Industry One-Voice-of-Quality (1VQ) Solutions: Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS)—through Enhanced Science and Risk-Based Approaches

References

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   1. Vinther A.,
   2. Ramnarine E.

   Solving the Global Continual Improvement and Innovation Challenge: How an Effective Pharmaceutical Quality System Can Transform Post-Approval Change Management. PDA J. Pharm. Sci. Technol. 2019, 73 (5), 517–521.

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2. 2.↵
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3. 3.↵
   International Conference for Harmonisation, Quality Guideline Q10: Pharmaceutical Quality System. ICH: Geneva, 2008.
4. 4.↵
   Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S), PIC/S Recommendation on How to Evaluate/Demonstrate the Effectiveness of a Pharmaceutical Quality System in Relation to Risk-Based Change Management. PIC/S: Geneva, 2019.
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   International Conference for Harmonisation, Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2005.
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