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.
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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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Select calibration status.
Select the date of last calibration.
Enter tolerance limits in relevant units.
Select maintenance status.
Select the compliance status regarding PPE usage.
Provide details if SDS are not available.
Select the status of emergency equipment.
Indicate if safety training has been completed.
Select the labeling compliance status.
Provide details about the storage locations.
Enter the maximum quantity in liters.
Select the status of secondary containment.
Select the labeling compliance status.
Provide details about the waste disposal procedures.
Enter the maximum accumulation time in days.
Select training status.
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
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