JVT

A Spectrum of Importance—Challenging the Concept of Critical/Non-Critical in Qualification and Validation Activities | IVT

This paper challenges the current approach to classifying process parameters and quality attributes as being critical or non-critical.  It discusses how this binary approach is probably overly simplistic, and that it may not adequately reflect science and risk-based thinking.  The problems presented by defective medicines and product recalls are discussed. 

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