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3 articles tagged ich.
CQA, CPP and CMA get used interchangeably in PAT documents. Two of the three are formally defined by ICH and the third is not. A working guide to what each term means and where the lines fall.
Each update to an approved chemometric procedure in the EU is a regulatory event. Commission Regulation No 1234/2008 and ICH Q14 determine which variation type applies and whether prior approval is needed.
At its Rio de Janeiro Assembly on 2-3 June 2026, ICH brought E6(R3) Annex 2 to Step 4, extending GCP to decentralised and registry-based trials. Q1 and Q3E remain in draft review.