Industry One-Voice-of-Quality Solutions Management Review of Post-Approval Changes Guide

References

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   ICH Harmonised Tripartite Guideline Pharmaceutical Quality System, Q10. Pharmaceutical Quality System. ICH Q10. https://database.ich.org/sites/default/files/Q10%20Guideline.pdf (accessed January 1, 2021).
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   1. Ramnarine E,
   2. Vinther A,
   3. Bruhin K,
   4. Tovar C,
   5. Colao M. P.

   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). PDA J. Pharm. Sci. Technol. 2020, 75.
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   ICH Harmonised Guideline, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, Q12. Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. ICH Q12. https://database.ich.org/sites/default/files/Q12_Guideline_Step4_2019_1119.pdf (accessed January 1, 2021).