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)
Posted by Tim Sandle