Infrastructure Qualification Procedure – Quality IT

Standard Operating Procedure (SOP) for IT Infrastructure Qualification of Computer System used in cGxP environment at the pharmaceutical company. Computer System - IT Infrastructure Qualification 1.0   Objective  This Procedure defines…

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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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Rejection Handling Procedure (API/Drug Product)

Standard Operating Procedure (SOP) for Handling of Interim/On-line Rejection during manufacturing and packing of drug substances or drug product. Handling of Interim/On-line Rejection 1.0   Purpose : To define procedure for…

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