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Wherever possible, the challenge study should be performed using "worst-case" scenario parameters, i.e., the conditions that would be the most permissive for growth of , challenge studies can be used to validate a treatment or process that aims to reduce or eliminate the presence of the pathogen.Within the context of the GVP inspection program, Market Authorization Holders (MAH) and importers are subject to GVP inspections as their name appears on the label and as such may receive ADRs.The purpose of this guidance document is to provide interpretive guidance to industry on the expectations of inspectors with respect to the adverse drug reaction and post-approval reporting requirements when conducting GVP inspections.These guidelines are designed to facilitate compliance by the regulated industry and to enhance consistency in the application of the regulatory requirements regarding Good Pharmacovigilance Practices.set forth regulatory requirements for manufacturers to report ADRs and to report unusual failure in efficacy of new drugs to Health Canada.




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