Good Laboratory Practice (GLP) Checklist

Ensure flawless manufacturing with our comprehensive Good Laboratory Practice (GLP) Checklist! Stay compliant, minimize risks, and boost product quality. Download your free checklist now & streamline your GLP adherence in manufacturing.

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Personnel & Training

1 of 10

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

2 of 10

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

3 of 10

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)

4 of 10

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

5 of 10

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

6 of 10

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

7 of 10

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

8 of 10

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

9 of 10

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

10 of 10

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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