PHARMACEUTICAL CLEANING DEVIATION INVESTIGATION CHECKLIST

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--- DEVIATION IDENTIFICATION & INITIAL ASSESSMENT ---
[ ] Date of Deviation Discovery
[ ] Time of Deviation Discovery
[ ] Brief Description of Deviation
[ ] Initial Severity Assessment (e.g., Minor, Moderate, Major) (Minor, Moderate, Major)
[ ] Reporting Source (e.g., Operator, QA, Maintenance) (Operator, QA, Maintenance, Other)
[ ] Deviation Number/ID (if assigned)
[ ] Equipment Location (Area/Room)
[ ] Initial Assessment Sign-off

--- DEVIATION DETAILS & SCOPE ---
[ ] Deviation Reference Number
[ ] Date of Deviation Occurrence
[ ] Time of Deviation Occurrence
[ ] Equipment ID/Name
[ ] Detailed Description of Deviation
[ ] Affected Product(s)/Batch(es) (Product/Batch 1, Product/Batch 2, Product/Batch 2)
[ ] Quantity Affected (if applicable)
[ ] Initial Assessment of Impact

--- ROOT CAUSE ANALYSIS ---
[ ] Describe the observed cleaning failure (e.g., visual residue, analytical data).
[ ] Potential Contributing Factors (Select all that apply) (Inadequate Cleaning Procedure, Incorrect Cleaning Agent, Equipment Malfunction, Operator Error, Insufficient Rinse, Incorrect Water Quality)
[ ] Detailed explanation of the investigation performed to identify the root cause.
[ ] Temperature during cleaning (if applicable)
[ ] Date of Cleaning Event
[ ] Root Cause Category (Select one) (Procedure, Equipment, Material, Training)
[ ] Specific evidence supporting the identified root cause (e.g., analytical reports, observation logs).

--- CORRECTIVE ACTION PLAN (CAP) ---
[ ] Detailed Description of Immediate Corrective Action Taken
[ ] Date Corrective Action Initiated
[ ] Time Corrective Action Initiated
[ ] Quantity of Cleaning Agent/Solution Used (if applicable)
[ ] Method of Cleaning (e.g., Manual, Automated) (Manual, Automated)
[ ] Signature of Person Performing Corrective Action
[ ] Supporting Documentation (e.g., Photos, Cleaning Logs)

--- PREVENTATIVE ACTION PLAN (PAP) ---
[ ] Detailed Description of Preventative Action
[ ] Affected Cleaning Procedures to Revise (SOP - Equipment Cleaning, Cleaning Log Templates, Training Materials, Cleaning Validation Protocol)
[ ] Frequency of Revised SOP Review (e.g., Quarterly)
[ ] Target Completion Date for Preventative Actions
[ ] Responsible Personnel Signature (PAP)
[ ] Training Required for Personnel? (Yes, No)
[ ] Supporting Documentation (e.g., revised SOP)

--- VERIFICATION & VALIDATION ---
[ ] Verification/Validation Start Date
[ ] Verification/Validation Start Time
[ ] Cleaning Cycle Time Verified (minutes)
[ ] Cleaning Temperature Verified (Â°C)
[ ] Concentration of Cleaning Agent Verified (%)
[ ] Cleaning Validation Method Used (Visual Inspection, ATP Monitoring, Residue Testing)
[ ] Supporting Documentation (e.g., ATP reports, residue test results)
[ ] Validation Analyst Signature

--- DOCUMENTATION REVIEW & APPROVAL ---
[ ] Document Review Date
[ ] Summary of Document Review Findings
[ ] Document Accuracy Assessment (Accurate, Minor Discrepancies, Significant Discrepancies)
[ ] Reviewer Signature
[ ] Reviewer Name (Printed)
[ ] Document Version Number
[ ] Approval Status (Approved, Rejected, Pending Revision)

--- BATCH IMPACT ASSESSMENT ---
[ ] Summary of Potential Product Impact
[ ] Number of Potentially Affected Batches
[ ] Batch Status Review Required? (Yes, No)
[ ] Affected Product Attributes (e.g., sterility, assay, impurities) (Sterility, Assay, Impurities, Appearance, Other)
[ ] Date of Next Stability Testing (if applicable)
[ ] Recall Action Required? (Yes, No)
[ ] Justification for Recall Decision (if applicable)

--- CLOSURE AND SIGN-OFF ---
[ ] Closure Date
[ ] Investigator Signature
[ ] Quality Assurance Reviewer Signature
[ ] Deviation ID/Reference Number
[ ] Summary of Findings & Conclusions
[ ] Deviation Status (Closed, Pending, Reopened) (Closed, Pending, Reopened)

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