We have recently updated a number of our RMM scientific tutorial and regulatory pages. These include enhanced discussions on nucleic acid amplification technologies (NAAT), FDA's recent final rule on sterility test requirements for biological products, and EMA's Post Approval Change Management Protocol (PACMP), to name a few. Our Reference page has also been updated to include many rapid method publications from American Pharmaceutical Review, which are now in a format suitable for printing or download.
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- Validate
- Regulatory
- _Annex 1 Revision
- _Rapid Sterility Testing of ATMPs
- _Changing Acceptance Levels
- _US Food and Drug Administration (FDA)
- _European Medicines Agency (EMA)
- _Australia TGA
- _Japan PMDA
- Recent Posts