FDA Guidance on Alternative Sterility Testing

GMP News
28 February 2008

FDA Guidance on Alternative Sterility Testing

The recently published Draft Guidance on Rapid Microbiological Methods (RMMs) for Sterility Testing of Cellular and Gene Therapy Products provides recommendations on the validation of growth-based RMMs in detail. It is the aim of the document to facilitate the implementation of an RMM for sterility testing.

Although this guidance has been designed for Cellular and Gene Therapy Products it is stated that “Some of the principles of RMM validation discussed in this guidance might also be applicable to products other than cellular and gene therapy products that are subject to sterility testing under 21 CFR 610.12.”

Apart from general recommendations on validation aspects (e.g. risk assessment, limit if detection, specificity, ruggedness, robustness) the document provides a comprehensive list of different categories of micro-organisms that should be included in the study:

  • Gram-negative bacteria

  • Gram-positive bacteria

  • aerobic bacteria

  • anaerobic bacteria

  • yeast

  • fungi

  • isolates detected in starting materials

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