RAPIDS METHODS - Accelerate the Implementation and Use of Rapid Methods
PDA Europa Pharmacopeia Conference • Vienna Austria • 2018
The validation of the alternative and rapid microbiological methods are regulated by the United States Pharmacopeia chapter <1223>. Validation of alternative Microbiological Methods; the European pharmacopeia chapter 5.1.6 Alternate Methods for control of microbiological quality, and Rapid Microbial Method of the Japanese Pharmacopeia JP17, mainly.
However, the implementation of such kind of technologies remains difficult in user’s labs due to the numerous steps, limiting their usage despite the high added value of these methods in the quality control of products, process facilities and all together increasing patient safety. Hence, we propose to discuss the possibility to transfer part of the Validations steps into the suppliers responsibility and limit the users responsibility to the suitability testing, in the light of the successful implementation of the ScanRDI™ microbial analysis solution that is compliant with all the specific requirements for a quantitative and qualitative test as defined by the regulatory texts. The discussion will include :
- Regulatory requirements for laboratories,
- Regulated access to validation reports,
- Best practice for approval by regulatory bodies,
- Limitations of existing methods.
This presentation will summarize the experience acquired after many years of usage by our lab of the ScanRDI™ microbial analysis solution. We will discuss the basic principles, the workflow, the drawback and the use of the ScanRDI™ system.