GOOD MANUFACTURING PRACTICES (GMP) CHECKLIST

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--- PERSONNEL & TRAINING ---
[ ] Number of Qualified Personnel
[ ] Training Records Maintained? (Yes, No, N/A)
[ ] Last GMP Training Completion Date (Employee 1)
[ ] Brief Description of Training Program Content
[ ] Personnel Hygiene Practices Observed? (Yes, No, N/A)
[ ] Personnel Training Records (Sample)
[ ] Specific Training Areas Covered (Select All That Apply) (Data Integrity, Equipment Operation, Personal Hygiene, Process Validation, Good Documentation Practices)
[ ] Name of Designated Training Coordinator

--- PREMISES & EQUIPMENT ---
[ ] Ambient Temperature (Manufacturing Area)
[ ] Relative Humidity (Manufacturing Area)
[ ] Description of any pest control measures taken
[ ] Floor Material Adequacy (Appropriate and Cleanable, Needs Improvement, Unacceptable)
[ ] Lighting Adequacy (Adequate for Operations, Insufficient, Needs Adjustment)
[ ] Photographs of Equipment and Facility
[ ] Last Equipment Cleaning Date
[ ] Description of any identified deficiencies

--- DOCUMENTATION & RECORDS ---
[ ] Document Creation Date
[ ] Document Revision Number
[ ] Document Purpose and Scope
[ ] SOP Document (e.g., Manufacturing Instructions)
[ ] Document Status (Approved/Reviewed/Obsolete) (Approved, Reviewed, Obsolete)
[ ] Document Review Date
[ ] Prepared By (Name & Position)
[ ] Signature of Document Author

--- RAW MATERIALS & COMPONENTS ---
[ ] Batch Number of Received Material
[ ] Date of Receipt
[ ] Supplier Approval Status (Approved, Pending Approval, Not Approved)
[ ] Quantity Received
[ ] Quantity Accepted
[ ] Remarks/Observations during Receipt
[ ] Certificate of Analysis (CoA) Received? (Yes, No)
[ ] CoA File Upload (if applicable)
[ ] Material Quarantine Status (Quarantined, Released)

--- MANUFACTURING PROCESS CONTROLS ---
[ ] Batch Size Confirmed?
[ ] Process Step Adherence (Fully Adhered, Minor Deviation, Significant Deviation)
[ ] Process Parameter Monitoring Details
[ ] Temperature During Reaction (ÂºC)
[ ] Reaction Completion Time
[ ] Any Process Anomalies Observed?
[ ] In-Process Testing Conducted? (Yes, No)
[ ] In-Process Testing Results (if applicable)

--- PACKAGING & LABELING ---
[ ] Packaging Material Approved? (Yes, No, N/A)
[ ] Packaging Material Specification Number:
[ ] Number of Packaging Components Verified:
[ ] Details of any discrepancies found in packaging:
[ ] Packaging Label Approval Document:
[ ] Label Information Verified against Master Record? (Yes, No, N/A)
[ ] Label Elements Verified (Check all that apply): (Product Name, Batch Number, Expiry Date, Dosage/Strength, Warnings, Storage Conditions, Manufacturer Information)
[ ] Label Sequence Number:

--- CLEANING & SANITATION ---
[ ] Cleaning Procedure Documentation
[ ] Cleaning Agents Used (Specify all) (Detergent, Sanitizer (Specify type: ________), Disinfectant (Specify type: ________), Other (Specify: ________))
[ ] Concentration of Cleaning Agents (%, ppm, etc.)
[ ] Date of Last Cleaning of Equipment/Area [Equipment ID/Area Name]
[ ] Details of any unusual cleaning procedures required for specific equipment/areas.
[ ] Cleaning Validation Status (For Critical Equipment/Processes) (Validated, Not Validated, Validation in Progress)
[ ] Attach Cleaning Logs for Recent Cleaning Cycle
[ ] Signature of Person Performing Cleaning Verification

--- MAINTENANCE & CALIBRATION ---
[ ] Last Calibration Date - Equipment X
[ ] Calibration Result - Equipment X
[ ] Tolerance Limit - Equipment X
[ ] Calibration Standard Used (NIST traceable, In-house Standard, Other (specify in LONG_TEXT))
[ ] Details of Calibration (if applicable)
[ ] Calibration Status (In Tolerance, Out of Tolerance, Requires Adjustment)
[ ] Calibration Certificate
[ ] Next Calibration Due Date - Equipment X

--- DEVIATIONS & CORRECTIVE ACTIONS ---
[ ] Detailed Description of Deviation
[ ] Date of Deviation Occurrence
[ ] Time of Deviation Occurrence
[ ] Quantity/Volume Affected (if applicable)
[ ] Severity Level (e.g., Minor, Major, Critical) (Minor, Major, Critical)
[ ] Root Cause Analysis - Detailed Explanation
[ ] Corrective Action Plan - Steps to be taken
[ ] Planned Completion Date of Corrective Action
[ ] Verification Method (How was effectiveness confirmed?) (Review of Records, Re-testing, Inspection, Other)
[ ] Signature of Person Implementing Corrective Action

--- CHANGE CONTROL ---
[ ] Description of Proposed Change
[ ] Rationale for Change (Justification)
[ ] Type of Change (Minor, Major, Technical, Personnel, Equipment)
[ ] Estimated Impact on Production (e.g., %)
[ ] Proposed Implementation Date
[ ] Supporting Documentation (e.g., Drawings, SOP revisions)
[ ] Affected Areas/Departments (Manufacturing, Quality Control, Engineering, Maintenance)
[ ] Risk Assessment Summary
[ ] Change Control Status (Proposed, Under Review, Approved, Rejected, Implemented)
[ ] Authorized Approver Signature

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