By Kevin Lombardi, Nasir Egal

Published in: IVT Jr GXP Compliance Vol 25, Issue 1

Published on: January 26, 2021

Abstract: Post-approval changes (PACs) 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) 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 paper provides a practical application of the concepts described in ICH Q9, Quality Risk Management, ICH Q10, Pharmaceutical Quality System, and ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management to shelf-life extensions for pharmaceutical products.

In this case study, the risk associated with the extension of shelf-life was evaluated. The conclusion drawn is that shelf-life extension changes when controlled effectively as described in this paper, present a low risk to product quality, and therefore can be downgraded from a prior-approval to notification or annual reportable and managed in the PQS with immediate implementation.

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