How do you validate and maintain a WFI storage and distribution...

Pubblicato 2026-04-03 02:23:57

Validation approach (FDA/ICH Q7):

Phase	Duration	Activities
Phase 1 (initial)	2–4 weeks	Intensive monitoring of all POUs daily; establish operating ranges and sanitization frequency
Phase 2	2–4 weeks	Refine procedures; demonstrate consistent quality
Phase 3 (long-term)	Up to 1 year	Routine monitoring (weekly or monthly); prove robustness across seasonal changes

Key acceptance criteria:

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