PHARMACEUTICAL CHANGE CONTROL CHECKLIST

Created by ChecklistGuro (https://checklistguro.com)


--- INITIATION & SCOPE DEFINITION ---
[ ] Change Request Description
[ ] Change Category (Equipment, Process, Personnel, Documentation, Software)
[ ] Change Request Number
[ ] Request Date
[ ] Justification for Change
[ ] Affected Area/Department (Manufacturing, Quality Control, Engineering, Warehouse)

--- RISK ASSESSMENT ---
[ ] Describe the Potential Risk
[ ] Risk Severity Score (1-10)
[ ] Risk Probability Score (1-10)
[ ] Risk Category (Safety, Quality, Compliance, etc.) (Safety, Quality, Compliance, Efficiency, Cost)
[ ] Affected Areas/Systems (Manufacturing Process, Equipment, Documentation, Personnel, IT Systems)
[ ] Justification for Risk Scores

--- IMPACT ASSESSMENT ---
[ ] Describe the affected systems/processes.
[ ] Estimated Impact on Batch Cycle Time (hours)
[ ] Impact on Equipment Qualification? (Yes, No, Potentially)
[ ] Which departments are affected? (Manufacturing, Quality, Engineering, Regulatory, Warehouse)
[ ] Estimated Implementation Date
[ ] Potential Cost Impact ($)

--- CHANGE PLANNING & APPROVAL ---
[ ] Change Request Number
[ ] Change Description (Detailed)
[ ] Estimated Implementation Time (Hours)
[ ] Change Priority (High, Medium, Low)
[ ] Proposed Implementation Date
[ ] Approval Authority (Primary)
[ ] Primary Approver Signature

--- IMPLEMENTATION & EXECUTION ---
[ ] Planned Start Date
[ ] Planned Start Time
[ ] Detailed Implementation Steps
[ ] Quantity of Materials Used (if applicable)
[ ] Supporting Documentation (e.g., SOP deviations)
[ ] Implementation Method (e.g., Parallel, Phased, Big Bang) (Parallel, Phased, Big Bang)
[ ] Actual Start Date
[ ] Actual Start Time

--- VERIFICATION & VALIDATION ---
[ ] Batch Number Verified
[ ] Verification Status (Pass, Fail, Pending)
[ ] Verification Notes
[ ] Verification Date
[ ] Verification Signatory
[ ] Validation Test Results (Meets Specifications, Outside Specifications)

--- DOCUMENTATION & TRAINING ---
[ ] Updated SOP Summary
[ ] Affected SOPs (SOP-001, SOP-002, SOP-003, N/A)
[ ] Training Completion Deadline
[ ] Training Record Reviewer Signature
[ ] Number of Personnel Trained
[ ] Training Method (Classroom, Online, Self-Study)

--- CLOSURE & SIGN-OFF ---
[ ] Closure Date
[ ] Change Author Signature
[ ] Change Reviewer Signature
[ ] Summary of Change Outcome
[ ] Lessons Learned / Improvement Opportunities
[ ] Change Status (Closed, Cancelled, Deferred)

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