Revision of USP 1223 - current Status

The chapter <1223> Validation of Alternative Microbiological Methods of the USP is still under revision. On October 23, 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.

Dr. Michael Miller, an experienced microbiologist in the field of alternative methods, summarized the talk of Tony Cundell in his blog as follows:

"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."

At the same time, the PDA technical Report No.33, "Evaluation, Validation and Implementation of New Microbiological Testing Methods" is as well under revision. Together with the current revision of the EP chapter for alternative methods, we will hopefully have three helpful documents for the implementation and validation of alternative Microbiological methods in the near future.

Compiled by
Axel H. Schroeder
Administration Manager
ECAs RMM Working Group

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