PDA Microbiology Conference Update: Revision of USP 1223

USP Chapter 1223, Validation of Alternative Microbiological Methods, has been under revision for at least the past year. During today’s conference, Tony Cundell, Director, Analytical Sciences Microbiology, Merck Research Laboratories and Vice-Chair, USP General Chapters – Microbiology Expert Committee, provided an update to the chapter’s revision process and what we should see when the draft is published in a future issue of the Pharmacopeial Forum.

The revised chapter will most probably reduce or eliminate the prescriptive guidance that is currently found within the existing chapter. This will allow users of alternative or rapid technologies to have more flexibility in the validation and use of these novel systems. Here is an overview of the proposed changes:

• Will include wider discussions of instrument and method validation and address the relationship of alternate methods to the USP General Notices and other relevant chapters
• Address regulatory requirements
• Will introduce concepts of performance, results and equivalence to existing methods
• Considerations for QC product release assays versus referee tests
• Provide guidance on alternate methods for compendial microbial tests
• Will consider equipment selection and qualification with actual product
• User specifications
• Installation, operational and performance qualification considerations
• Better define specificity, limit of detection, ruggedness and robustness, and other validation criteria for qualitative and quantitative technologies
• The responsibility of end-users versus instrument suppliers
• Method suitability
• Statistical tools
• References

And don't look for recommendations on the best rapid method for a specific application, as there is no plan to include any additional discussions regarding scientific principles or proprietary technologies.

PDA Technical Report #33, Evaluation, Validation and Implementation of New Microbiological Testing Methods, which is also under revision, will fill in the gaps that the future USP 1223 will leave. For example, TR#33 will provide detailed guidance on every step of the validation and implementation process, regulatory guidance from the FDA. EMA and other agencies, business and return on investment considerations, as well as a review of the technical and scientific aspects of technologies that are currently available. The revised TR#33 is planned for completion in 2013.