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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Table of Contents:

1. Introduction
2. Glossary of Terms
3. Classical Microbiology and the Move Toward Alternative and Rapid Methods
4. Technology Review
5. The Validation Process
6. Implementation: Guidance on Site Commissioning Versus Initial Validation
7. References

Figures and Tables Index