Thursday, 7 August 2014

Pharmacopeial Forum 40 (4) – items of interest

Pharmacopeial Forum 40 (4) – items of interest

Items of interest are:

General chapters

111: Design and Analysis of Biological Assays (Revision proposal target, USP38-NF33 2nd Supplement)

Completely revised after the introduction of four new general chapters pertinent to bioassays.

1223:   Validation of Alternative Microbiological Methods (Revision proposal target, USP38-NF33 2nd Supplement)

This proposed revision provides guidance on the selection and implementation of assay methodologies to serve as alternatives to compendial microbiological methods. The revised chapter describes important steps that should be taken to evaluate candidate alternative methods, to select the analytical technology, and ultimately to qualify the method with actual product. These steps include, but are not limited to, identification of a potentially suitable alternative methodology, demonstration that the method is equivalent and applicable as a replacement for a standard compendial method, development of user specifications for equipment selection, and qualification of the method in the laboratory. In addition, this chapter outlines four distinct options for demonstrating equivalence.

Posted by Tim Sandle

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