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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-Voiceof-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, 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. 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.

DOI

https://doi.org/10.21427/gsd5-hk81

Creative Commons License

Creative Commons Attribution-Noncommercial 4.0 License
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