Good Laboratory Practice (GLP) Checklist
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Personnel & Training
Ensures qualified personnel are available and adequately trained for all manufacturing activities.
Number of Trained Personnel
Training Records Accessible?
Last Training Refresher Date (Manufacturing Personnel)
Briefly describe the training program content (Manufacturing Personnel)
Training Topics Covered (Select all that apply)
Is there a documented training matrix?
Description of procedures for addressing performance deficiencies identified during training or manufacturing.
Facilities & Equipment
Covers the suitability, maintenance, and calibration of facilities and equipment used in the manufacturing process.
Room Temperature (°C)
Humidity (%)
Cleaning Validation Status
Last Calibration Date - Critical Equipment (e.g., Balances, pH Meters)
Equipment Maintenance Schedule Adherence
Description of Any Observed Environmental Issues (e.g., leaks, pests)
Calibration Certificates (Upload)
HVAC System Functionality
Materials Management
Addresses the procurement, storage, handling, and traceability of raw materials, intermediates, and finished products.
Batch Number Verification
Material Supplier Qualification Status
Date of Material Receipt
Material Receipt Comments (e.g., condition upon arrival)
Quantity Received (per unit)
Material Storage Condition
Storage Location Notes
Certificate of Analysis (CoA)
Quarantine Status
Manufacturing Procedures (SOPs)
Focuses on documented procedures ensuring consistency and quality in the manufacturing process.
SOP Exists for Each Manufacturing Step?
Are SOPs Regularly Reviewed and Updated?
SOP Approval Process Defined?
SOP Revision Number
Date of Last SOP Review
Departments Involved in SOP Review/Approval
Brief Description of SOP Change Control Process Related to Manufacturing Procedures
Documentation & Record Keeping
Covers the proper recording, storage, and security of all manufacturing records.
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)
Reviewer Signature
Corrections/Amendments Description (if any)
Date of Record Review
Quality Control & Testing
Ensures adequate quality control procedures and testing are in place to verify product quality.
Batch Number Verified?
Analytical Method Used (per SOP)?
Analytical Results Summary (briefly describe)
Temperature during Testing (deg C)
Date of Testing
Tests Performed (check all that apply)
Attach Analytical Certificates/Reports
Deviations & Investigations
Addresses the process for identifying, documenting, investigating, and resolving deviations from established procedures.
Date of Deviation
Time of Deviation
Detailed Description of Deviation
Root Cause Analysis (RCA)
Potential Contributing Factors
Corrective Action Plan
Number of Batches Affected (if applicable)
Severity of Deviation
Signature of Investigator
Date Corrective Action Implemented
Change Control
Covers the process for managing and documenting changes to manufacturing processes, equipment, or materials.
Description of Proposed Change
Reason for Change Request
Estimated Impact on Production Timeline (Days)
Affected Areas/Departments
Date of Change Request
Change Priority (High, Medium, Low)
Supporting Documentation (e.g., Drawings, Specifications)
Change Status (Submitted, In Review, Approved, Rejected, Implemented)
Requestor Signature
Equipment Qualification & Validation
Verification and documentation that equipment and processes perform as expected.
Date of Initial Qualification
Equipment Serial Number
Description of Qualification Activities Performed
Acceptance Criteria Threshold (e.g., Temperature Range)
Qualification Status
Qualification Report (PDF/DOCX)
Date of Last Requalification/Verification
Details of any Deviations found during Qualification and Corrective Actions Taken
Equipment Type
Signature of Person Performing Qualification
Process Validation
Demonstration that a manufacturing process consistently produces products meeting predetermined specifications.
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).
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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