Why Nobody Wants ICH Q14 — And Why That’s Exactly the Problem
The ICH Guideline Q14 “Analytical Procedure Development” was published in November 2023. This forward-looking and regulatory-savvy document builds upon the content of ICH Q2(R2) “Validation of Analytical Procedures” and incorporates elements from ICH Q8 “Pharmaceutical Development” and ICH Q9(R1) “Quality Risk Management.”
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