Reprocess Rework of API and Drug Product

Guidance (SOP) about the procedure and documentation of reprocess and rework during Active Pharmaceutical Ingredient (API), excipients, and Drug Product in Pharmaceuticals. Guideline for Reprocess / Rework of API &…

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Regulatory Audit : Preparation & Handling

Standard Operating Procedure (SOP) / Guideline for Preparation and Handling of Regulatory Audit (FDA Inspection) in Pharmaceutical Drug Manufacturing Plant. Handling of Regulatory Audit (FDA Inspection) 1.0   PURPOSE The purpose…

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User Requirement Specification (URS) Handling SOP

Standard Operating Procedure (SOP) for Handling of User Requirement Specification (URS) for a computerized system or Instrument / Equipment. User Requirement Specification (URS) is a document that informs the software…

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