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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Handling of Returned Raw & Packing Material – SOP

Standard Operating Procedure (SOP) for Handling of Raw material and Packing Material returned from different sections of the manufacturing/production department to stores/warehouse. Handling of Returned Raw and Packing Material  1.0 …

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Site Master File (SMF) Preparation SOP & Guideline

Standard Operating Procedure (SOP) and Guideline for preparation, approval, and revision of Site Master File (SMF). The Site Master File (SMF) Document shall contain specific information about the quality management…

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