PDA Technical Report No. 33, Revised 2013 (TR 33)

Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods (print version)

Microbiological testing plays an ever-increasing role in the pharmaceutical laboratory. The majority of testing performed today relies on century-old, conventional methods based on the recovery and growth of microorganisms using solid or liquid microbiological growth media. However, they are often limited by slow microbial growth rates, the unintended selectivity of microbiological culture, and the inherent variability of microorganisms in their response to culture methods.

In spite of the limitations of classical culture methods, acceptance of alternative and potentially superior methods has only started to gain momentum within the pharmaceutical, biotechnology and medical device industries. We believe this continues to be due in part to a lack of clear guidance regarding the demonstration of their equivalence to existing methods acceptable to regulatory agencies and validation of the equipment associated with the alternative methods.

Technical Report No. 33, Revision 2013 (TR 33):Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods is intended to provide guidance for the successful evaluation, validation, and implementation of alternative and rapid microbiological methods needed by the pharmaceutical, biotechnology and medical device industries to assure product quality. This technical report was written to establish industry-wide criteria on what constitutes an acceptable alternative or rapid microbiology test to the compendial or classical method and how to prove it to the satisfaction of quality organizations and regulatory agencies.

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