PHARMACEUTICAL VALIDATION CHECKLIST TEMPLATE

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--- PLANNING & SCOPE DEFINITION ---
[ ] Project Objective
[ ] Scope Description (Inclusions & Exclusions)
[ ] Validation Type (e.g., Prospective, Concurrent, Retrospective) (Prospective, Concurrent, Retrospective)
[ ] Project Start Date
[ ] Estimated Completion Time (in days)
[ ] Critical Process Parameters (Initial Assessment)

--- RISK ASSESSMENT ---
[ ] Process/Equipment Description
[ ] Potential Hazards/Failure Modes
[ ] Likelihood of Occurrence (1-5)
[ ] Severity of Impact (1-5)
[ ] Risk Score (Likelihood x Severity)
[ ] Risk Level (Low, Medium, High) (Low, Medium, High)
[ ] Control Measures/Mitigation Strategies
[ ] Effectiveness of Control Measures (Adequate/Inadequate) (Adequate, Inadequate)

--- DESIGN & SPECIFICATION REVIEW ---
[ ] Describe the intended function of the equipment/process.
[ ] Upload design drawings or schematics.
[ ] Specify critical operating parameters (e.g., temperature, pressure).
[ ] Does the design meet relevant regulatory requirements (e.g., GMP, FDA)? (Yes, No, Not Applicable)
[ ] Explain any deviations from standard designs and justification for these deviations.
[ ] Date of Design Specification Review
[ ] Reviewer Signature

--- INSTALLATION QUALIFICATION (IQ) ---
[ ] Equipment Name
[ ] Manufacturer
[ ] Serial Number
[ ] Installation Date
[ ] Detailed Description of Equipment and Location
[ ] Utilities Connected (Select All That Apply) (Electricity, Water, Compressed Air, Nitrogen, HVAC)
[ ] Installation Vendor
[ ] Installation Technician Signature

--- OPERATIONAL QUALIFICATION (OQ) ---
[ ] Operating Temperature (Minimum)
[ ] Operating Temperature (Maximum)
[ ] Pressure (Minimum)
[ ] Pressure (Maximum)
[ ] Date of First OQ Run
[ ] Start Time of First OQ Run
[ ] Equipment Status After OQ (Operational, Requires Calibration, Requires Repair)
[ ] Observations During OQ Runs
[ ] OQ Execution Signature

--- PERFORMANCE QUALIFICATION (PQ) ---
[ ] Batch Number(s) Tested
[ ] Start Date of PQ Runs
[ ] End Date of PQ Runs
[ ] Number of PQ Batches/Runs Completed
[ ] Summary of PQ Results and Observations
[ ] PQ Criteria Met? (Yes, No, N/A)
[ ] Attachment: PQ Data Reports/Charts
[ ] Signature of PQ Reviewer

--- DOCUMENTATION & RECORDS ---
[ ] Validation Protocol Reference Number
[ ] Validation Protocol Document
[ ] Protocol Creation Date
[ ] Protocol Review Date
[ ] Protocol Reviewer Signature
[ ] Summary of Findings/Deviations
[ ] Report Approval Signature
[ ] Number of Pages in Report

--- CHANGE CONTROL ---
[ ] Date of Change Request
[ ] Description of Change
[ ] Justification for Change
[ ] Impact Assessment (High/Medium/Low) (High, Medium, Low)
[ ] Estimated Implementation Time (Days)
[ ] Affected Systems/Equipment (Equipment A, Software B, Process C, Documentation D)
[ ] Requestor Signature
[ ] Approval Date
[ ] Approval Signature

--- REVIEW & APPROVAL ---
[ ] Review Date
[ ] Reviewer Name
[ ] Review Comments
[ ] Approval Status (Approved, Rejected, Conditional Approval)
[ ] Approval Reason (if rejected/conditional)
[ ] Approver Signature
[ ] Approval Date

--- END OF TEMPLATE ---
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