Overview: Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method.
This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities.
Rapid microbiological methods (RMMs) have been implemented by a number of companies around the world. In some cases, it is necessary to work with regulatory authorities in order to effectively introduce a RMM in place of an existing microbiology method. This is especially true if the existing method is incorporated in a previously approved regulatory dossier, such as a New Drug Application (NDA) or Marketing Authorization. There are different perspectives on RMM validation, submission and implementation strategies, depending on the regulatory body your products are registered with, and/or which local inspectorate is responsible for conducting GMP audits at your manufacturing facilities.
Areas Covered in the Session: - Review current regulatory status of rapid method acceptance
- Regulatory publications and presentations focusing on RMM implementation
- Current perspectives from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), Australian Therapeutic Gods Administration (TGA) and the Japanese Pharmaceutical and Medical Devices Agency (PMDA)
- Use of comparability protocols
- Submission strategies
- Concept of research exemptions
Who Will Benefit: - Microbiology
- Quality Control
- Quality Assurance
- Manufacturing
- Validation
- Regulatory Affairs
- R&D
- Discovery
- Finance
