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PubMed · 10158118

Taking control: the Validation Master Plan.

M E Donawa
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Abstract

Companies preparing for compliance with the European quality system standards and US Good Manufacturing Practice regulations must comply with the process validation requirements that apply to their manufacturing processes. Effective planning for compliance is fundamental for companies with processes that must be validated, monitored, and controlled. This article discusses the basic elements of a Validation Master Plan, which can greatly facilitate this planning process.

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Biomedical EngineeringEquipment FailureEquipment SafetyEquipment and SuppliesQuality ControlUnited StatesUnited States Food and Drug AdministrationJournal Article

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M E Donawa. 1995. Taking control: the Validation Master Plan.. https://pubmed.ncbi.nlm.nih.gov/10158118/

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