PDA Technical Report No. 33, Revised 2013 (TR 33) Evaluation, Validation and Implementation of Alternative and Rapid Microbiological Methods

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.

Fonte: PDA