Process validation: How much to do and when to do it
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Gail Sofer | Anurag S. Rathore | Joseph F. Noferi | Edward R. Arling | Peter Watler | Rhona O'leary | A. Rathore | G. Sofer | P. Watler | J. F. Noferi | R. O'leary
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[2] J Ellis,et al. Validation of critical process input parameters in the production of protein pharmaceutical products: a strategy for validating new processes or revalidating existing processes. , 2000, PDA journal of pharmaceutical science and technology.