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GLP Laboratory Equipment Validation Checklist

A comprehensive checklist for validating and maintaining laboratory equipment in compliance with GLP standards, covering all aspects of equipment qualification, calibration, and performance verification.

GLP Laboratory Equipment Validation Checklist
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About This Checklist

Ensuring the proper validation and maintenance of laboratory equipment is crucial for compliance with Good Laboratory Practice (GLP) standards in the pharmaceutical industry. This GLP Laboratory Equipment Validation Checklist is designed to guide laboratory managers, quality assurance personnel, and equipment specialists through the comprehensive process of validating and maintaining critical laboratory instruments. By implementing this checklist, pharmaceutical organizations can enhance the reliability of their analytical results, ensure data integrity, and maintain GLP compliance throughout their equipment lifecycle.

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Industry

Pharmaceuticals

Standard

Good Laboratory Practice (GLP)

Workspaces

Pharmaceutical Quality Control Laboratory

Occupations

Laboratory Manager
Equipment Validation Specialist
Quality Assurance Officer
Metrologist
Instrumentation Technician

Laboratory Equipment Validation

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1
Is the equipment compliant with data integrity standards?

Select the data integrity compliance status.

Data integrity compliance is essential for reliable and trustworthy results.
2
What is the performance verification score of the equipment?

Enter the performance verification score (0-100).

Performance verification scores indicate the reliability of the equipment's performance.
Min: 0
Target: 75
Max: 100
3
What is the date of the last validation performed on the equipment?

Enter the date of last validation (YYYY-MM-DD).

The validation date helps track the performance and compliance of the equipment.
4
Is the equipment calibrated according to the specified schedule?

Select the calibration status of the equipment.

Calibration ensures that the equipment provides accurate and reliable results.
5
Is the equipment in compliance with quality control procedures?

Select the quality control compliance status.

Compliance with quality control procedures is critical for ensuring reliable results.
6
What is the calibration interval for this equipment in months?

Enter the calibration interval in months.

Understanding the calibration interval helps in scheduling timely calibrations to ensure accuracy.
Min: 1
Target: 12
Max: 24
7
What is the date of the last calibration of the equipment?

Enter the last calibration date (YYYY-MM-DD).

Tracking calibration dates is essential for maintaining compliance and operational efficiency.
8
Is the equipment qualified for its intended use?

Select the qualification status of the equipment.

Qualification ensures that the equipment meets specific requirements before being put into operation.
9
Are the users of the equipment adequately trained?

Select the user training compliance status.

Training compliance is crucial for safe and effective equipment use.
10
How many hours has the equipment been used since its last calibration?

Enter the number of usage hours.

Tracking usage hours helps assess the need for recalibration based on the equipment's operational load.
Min: 0
Target: 100
Max: 10000
11
Please provide details of the last maintenance performed on the equipment.

Enter the maintenance details.

Detailed maintenance records help ensure compliance and traceability.
12
Is the equipment maintained according to the manufacturer's specifications?

Select the maintenance status of the equipment.

Proper maintenance is essential for optimal equipment performance and longevity.
13
Is all necessary documentation for the equipment available and accessible?

Select the documentation availability status.

Availability of documentation is vital for compliance and operational efficiency.
14
What is the maximum operating temperature specified for the equipment?

Enter the maximum operating temperature in degrees Celsius.

Ensuring the equipment operates within specified temperature limits is crucial for performance and safety.
Min: 0
Target: 60
Max: 100
15
Describe any incidents or deviations related to the equipment usage.

Provide incident report details.

Documenting incidents helps in identifying trends and areas for improvement.
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16
Is the equipment operated in accordance with the standard operating procedures (SOPs)?

Select the SOP compliance status.

Compliance with SOPs ensures that the equipment is used correctly and consistently.

FAQs

This checklist covers a wide range of laboratory equipment including analytical instruments, measuring devices, data acquisition systems, and storage units critical to GLP-compliant operations.

Initial validation should be performed before equipment use, with periodic revalidation based on equipment type, usage frequency, and manufacturer recommendations, typically ranging from 6 months to 2 years.

The checklist should be completed by qualified personnel such as laboratory managers, equipment specialists, or validation engineers, with oversight from quality assurance staff.

By ensuring thorough equipment validation and documentation, this checklist helps demonstrate GLP compliance during regulatory inspections and audits, providing evidence of proper equipment qualification and maintenance.

Yes, while maintaining core GLP principles, the checklist can be tailored to address specific validation requirements for different types of laboratory equipment and instruments.

Benefits

Ensures consistent and thorough equipment validation processes

Helps maintain GLP compliance for laboratory instrumentation

Reduces the risk of equipment-related data integrity issues

Facilitates efficient equipment qualification and requalification

Supports traceability and documentation of equipment performance