Managing GxP Compliance in Pharmaceutical Settings


For laboratory and pharmaceutical facilities, complying with GxP guidelines is crucial. In this article, learn the basics of GxP compliance, and discover how to leverage automated tools and technologies to make compliance simple.

GxP compliance is a means to demonstrate good practices that ensure safety in food, medical and even cosmetic products. The guidelines can be applied to a wide variety of activities including Good Laboratory Practices, Good Clinical Practices, and other GxP-regulated environments.

While the standards and regulations can be tailored to a particular field, they are centered on two main principles: accountability and traceability. In this article, we’ll look at GxP compliance in the context of the pharmaceutical industry and highlight solutions to help you meet best practice guidelines.

Understanding GxP in the Pharmaceutical Industry

Depending on the activities of your facility, you may find it necessary to meet a variety of guidelines such as Good Manufacturing Practice, which is focused on the quality and control of medications, medical devices, or active pharmaceutical ingredients. In clinical trial settings, Good Clinical Practices define the regulations for pharmaceutical testing with trial subjects. Good Laboratory Practices set standards for testing the safety and effectiveness of products.

The standards and regulations that define GxP focus on the parties involved in the creation of a product and when they participated; they also concern the ability to trace a product through the production process. These principles are centered on two main aspects of GxP compliance, including:

  • Traceability: ability to trace the entirety of a product’s creation.
  • Accountability: ability to demonstrate all contributors to a product’s creation.

In the pharmaceutical industry, GxP regulations are intended to address the safety of medical products and medications. The requirements are set by both national and international organizations, such as the Food and Drug Administration, and encompass several fields including manufacturing, clinical, laboratory, storage, distribution, and review.

Comprehensive GxP Compliance Solutions

Given the complexity of regulatory standards, it may feel like compliance is an enormous undertaking. However, GxP guidance is extremely structured and standards are aligned across different pharmaceutical activities. Many core best practices hold similar operational requirements that can be implemented through a methodical approach to facility controls and monitoring systems.

For example, Good Manufacturing Practices for Finished Pharmaceuticals require drug products to be stored in proper conditions of temperature, humidity, and light. This same requirement also applies to Good Clinical Practice standards. From a facility operations perspective, GxP compliance can be supported through a robust environmental monitoring system, such as Primex OneVue Sense — which offers superior temperature and humidity monitoring.

GxP Environment Best Practices

Environmental Monitoring and Storage Access Documentation

Meeting GxP compliance in pharmaceutical settings is heavily dependent on the ability of a facility to control and monitor environmental conditions. It also requires thorough documentation of conditions, access, duration of storage, and handling of medical products.

Primex OneVue Sense provides a solution that can help monitor environmental conditions with temperature, humidity, and contact closure sensors. The portable sensors are easily installed and can alert staff to temperature variances, log times of access to restricted areas, and capture the monitoring data for on-demand reporting through the OneVue Monitor dashboard.

Automated Environmental Monitoring for GxP Compliance

With a focus on accountability and traceability, GxP regulations demand the ability to track personnel activities and environmental conditions with precision. The Primex OneVue suite provides comprehensive solutions that allow your facility to monitor the temperature and humidity of, and access to, medical products and medications throughout manufacturing, laboratory, and healthcare settings.

The system eliminates the need to manually record data and allows you to demonstrate compliance with readily available reporting. You can maintain the integrity of controlled areas and verify your data is safely stored in a GxP compliant environment.

Meeting GxP Compliance with Primex OneVue

With Primex OneVue, maintaining and demonstrating GxP compliance can be done accurately through precision monitoring and thorough documentation. The OneVue suite of environmental monitoring solutions works seamlessly with the OneVue Monitor software to produce accurate compliance records.

Take control of GxP compliance with the help of Primex OneVue. Learn more by scheduling a consultation today!

References:

FDA Good Clinical Practice Regulations

FDA Good Laboratory Practice Regulations

International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)



Close