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

Is the temperature maintained within the specified range in the laboratory?

Select compliance status.

To ensure that the laboratory conditions are suitable for pharmaceutical research.

What is the current humidity level in the laboratory?

Enter the humidity level as a percentage.

To monitor environmental conditions critical for research integrity.

Min: 30

Target: 50

Max: 70

Is the air quality within acceptable limits in the laboratory?

Select compliance status.

To ensure the safety and efficacy of pharmaceutical research activities.

Are the environmental monitoring records up to date?

Provide details if records are not up to date.

To verify that all monitoring activities are documented and compliant with GLP standards.

Is the laboratory balance calibrated and within the acceptable calibration range?

Select calibration status.

To ensure accurate measurements are taken during pharmaceutical research.

When was the last calibration of the laboratory equipment performed?

Select the date of last calibration.

To ensure regular calibration schedules are followed as per GLP guidelines.

What are the calibration tolerance limits for the laboratory equipment?

Enter tolerance limits in relevant units.

To assess whether the equipment is operating within acceptable limits.

Min: 0.001

Target: 0.01

Max: 0.05

Is there a record of regular maintenance for the laboratory equipment?

Select maintenance status.

To ensure that all equipment is properly maintained and functioning optimally.

Is appropriate personal protective equipment being used by all laboratory personnel?

Select the compliance status regarding PPE usage.

To ensure the safety of personnel while working in the laboratory.

Are Safety Data Sheets available for all chemicals used in the laboratory?

Provide details if SDS are not available.

To ensure that all hazardous materials are properly documented and accessible.

Is emergency equipment (eyewash station, fire extinguisher) accessible and functional?

Select the status of emergency equipment.

To verify that emergency measures are in place and ready for use.

Have all laboratory personnel completed necessary safety training?

Indicate if safety training has been completed.

To ensure all staff are properly trained in safety protocols.

Safety Training Completed

Are all chemicals properly labeled according to regulatory standards?

Select the labeling compliance status.

To ensure that all chemicals are easily identifiable and safely stored.

Are chemicals stored in designated areas according to their hazard classifications?

Provide details about the storage locations.

To prevent accidents and ensure compliance with safety regulations.

What is the maximum quantity of hazardous chemicals stored in the laboratory?

Enter the maximum quantity in liters.

To ensure that storage limits are not exceeded, reducing the risk of incidents.

Min: 0

Target: 50

Max: 100

Is secondary containment available for all hazardous chemical storage?

Select the status of secondary containment.

To ensure that leaks or spills are contained to prevent environmental contamination.

Are all hazardous waste containers properly labeled?

Select the labeling compliance status.

To ensure safe handling and disposal of hazardous waste materials.

Are the waste disposal procedures documented and followed?

Provide details about the waste disposal procedures.

To verify adherence to regulatory requirements for waste management.

What is the maximum accumulation time for hazardous waste before disposal?

Enter the maximum accumulation time in days.

To ensure that waste is not stored longer than regulations allow.

Min: 0

Target: 90

Max: 180

Have all personnel received training on hazardous waste disposal procedures?

Select training status.

To ensure that all staff are knowledgeable about safe waste management practices.

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