Post-approval Change Submission: ICH Q12 Impact Analysis on India and Japan
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DOI: 10.36468/pharmaceutical-sciences.617
Abstract: The present research provides a discussion on post approval change management of pharmaceuticals, biologics and drug device combinations, which is an important part of life cycle management. The present study focuses on understanding the existing… read more here.
Keywords: india japan; post approval; approval change; ich q12 ... See more keywords
Knowledge Management as a Pharmaceutical Quality System Enabler: How Enhanced Knowledge Transfer Can Help Close the ICH Q10 to ICH Q12 Gap
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DOI: 10.5731/pdajpst.2020.011825
Abstract: Knowledge management (KM) is identified in ICH Q10 (Pharmaceutical Quality System), as a key enabler to the pharmaceutical quality system (PQS). ICH Q8 (Pharmaceutical Development), ICH Q11 (Development and Manufacture of Drug Substances), and ICH… read more here.
Keywords: knowledge; ich q12; management; ich q10 ... See more keywords