This technical report presents a holistic approach for performing a microbiological investigation. It provides a framework to assist with focusing on the investigational areas that may contain or contribute to the root cause of data deviations, such as sampling, test methodology, and suitability of the test, as opposed to providing methods for analysis of batch acceptability.
The distinct areas where microbial data is collected and inspected for deviation investigations are the focus of this document, including:
1) Roles and responsibilities of personnel, especially microbiologists, in the laboratory investigations and cross-functional teams responsible for manufacturing investigations,
2) Conducting laboratory investigations, and
3) Conducting manufacturing investigations.
The roles of other contributors to deviation investigations required for effective root cause analysis, such as representatives from manufacturing, process engineering, and quality assurance, are also briefly described.
This technical report promotes a lifecycle approach, but greater emphasis is placed on laboratory and manufacturing investigations of marketed drug products.
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Table of Contents:
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- Glossary of Terms
- Microbiologist Roles and Responsibilities
- Phase I: Conducting the Microbiology Laboratory Investigation
- Phase II: Manufacturing Investigation
Figures and Tables Index