calibration, and to harmonize the calibration requirements with European Pharmacopoeia. There is a change in the calibration procedure and performance requirement to support a harmonized method and accuracy.

Posted by Tim Sandle