GOOD LABORATORY PRACTICE (GLP) CHECKLIST

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--- PERSONNEL & TRAINING ---
[ ] Number of Trained Personnel
[ ] Training Records Accessible? (Yes, No)
[ ] Last Training Refresher Date (Manufacturing Personnel)
[ ] Briefly describe the training program content (Manufacturing Personnel)
[ ] Training Topics Covered (Select all that apply) (SOPs, Safety Procedures, Equipment Operation, Data Integrity, GLP Principles, Quality Control)
[ ] Is there a documented training matrix? (Yes, No)
[ ] Description of procedures for addressing performance deficiencies identified during training or manufacturing.

--- FACILITIES & EQUIPMENT ---
[ ] Room Temperature (°C)
[ ] Humidity (%)
[ ] Cleaning Validation Status (Validated, Not Validated, Revalidation Needed)
[ ] Last Calibration Date - Critical Equipment (e.g., Balances, pH Meters)
[ ] Equipment Maintenance Schedule Adherence (Compliant, Minor Deviation, Major Deviation)
[ ] Description of Any Observed Environmental Issues (e.g., leaks, pests)
[ ] Calibration Certificates (Upload)
[ ] HVAC System Functionality (Fully Functional, Minor Issue, Major Issue)

--- MATERIALS MANAGEMENT ---
[ ] Batch Number Verification
[ ] Material Supplier Qualification Status (Approved, Pending Approval, Not Approved)
[ ] Date of Material Receipt
[ ] Material Receipt Comments (e.g., condition upon arrival)
[ ] Quantity Received (per unit)
[ ] Material Storage Condition (Controlled Temperature, Controlled Humidity, Ambient)
[ ] Storage Location Notes
[ ] Certificate of Analysis (CoA)
[ ] Quarantine Status (Quarantined, Released)

--- MANUFACTURING PROCEDURES (SOPS) ---
[ ] SOP Exists for Each Manufacturing Step?
[ ] Are SOPs Regularly Reviewed and Updated?
[ ] SOP Approval Process Defined? (Yes, No, Not Applicable)
[ ] SOP Revision Number
[ ] Date of Last SOP Review
[ ] Departments Involved in SOP Review/Approval (Manufacturing, Quality Assurance, Engineering, Regulatory Affairs)
[ ] Brief Description of SOP Change Control Process Related to Manufacturing Procedures

--- DOCUMENTATION & RECORD KEEPING ---
[ ] Batch Manufacturing Record (BMR) Completeness
[ ] Date of Record Creation
[ ] Time of Record Creation
[ ] Batch Number
[ ] Equipment Log Entries Description
[ ] Supporting Documents (e.g., Chromatograms, Test Results)
[ ] Record Review Status (Approved/Rejected) (Approved, Rejected)
[ ] Reviewer Signature
[ ] Corrections/Amendments Description (if any)
[ ] Date of Record Review

--- QUALITY CONTROL & TESTING ---
[ ] Batch Number Verified?
[ ] Analytical Method Used (per SOP)? (Method A, Method B, Method C, Other (Specify))
[ ] Analytical Results Summary (briefly describe)
[ ] Temperature during Testing (deg C)
[ ] Date of Testing
[ ] Tests Performed (check all that apply) (Appearance, Assay, Identity, Purity, Moisture Content, Other (Specify))
[ ] Attach Analytical Certificates/Reports

--- DEVIATIONS & INVESTIGATIONS ---
[ ] Date of Deviation
[ ] Time of Deviation
[ ] Detailed Description of Deviation
[ ] Root Cause Analysis (RCA)
[ ] Potential Contributing Factors (Equipment Failure, Human Error, Material Issue, Procedure Inadequacy, Other (Specify in LONG_TEXT))
[ ] Corrective Action Plan
[ ] Number of Batches Affected (if applicable)
[ ] Severity of Deviation (Minor, Moderate, Major)
[ ] Signature of Investigator
[ ] Date Corrective Action Implemented

--- CHANGE CONTROL ---
[ ] Description of Proposed Change
[ ] Reason for Change Request
[ ] Estimated Impact on Production Timeline (Days)
[ ] Affected Areas/Departments (Manufacturing, Quality Control, Engineering, Regulatory Affairs, Supply Chain)
[ ] Date of Change Request
[ ] Change Priority (High, Medium, Low) (High, Medium, Low)
[ ] Supporting Documentation (e.g., Drawings, Specifications)
[ ] Change Status (Submitted, In Review, Approved, Rejected, Implemented) (Submitted, In Review, Approved, Rejected, Implemented)
[ ] Requestor Signature

--- EQUIPMENT QUALIFICATION & VALIDATION ---
[ ] Date of Initial Qualification
[ ] Equipment Serial Number
[ ] Description of Qualification Activities Performed
[ ] Acceptance Criteria Threshold (e.g., Temperature Range)
[ ] Qualification Status (Passed, Failed, Pending, N/A)
[ ] Qualification Report (PDF/DOCX)
[ ] Date of Last Requalification/Verification
[ ] Details of any Deviations found during Qualification and Corrective Actions Taken
[ ] Equipment Type (Manufacturing Equipment, Cleaning Equipment, Analytical Equipment, Other)
[ ] Signature of Person Performing Qualification

--- PROCESS VALIDATION ---
[ ] Validation Plan Summary: Briefly describe the overall validation plan for the manufacturing process.
[ ] Number of Validation Batches: Specify the number of batches used for process validation.
[ ] Start Date of Validation Campaign: Record the commencement date of the validation process.
[ ] Completion Date of Validation Campaign: Document the end date of the validation process.
[ ] Acceptance Criteria for Critical Process Parameters (CPPs): Specify the acceptable range for each CPP.
[ ] Validation Status: Select the current validation status (e.g., Planned, In Progress, Completed, Failed). (Planned, In Progress, Completed, Failed)
[ ] Attachment: Raw data, validation reports, statistical analysis results
[ ] Summary of Validation Results & Conclusion: Detailed summary of the validation findings and the overall conclusion regarding process validation.
[ ] Validation Team Leader Signature

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