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Cleaning validation verifies that the cleaning procedure can consistently and significantly reduce the amount of active ingredients, excipients, and cleaning agents to a concentration within the acceptance limit. Why is cleaning validation required? Additional documents included each month. Checkout sample preview s.
This article can help you understand who is responsible for preparing the validation master plan, the stages of the validation life cycle, the risk-based prioritization of validation items, how to prepare a validation schedule, and some practical examples. What is a validation master plan (VMP)?
Additional documents included each month. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. employee assay qualification) must be documented in an SOP for each assay the lab performs with pre-determined acceptance criteria. gown qualification).
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He also stressed the importance of reviewing batch records and analytical records and the need for clear documentation practices. Dr Khurana stressed the importance of risk-based testing and the need for proper documentation. He mentioned the role of quality assurance in ensuring these practices are followed.
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