Analytical Method Transfer (USP 1224) Guideline

Analytical Method Transfer (also called ‘Method Transfer’): A documented process that qualifies a laboratory (i.e., the Receiving Unit) to use an analytical test procedure that originated in another laboratory (i.e.,…

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Investigation Tools used in Pharma – SOP & Guideline

The investigation related to quality-related events that occur from cGxPs approved specifications, and/or procedures including but not limited to Protocols, Master Batch Records (MBR), Batch Packaging Records (BPR), breakdowns, facilities,…

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