Destin A. LeBlanc,Cleaning Validation Technologies, Technical Consulting Services The questions that will be addressed in the Cleaning Memo include:“When should I measure endotoxin in a cleaning validation protocol?”“How should I sample for endotoxin?”“What acceptance criterion should I establish for endotoxin?”
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validation refers to establishing documented evidence that a process or system, when operated within established parameters, can perform effectively and reproducibly to produce a medicinal product meeting its pre-determined specifications and quality attributes
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Pharmaceutical Validation Documentation Requirements
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