Applications in pharmaceutical industry Ultrapure water

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ultrapure water system validation process flow


ultrapure water , deionized water validation


ultrapure water validation must utilize risk-based lifecycle approach. approach consists of 3 stages – design , development, qualification , continued verification. 1 should utilize current regulatory guidance comply regulatory expectations. typical guidance documents consult @ time of writing are: fda guide inspections of high purity water systems, high purity water systems (7/93), emea cpmp/cvmp note guidance on quality of water pharmaceutical use (london, 2002) , usp monograph <1231> water pharmaceutical purposes


however other jurisdictions documents may exist , responsibility of practitioners validating water systems consult those. world health organization (who) pharmaceutical inspection co-operation scheme (pic/s) developed technical documents outline validation requirements , strategies water systems.





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