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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Incident Handling and Investigation Procedure – EHS

Standard Operating Procedure (SOP) for Handling, Investigation, Classification and Reporting of Incident by Environmental,  Health and Safety (EHS) department in pharmaceuticals. Incident Investigation, Classification and Reporting (EHS) 1.0   PURPOSE: To…

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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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