
Implementing monitoring programs and objective measurement tools can help address gaps in Annex 1 compliance. What remains is embedding those tools within a program architecture designed to generate, interpret, and act on objective data systematically, across the full life cycle of the contamination control strategy (CCS). This article highlights what a well-constructed Annex 1-compliant program looks like at each stage, from gap assessment through governance, and how USP measurement tools integrate at each step.
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