Draft USP Chapter 1223 Validation of Alternative Microbiological Methods published

With the GMP News from 21. November 2012 we informed you about the status of the revision of USP chapter 1223, Validation of Alternative Microbiological Methods. Now the USP published a draft of the document.

The draft provides guidance with regard to the selection and implementation of appropriate methods, i.e. important steps for the evaluation of possible methods, for the selection of the analytical technology and finally for the qualification with regard to a current product. In this context the chapter includes information about demonstration that the new method is comparable to the compendial method, and about applicability as a replacement for an existing method. Furthermore the document provides information about the qualification of a method in the laboratory.

The public can provide comments on the draft chapter 1223 until September 30, 2014. The draft chapter can be found at USP website. You are required to register to gain access to the USP PF online, but this is a free service to the pharmaceutical community.