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Rapid Methods Validation Package Contents For EU Countries

Validation packages for RMMs should include the following:

Description of the technique, including application principle
Primary validation (EP 5.1.6) *
Risk benefit analysis *
Validation of equipment (DQ, IQ, OQ) *
Comparative study against pharmacopoeial/traditional method (PQ)
Quality Expert Report by a suitably qualified individual (include CV) *

 

*Areas where BioVigilant can contribute