A question that may be raised by industry professionals is, “How does the upcoming ICH Q14 guideline impact the methods that I currently use?” The FDA’s July 2015 Guidance for Industry: “Analytical Procedures and Method Validation for Drugs and Biologics” references analytical method development, the use of statistical tools during method validation, and life cycle management of analytical procedures. It is recommended that for in-use methods there is a program for periodic assessment of the method performance/capability where continued method suitability is confirmed.

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