title: Taking control: the Validation Master Plan.
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.
authors.affiliation: Donawa and Associates Ltd., Rome, Italy.
authors.forename: M E
authors.initials: ME
authors.lastname: Donawa
mesh_terms: D001698:Biomedical Engineering / Q000331:legislation & jurisprudence*; D004868:Equipment Failure; D004869:Equipment Safety / Q000592:standards; D004864:Equipment and Supplies / Q000592:standards*; D011786:Quality Control; D014481:United States; D014486:United States Food and Drug Administration