By Emma Ramnarine, Richard Rolke

Published in: IVT Quality & Validation

Published on: December 16, 2020

Abstract: Post-approval changes are inevitable and necessary throughout the lifecycle of pharmaceutical products to implement new knowledge, maintain a state of control, and drive continual improvement.

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.

Furthermore, this 1VQ position paper provides a practical application of the concepts described in ICH Q9, Quality Risk Management [2], ICH Q10, Pharmaceutical Quality System [3], and ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management [4] to changes to analytical equipment/instrumentation that are deemed to be equivalent.

This paper describes changes to analytical equipment that are considered ‘like for like’ or equivalent. The conclusion drawn from this case study is that such changes present a low risk, and therefore can be downgraded from a prior-approval and managed only within the company’s PQS.

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