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.
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DOI: 10.5731/pdajpst.2020.011734
Abstract: Post-approval changes are inevitable and necessary throughout the life of a drug product-to implement new knowledge, maintain a state of control, and drive continual improvement. Many post-approval changes require regulatory agency approval by individual countries… read more here.
Keywords: quality; approval; quality system; post approval ... See more keywords