Handling of Outliers in Near Infrared (NIR) Analysis
Standard Operating Procedure (SOP) & guideline for the Handling of Outliers or aberrant or Out of Specification test result in Near Infrared (NIR) Analysis. Handling of Outliers in Near Infrared…
Guideline for Equipment and System Qualification
Standard Operating Procedure (SOP) and Guideline for preparation of Equipment / System Qualification (URS, IQ, OQ, PQ, FAT, SAT, etc.) documents, execution of Qualification activities, Review and Compilation of data,…
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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