Validation

  • NoProject Planning And Management
    1Preparation of Validation documents, Validation Master Plan (VMP), Equipment Validation Plan (EVP), Risk Assessment (RA), and Impact Assessment (IA)
    2Master Validation / Qualification Schedule

     

    NoDevelopment Of Qualification Protocols – Equipments & Computer System Validation
    1Design Qualification
    2Review of User Requirement Specification (URS) considering the GMP Risk Analysis
    3Review of Functional Design Specification (FDS) of equipment for establishing traceability with URS and GMP Risk Analysis
    4Co-ordinate with vendors/Prepare Factory and Site Acceptance Testing (FAT and SAT) protocols for equipment
    5Co-ordinate with vendors/Prepare Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) Protocols of the said equipment and systems
    6Preparation/ Review of Area/ Facility Qualification Protocols
    7Preparation of Product Microbial Limit Test (MLT), BET, Bio-Burden, & Sterility Method Validation Protocols
    8Preparation of Analytical Method Validation/ Verification Protocols
    9Preparation of Vendor Qualification Protocols for Raw & Packing Materials
    10Preparation of Process Validation Protocols by considering Critical Process parameters, Critical Quality Attributes as per Process Development requirements

     

    NoExecution Of Qualification Process And Final Documentation At Client’s Site
    1Execute the approved IQ, OQ & PQ protocols at client’s site as per approved validation plan and guidelines
    2Compile all reports and complete the documentation in compliance with applicable International regulatory requirements

     

    NoInspection / Fat At Vendors Site
    1Conduct FAT of the systems and equipment at the vendor’s works as required

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