USP Postpones Chapter 1223 Revision Conference Until 2015

The USP has cancelled its September 2013 conference on the revision to Informational Chapter 1223, Validation of Alternative Microbiological Methods. The conference will now take place sometime in 2015.  The reasons for this delay are unknown, but it was understood by the scientific community that a draft revision was to be available for public comment this summer.

The conference was intended to focus on new and revised information on the validation of alternative microbiological methods, validation of alternative methods to antibiotic microbial assays and the current status of USP’s work on rapid/modern microbiological methods.

Topics may include:

Revisions to General Chapter <1223>, Validation of Alternative Microbiological Methods

• Validation Criteria
• Equivalence Approaches for Alternative Qualitative and Quantitative  Microbiological Methods
• Statistical Tools

New Chapter <1223> Validation of Alternative Methods to Antibiotic Microbial Assays

• Validation Criteria/Bridging Studies for Simple and Complex Antibiotics
• Data Evaluation/Statistical Tools

Proposed Draft Chapter on Modern/Rapid Sterility Tests

• Criteria used for selection of proposed method(s)
• Proof of Concept Studies
• Collaborative Laboratory Studies
• Current Status

On a related note, the industry continues to wait for the revision to Ph. Eur. Chapter 5.1.6, Alternative Methods for Control of Microbiological Quality.  There is no known date for a draft to be made available for review and comment; however, some in the industry are hopeful that a draft will be forthcoming later this year.

In the absence of compendial guidance on this topic, the industry should turn to PDA Technical Report No. 33, Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods, which was revised and published in 2013.