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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