The Validation of disinfectants has come into focus for pharmaceutical manufacturers, especially with the new Annex 1 of the GMP guidelines. Can Data collected by disinfectant manufacturers to register the products under the BPR (Biocidal Products Regulation) be helpful here?
There are several EN standards available to test for disinfectant efficacy. How pharma-realistic are these methods and what are the differences to validation studies?
We will discuss challenges of method-development for registration versus validation.