The latest ICH guideline, Q14, complements Q2(R2) for the validation of analytical procedures. Revision of Q2(R1) into Q2(R2) aligns its implementation with Q14(1), ensuring coherence between both ...
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 ...
The pharmaceutical regulatory landscape and pharmaceutical development have been reshaped by International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) ...
The updated ICH Q14 guidance from the FDA revising analytical procedures used for release and stability testing has shown higher product quality expectations from regulatory agencies. As analytical ...
Whether you’ve already implemented the recommendations of ICH Q14/Q2(R2) and USP <1220>, or if you’re just getting started, Waters™ Empower™ Chromatography Data System (CDS) is packed full of ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results