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 . Furthermore, this 1VQ position 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 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.
"Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS):Through Enhanced Science and Risk-Based Approaches: Shelf-Life Extensions for Pharmaceutical Products,"
2, Article 16.
Available at: https://arrow.tudublin.ie/level3/vol15/iss2/16
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