ICH E6 (R3) introduces a dedicated section on data governance, reflecting the increasing complexity of data sources and ...
Experts have recommended ICH Q10 PQS (International Council for Harmonisation - Pharmaceutical Quality System) guidelines on pharma quality systems for effective implementation of revised Schedule M ...
The International Conference on Harmonisation’s (ICH) Good Clinical Practice (GCP) guideline (E6) is ripe for review, according to the vast majority of respondents to a members’ poll by the UK-based ...
Analytical characterization is vital for product quality, manufacturing control, and regulatory compliance in biopharmaceutical development. ICH Q6B outlines structural characterization requirements, ...
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