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Search results with tag "Critical process parameters"
Questions and Answers: Improving the understanding of …
www.ema.europa.euMaterial attributes and process parameters that can affect quality, but are not described by ranges in the DSp would need to be controlled by their specification or target/NOR, respectively. ... extension of the range of existing material attributes or critical process parameters. If the change has been foreseen as described in an approved post ...
Critical Quality Attributes, Critical Process Parameters ...
www.dcvmn.orgCritical Quality Attributes, Critical Process Parameters, Tracking and Trending Rajesh K. Gupta, Ph.D. Biologics Quality & Regulatory Consultants, LLC Analyze, Strategize & Operate – Different & Smart rgupta@bqrc.org 1 240 246 0126 DCVMN Training Workshop – Hyderabad, India April 4 – 8, 2016 Biologics Quality & Regulatory Consultants, LLC