Good Laboratory Practice (GLP) Checklist
Download our free GLP Checklist Excel template to ensure regulatory compliance, optimize lab workflows, and boost operational productivity with ChecklistGuro.
| Label | Value | Notes |
|---|---|---|
| Created by checklistguro.com | ||
| Personnel & Training (STEP) | ||
| Number of Trained Personnel (NUMBER) | ||
| Training Records Accessible? (SELECTION options: Yes, No) | ||
| Last Training Refresher Date (Manufacturing Personnel) (DATE) | ||
| Briefly describe the training program content (Manufacturing Personnel) (TEXT) | ||
| Training Topics Covered (Select all that apply) (SELECTION options: SOPs, Safety Procedures, Equipment Operation, Data Integrity, GLP Principles, Quality Control) | ||
| Is there a documented training matrix? (SELECTION options: Yes, No) | ||
| Description of procedures for addressing performance deficiencies identified during training or manufacturing. (TEXT) | ||
| Facilities & Equipment (STEP) | ||
| Room Temperature (°C) (NUMBER) | ||
| Humidity (%) (NUMBER) | ||
| Cleaning Validation Status (SELECTION options: Validated, Not Validated, Revalidation Needed) | ||
| Last Calibration Date - Critical Equipment (e.g., Balances, pH Meters) (DATE) | ||
| Equipment Maintenance Schedule Adherence (SELECTION options: Compliant, Minor Deviation, Major Deviation) | ||
| Description of Any Observed Environmental Issues (e.g., leaks, pests) (TEXT) | ||
| Calibration Certificates (Upload) (UPLOAD) | ||
| HVAC System Functionality (SELECTION options: Fully Functional, Minor Issue, Major Issue) | ||
| Materials Management (STEP) | ||
| Batch Number Verification (NUMBER) | ||
| Material Supplier Qualification Status (SELECTION options: Approved, Pending Approval, Not Approved) | ||
| Date of Material Receipt (DATE) | ||
| Material Receipt Comments (e.g., condition upon arrival) (TEXT) | ||
| Quantity Received (per unit) (NUMBER) | ||
| Material Storage Condition (SELECTION options: Controlled Temperature, Controlled Humidity, Ambient) | ||
| Storage Location Notes (TEXT) | ||
| Certificate of Analysis (CoA) (UPLOAD) | ||
| Quarantine Status (SELECTION options: Quarantined, Released) | ||
| Manufacturing Procedures (SOPs) (STEP) | ||
| SOP Exists for Each Manufacturing Step? (TEXT) | ||
| Are SOPs Regularly Reviewed and Updated? (UPLOAD) | ||
| SOP Approval Process Defined? (SELECTION options: Yes, No, Not Applicable) | ||
| SOP Revision Number (NUMBER) | ||
| Date of Last SOP Review (DATE) | ||
| Departments Involved in SOP Review/Approval (SELECTION options: Manufacturing, Quality Assurance, Engineering, Regulatory Affairs) | ||
| Brief Description of SOP Change Control Process Related to Manufacturing Procedures (TEXT) | ||
| Documentation & Record Keeping (STEP) | ||
| Batch Manufacturing Record (BMR) Completeness (TEXT) | ||
| Date of Record Creation (DATE) | ||
| Time of Record Creation (DATE) | ||
| Batch Number (NUMBER) | ||
| Equipment Log Entries Description (TEXT) | ||
| Supporting Documents (e.g., Chromatograms, Test Results) (UPLOAD) | ||
| Record Review Status (Approved/Rejected) (SELECTION options: Approved, Rejected) | ||
| Reviewer Signature (SIGNATURE) | ||
| Corrections/Amendments Description (if any) (TEXT) | ||
| Date of Record Review (DATE) | ||
| Quality Control & Testing (STEP) | ||
| Batch Number Verified? (NUMBER) | ||
| Analytical Method Used (per SOP)? (SELECTION options: Method A, Method B, Method C, Other (Specify)) | ||
| Analytical Results Summary (briefly describe) (TEXT) | ||
| Temperature during Testing (deg C) (NUMBER) | ||
| Date of Testing (DATE) | ||
| Tests Performed (check all that apply) (SELECTION options: Appearance, Assay, Identity, Purity, Moisture Content, Other (Specify)) | ||
| Attach Analytical Certificates/Reports (UPLOAD) | ||
| Deviations & Investigations (STEP) | ||
| Date of Deviation (DATE) | ||
| Time of Deviation (DATE) | ||
| Detailed Description of Deviation (TEXT) | ||
| Root Cause Analysis (RCA) (TEXT) | ||
| Potential Contributing Factors (SELECTION options: Equipment Failure, Human Error, Material Issue, Procedure Inadequacy, Other (Specify in LONG_TEXT)) | ||
| Corrective Action Plan (TEXT) | ||
| Number of Batches Affected (if applicable) (NUMBER) | ||
| Severity of Deviation (SELECTION options: Minor, Moderate, Major) | ||
| Signature of Investigator (SIGNATURE) | ||
| Date Corrective Action Implemented (DATE) | ||
| Change Control (STEP) | ||
| Description of Proposed Change (TEXT) | ||
| Reason for Change Request (TEXT) | ||
| Estimated Impact on Production Timeline (Days) (NUMBER) | ||
| Affected Areas/Departments (SELECTION options: Manufacturing, Quality Control, Engineering, Regulatory Affairs, Supply Chain) | ||
| Date of Change Request (DATE) | ||
| Change Priority (High, Medium, Low) (SELECTION options: High, Medium, Low) | ||
| Supporting Documentation (e.g., Drawings, Specifications) (UPLOAD) | ||
| Change Status (Submitted, In Review, Approved, Rejected, Implemented) (SELECTION options: Submitted, In Review, Approved, Rejected, Implemented) | ||
| Requestor Signature (SIGNATURE) | ||
| Equipment Qualification & Validation (STEP) | ||
| Date of Initial Qualification (DATE) | ||
| Equipment Serial Number (NUMBER) | ||
| Description of Qualification Activities Performed (TEXT) | ||
| Acceptance Criteria Threshold (e.g., Temperature Range) (NUMBER) | ||
| Qualification Status (SELECTION options: Passed, Failed, Pending, N/A) | ||
| Qualification Report (PDF/DOCX) (UPLOAD) | ||
| Date of Last Requalification/Verification (DATE) | ||
| Details of any Deviations found during Qualification and Corrective Actions Taken (TEXT) | ||
| Equipment Type (SELECTION options: Manufacturing Equipment, Cleaning Equipment, Analytical Equipment, Other) | ||
| Signature of Person Performing Qualification (SIGNATURE) | ||
| Process Validation (STEP) | ||
| Validation Plan Summary: Briefly describe the overall validation plan for the manufacturing process. (TEXT) | ||
| Number of Validation Batches: Specify the number of batches used for process validation. (NUMBER) | ||
| Start Date of Validation Campaign: Record the commencement date of the validation process. (DATE) | ||
| Completion Date of Validation Campaign: Document the end date of the validation process. (DATE) | ||
| Acceptance Criteria for Critical Process Parameters (CPPs): Specify the acceptable range for each CPP. (NUMBER) | ||
| Validation Status: Select the current validation status (e.g., Planned, In Progress, Completed, Failed). (SELECTION options: Planned, In Progress, Completed, Failed) | ||
| Attachment: Raw data, validation reports, statistical analysis results (UPLOAD) | ||
| Summary of Validation Results & Conclusion: Detailed summary of the validation findings and the overall conclusion regarding process validation. (TEXT) | ||
| Validation Team Leader Signature (SIGNATURE) |
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