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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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…

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Programmable Logic Controller (PLC) Qualification

Protocol and Procedure for Installation Qualification of Programmable Logic Controller (PLC) connected with Manufacturing Equipment. Installation Qualification of Programmable Logic Controller (PLC) 1.0   Objective : The objective of this protocol…

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