PHARMACEUTICAL OUT-OF-SPECIFICATION (OOS) INVESTIGATION CHECKLIST

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--- INITIAL ASSESSMENT & CONTAINMENT ---
[ ] Date of OOS Result
[ ] Time of OOS Result
[ ] Batch Number Affected
[ ] Test Parameter OOS
[ ] Actual Result Value
[ ] Specification Limit (Upper)
[ ] Specification Limit (Lower)
[ ] Brief Description of OOS Result
[ ] Material Status (Quarantine) (Quarantined, Not Quarantined)

--- ROOT CAUSE INVESTIGATION ---
[ ] Description of OOS Result & Associated Data
[ ] Batch Record Review Status (Completed, In Progress, Not Applicable)
[ ] Potential Contributing Factors (Select All That Apply) (Raw Material Variation, Equipment Malfunction, Process Deviation, Personnel Error, Analytical Method Issue, Environmental Factor)
[ ] Raw Material Lot Number
[ ] Date of Raw Material Receipt
[ ] Details of Equipment Maintenance Records Review
[ ] Analytical Method Validation Status (Valid, Expired, Needs Revalidation)

--- CORRECTIVE ACTION PLAN (CAP) ---
[ ] Detailed Description of Corrective Action
[ ] Estimated Cost of Corrective Action
[ ] Planned Completion Date
[ ] Responsible Department (Manufacturing, Quality Assurance, Engineering, Procurement)
[ ] Action Priority (High, Medium, Low)
[ ] Affected Areas/Equipment (Raw Material A, Equipment X, Process Step Y)
[ ] Prepared By (CAP Initiator)

--- VERIFICATION & VALIDATION ---
[ ] Verification Start Date
[ ] Verification End Date
[ ] Number of Batches Verified
[ ] Number of Failed Batches (During Verification)
[ ] Verification Outcome (Successful, Partial Success, Unsuccessful)
[ ] Detailed Verification Results & Observations
[ ] Verification Lead Signature

--- DOCUMENTATION & RECORDS ---
[ ] Investigation Protocol Number
[ ] Date of OOS Result
[ ] Time of OOS Result
[ ] Batch Number
[ ] Raw Data/Analytical Records
[ ] Supporting Documentation (e.g., Certificates of Analysis)
[ ] Investigator Signature
[ ] Document Review Status (Not Reviewed, Reviewed, Approved)

--- TREND ANALYSIS & PREVENTATIVE ACTIONS ---
[ ] Number of OOS results in last 12 months
[ ] Identified trends from OOS data? (Yes, No, Unclear)
[ ] Description of identified trends and potential root causes.
[ ] Potential preventative actions considered (select all that apply) (Process Improvement, Equipment Maintenance, Training Enhancement, Supplier Qualification, Raw Material Specification Review)
[ ] Estimated cost of implementing preventative actions
[ ] Target completion date for preventative actions
[ ] Justification for selected preventative actions and their expected impact
[ ] Preventative actions deemed sufficient? (Yes, No, Further investigation needed)

--- CLOSURE & SIGN-OFF ---
[ ] Date of Final Review
[ ] Time of Final Review
[ ] Overall Assessment (Satisfactory/Unsatisfactory) (Satisfactory, Unsatisfactory)
[ ] Summary of Review Findings & Justification (if applicable)
[ ] Reviewer Signature
[ ] Reviewer Name (Printed)
[ ] Reviewer ID (Employee Number)

--- END OF TEMPLATE ---
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