PHARMACEUTICAL DEVIATION MANAGEMENT CHECKLIST

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--- DEVIATION IDENTIFICATION & REPORTING ---
[ ] Date of Deviation Occurrence
[ ] Time of Deviation Occurrence
[ ] Detailed Description of Deviation
[ ] Deviation Category (Manufacturing, Equipment, Raw Material, Process, Packaging, Other)
[ ] Severity Level (Minor, Moderate, Major)
[ ] Batch Number (if applicable)
[ ] Reported By (Name)
[ ] Location of Deviation

--- DEVIATION INVESTIGATION ---
[ ] Detailed Description of Deviation
[ ] Possible Root Causes Identified
[ ] Potential Contributing Factors (Equipment Failure, Human Error, Process Out of Control, Raw Material Issue, Documentation Error, Training Deficiency)
[ ] Number of Times Observed (if recurring)
[ ] Date of Initial Observation
[ ] Supporting Documentation (e.g., logs, reports)
[ ] Investigation Team Lead

--- CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) ---
[ ] Detailed Description of Corrective Action
[ ] Detailed Description of Preventive Action
[ ] Estimated Cost of Corrective Action (USD)
[ ] Planned Implementation Date of Corrective Action
[ ] Planned Implementation Date of Preventive Action
[ ] Responsible Department for CAPA Implementation (Quality Assurance, Manufacturing, Engineering, Validation, Other)
[ ] CAPA Priority (High, Medium, Low)
[ ] Signature of Person Implementing CAPA

--- CAPA EFFECTIVENESS VERIFICATION ---
[ ] Verification Start Date
[ ] Verification Completion Date
[ ] Verification Outcome (Effective, Partially Effective, Ineffective)
[ ] Detailed Description of Verification Activities
[ ] Number of Instances of Deviation Since CAPA Implementation
[ ] Summary of Data Analyzed for Verification
[ ] Were there any unexpected findings during verification? (Yes, No)
[ ] If yes, describe unexpected findings

--- DOCUMENTATION & RECORD KEEPING ---
[ ] Deviation Description (Detailed)
[ ] Supporting Documentation (e.g., Batch Records, Lab Reports)
[ ] Date of Record Creation
[ ] Time of Record Creation
[ ] Document Control Number
[ ] Signature of Person Completing Record
[ ] Record Status (Draft/Reviewed/Approved/Closed) (Draft, Reviewed, Approved, Closed)

--- RISK ASSESSMENT & IMPACT ANALYSIS ---
[ ] Estimated Potential Impact Score (1-5)
[ ] Potential Impact Areas Affected (Product Quality, Patient Safety, Regulatory Compliance, Manufacturing Process, Data Integrity)
[ ] Description of Potential Risk
[ ] Probability of Recurrence (1-5)
[ ] Severity Assessment (Minor, Moderate, Major)
[ ] Justification for Risk Assessment

--- CLOSURE & REVIEW ---
[ ] Deviation Closure Date
[ ] Summary of Review Findings
[ ] Overall Risk Reassessment (Post-CAPA) (High, Medium, Low)
[ ] Recommendations for Process Improvement
[ ] Reviewer Signature
[ ] Reviewer Name
[ ] Revision Number

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