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…

Continue Reading Regulatory Audit : Preparation & Handling

Technical Agreement – Preparation & Handling

Standard Operating Procedure for preparation and handling of different types of Technical Agreement. Agreement undertook by written and legally binding on two parties (Contract giver and contract acceptor). Technical Agreement…

Continue Reading Technical Agreement – Preparation & Handling

Audit Checklist – Department wise in Pharmaceuticals

Audit Checklist (s) for different department/section/area like - Engineering / maintenance, HVAC Area, Purified water system, Quality Control, Warehouse, Granulation, Compression, Coating, Packing / Packaging, Personal and administration (HR), Microbiology…

Continue Reading Audit Checklist – Department wise in Pharmaceuticals