Our latest newsletter provides an overview of the proposed changes to three RMM validation guidance documents: PDA Technical Report No. 33, USP chapter 1223 and Ph. Eur. chapter 5.1.6. These include an enhanced understanding of the use of statistics, technology updates and regulatory acceptance. To read this overview, please sign up to receive our FREE newsletter by clicking on the following link: http://rapidmicromethods.com/newsletter/.
- Scientific Principles
- _Growth-based Methods
- _Viability Staining and Laser Excitation
- _Detection of Cellular Components
- _Optical Spectroscopy
- _Nucleic Acid Amplification
- _MEMs
- Product Matrix
- How to 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