JVT

Changes To Analytical Equipment/Instrumentation That Are Deemed Equivalent

This One-Voice-of-Quality (1VQ) position paper is part of a series of industry case studies intended to demonstrate the standard application of the principles outlined in the publication “Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS) - Through Enhanced Science and Risk-Based Approaches Industry; One-Voice-of-Quality (1VQ) Solutions” in PDA Journal of Pharmaceutical Science and Technology, 2020 [1]. Furthermore, this 1VQ position paper provides a practical application of the concepts described in ICH Q9, Quality Risk Management [2], ICH Q10,...

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