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 ICH guidance document on Validation of Analytical Procedures, ICH Q2, has been updated to Q2(R2). A new ICH guidance document on Analytical Procedure Development, Q14, has been introduced. The ...
Last week, the U.S. Food and Drug Administration (FDA) issued draft guidance on Good Clinical Practice (GCP), adopting the International Council for Harmonisation’s (ICH) “E6(R3)” guidelines. Below we ...
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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