Recent Posts

May, 2023

  • 8 May

    Root Cause Analysis In Pharmaceuticals

    Root Cause Analysis In Pharmaceuticals (RCA) RCA is a systematic process to identify the causal factors that contributed to the occurrence of a harmful event. RCA focuses primarily on systems and processes, not individual performance. Finding and identifying root causes during an investigation adds considerable value by pointing out significant …

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  • 7 May

    Performance qualification protocol cum report

    Performance qualification protocol cum report shall consist of minimum contents but  not be limited to TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description Performance Qualification Procedure Training Date Performance Qualification Results for Run-1 Performance Qualification Results for Run -2 Performance Qualification Results for Run-2 Deficiency (if any) and …

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  • 7 May

    Operation cum performance qualification protocol cum report

    Operation cum performance qualification protocol cum report shall consist of minimum contents,but not limited to. TITLE Pre Approval Overview Purpose Background Responsibility Requalification System Description Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Performance Qualification Results Deficiency (if any) …

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  • 7 May

    Cleaning validation

    Cleaning validation consists of the following:- Protocol No. for cleaning, validation should be written in the format PRT/CLV/ CC/DD.PRT refers to protocol, CLV refers to cleaning validation, and CC refers to Protocol no. DD refers to revision no. of the protocol. Revision No. of the protocol goes through the proper …

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  • 7 May

    Operational qualification protocol cum report

    Operational qualification protocol cum report shall consist of minimum contents but not limited to. Overview Purpose Background Responsibility Requalification System Description Operational Qualification Procedure Training Date Calibration Review Key Functionality Safety Features SOP verification Preventive maintenance procedure verification Operational testing Deficiency (if any) and Corrective Action Report Acceptance criteria Summary …

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