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GLP Facility and Environmental Conditions Audit Checklist

A comprehensive checklist for auditing facility infrastructure and environmental conditions in GLP-regulated pharmaceutical research environments, ensuring compliance with GLP standards and maintaining optimal research conditions.

GLP Facility and Environmental Conditions Audit Checklist

by: audit-now
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About This Checklist

Maintaining appropriate facility conditions and environmental controls is essential for ensuring the integrity of research conducted under Good Laboratory Practice (GLP) standards in the pharmaceutical industry. This GLP Facility and Environmental Conditions Audit Checklist is designed to help facility managers, quality assurance personnel, and environmental monitoring specialists evaluate and improve the physical infrastructure and environmental parameters critical to GLP compliance. By implementing this checklist, pharmaceutical organizations can ensure their research environments meet regulatory requirements, minimize external variables that could impact study results, and maintain the highest standards of research quality and data integrity.

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Industry

Healthcare

Standard

GLP - Good Laboratory Practice

Workspaces

Pharmaceutical Research Facilities

Occupations

Facility Manager
Environmental Monitoring Specialist
Quality Assurance Officer
GLP Compliance Manager
Laboratory Safety Coordinator
1
Is the temperature maintained within the specified range in the laboratory?
2
What is the current humidity level in the laboratory?
Min: 30
Target: 50
Max: 70
3
Is the air quality within acceptable limits in the laboratory?
4
Are the environmental monitoring records up to date?
5
Is the laboratory balance calibrated and within the acceptable calibration range?
6
When was the last calibration of the laboratory equipment performed?
7
What are the calibration tolerance limits for the laboratory equipment?
Min: 0.001
Target: 0.01
Max: 0.05
8
Is there a record of regular maintenance for the laboratory equipment?
9
Is appropriate personal protective equipment being used by all laboratory personnel?
10
Are Safety Data Sheets available for all chemicals used in the laboratory?
11
Is emergency equipment (eyewash station, fire extinguisher) accessible and functional?
12
Have all laboratory personnel completed necessary safety training?
13
Are all chemicals properly labeled according to regulatory standards?
14
Are chemicals stored in designated areas according to their hazard classifications?
15
What is the maximum quantity of hazardous chemicals stored in the laboratory?
Min: 0
Target: 50
Max: 100
16
Is secondary containment available for all hazardous chemical storage?
17
Are all hazardous waste containers properly labeled?
18
Are the waste disposal procedures documented and followed?
19
What is the maximum accumulation time for hazardous waste before disposal?
Min: 0
Target: 90
Max: 180
20
Have all personnel received training on hazardous waste disposal procedures?

FAQs

The checklist covers areas such as facility design and layout, air quality and ventilation systems, temperature and humidity control, lighting conditions, pest control measures, cleaning and sanitation procedures, and environmental monitoring systems.

Comprehensive audits should be conducted at least annually, with more frequent monitoring of critical parameters (e.g., temperature, humidity) on a daily or weekly basis as part of routine operations.

The audit should involve a team including facility managers, quality assurance personnel, environmental monitoring specialists, and representatives from relevant research departments to ensure a thorough assessment.

By ensuring optimal facility conditions and environmental controls, this checklist helps maintain a stable and controlled research environment, reducing variables that could impact study results and enhancing the overall reliability of GLP studies.

Yes, while maintaining core GLP principles, the checklist can be tailored to address specific requirements for different types of research facilities, such as animal testing facilities, analytical laboratories, or stability testing chambers.

Benefits of GLP Facility and Environmental Conditions Audit Checklist

Ensures compliance with GLP regulations for facility and environmental conditions

Minimizes the risk of environmental factors affecting study outcomes

Improves the reliability and reproducibility of research data

Facilitates early detection of potential facility-related issues

Supports a holistic approach to maintaining GLP-compliant research environments