Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS):Through Enhanced Science and Risk-Based Approaches Changes to Analytical Equipment/Instrumentation that are Deemed Equivalent

Authors

Emma Ramnarine, Technological University Dublin
Richard Rolke, CMC Small Molecule Market Products
Kevin O'Donnell, HPRA

Recommended Citation

Ramnarine, Emma; Rolke, Richard; and O'Donnell, Kevin (2020) "Effective Management of Post-Approval Changes in the Pharmaceutical Quality System (PQS):Through Enhanced Science and Risk-Based Approaches Changes to Analytical Equipment/Instrumentation that are Deemed Equivalent," Level 3: Vol. 15: Iss. 2, Article 1.
doi:https://doi.org/10.21427/2zjh-b303
Available at: https://arrow.tudublin.ie/level3/vol15/iss2/1

DOI

https://doi.org/10.21427/2zjh-b303

Creative Commons License

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