Good Laboratory Practice (GLP) Checklist

GOOD LABORATORY PRACTICE (GLP) CHECKLIST Created by ChecklistGuro (https://checklistguro.com) --- 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 --- END OF TEMPLATE --- Transform this text into a digital, automated, and trackable mobile app! 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