The Care & Feeding of an Environmental Monitoring System: Getting to GxP Compliance & Staying There - Industrial Controls

The Care & Feeding of an Environmental Monitoring System: Getting to GxP Compliance & Staying There

This article is brought to you by Vaisala.

When you install a new continuous monitoring system in a controlled environment you have made an important investment towards reducing several kinds of risk that your company is vulnerable to. First, you have reduced the risk of ruined or adulterated product by installing a monitoring system with alarm capability. Second, you have reduced the risk of lost or missing data by way of devices and software designed with redundant memory storage.

For the system to truly ensure compliance, it needs to be integrated into your firm’s Quality System. Not only must your software-based monitoring solution be integrated into your organization’s Quality System, its compliance with regulations published by the European Medicines Agency and the U.S. Food and Drug Administration must also be maintained.

Vaisala has put together this application note as a primer on how to maintain GxP compliance in your monitoring system over time.  The complete document can be downloaded on Vaisala’s website:  The Care & Feeding of an Environmental Monitoring: Getting to GxP Compliance & Staying There.  The primary areas where your monitoring system must be properly integrated and supported by your Quality System are outlined below.

SOPs

Standard Operating Procedures are keystone documents in any Quality System. These step-by-step instructions help ensure that processes perform as required by your operational goals. In addition, it is an overarching expectation in the life sciences that written procedures for GMP processes are established, followed and maintained under revision control.

To properly maintain your environmental monitoring system, you will rely on your SOPs for the operation and administration of both software and peripheral monitoring equipment. Ideally, there will already be dedicated SOPs within your Quality System governing other supporting activities such as Calibration, Training, Validation, and Change Control. If you don’t have SOPS for these activities, you can address these support activities (as they apply to your monitoring software only) in your monitoring system SOPs. All SOPs must be treated as controlled documents and provided with controls for approvals and revisions.

Training

It is another primary regulatory expectation that personnel are trained in the written procedures they are expected to perform. This applies to all systems employed in maintaining Good Manufacturing Practice. This makes sense because it is, after all, people who will be responsible for all activities in your Quality Control System; your firm’s compliance hinges on their knowledge of and adherence to established, documented procedures. Even in our world of automated processes, a human user is always going to either initiate, interact with, or oversee a process.

Every employee using an environmental monitoring system software must be trained according to the section(s) of the SOPs that apply to their job. Written records of the training should be maintained. Your organization must document who was trained, what the training consisted of, and who administered the training. The FDA provides a sample “Employee Training Record” as an exhibit in their “Postmarket Requirements (Medical Devices) article at “Device Advice: Comprehensive Regulatory Assistance.”

Validation

Processes that ensure quality in manufacturing are expected to be validated, especially when the process is automated, and this includes continuous monitoring systems designed for use in GxP environments. Basically, if a software is involved in a process that impacts the safety and purity of a drug or the efficacy of a device, it needs to be validated. To determine the scope of your validation efforts, a risk analysis saves both time and costs. Your monitoring software should be validated by its installation and operational qualification upon deployment. Changes in software versions, upgrades, updates, and patches or software upgrades will likely require re-validation. Your software manufacturer should be able to provide you with the necessary validation protocols to verify proper system operation following the installation of patches that are issued on your existing software.

Change Control

Any GMP process, automated or not, must be established with written procedures. When these procedures change, the FDA expects the change to be administered in a controlled fashion. This is generally known as “change control.” Any change to the system should be reviewed for impact prior to implementation. If necessary, additional validation testing may be required, depending on the nature of the changes.

Calibration

Monitoring systems, by nature, measure important environmental parameters such as temperature and humidity, using devices located in manufacturing, laboratory, and storage areas. There is an expectation from regulatory authorities that these devices provide accurate and reliable data. However, no sensor stays accurate forever. It is a basic expectation of the FDA that devices on your system be regularly calibrated to ensure accurate measurements and that records of the calibration events will be available for inspection. Depending on the sensor’s original accuracy as well as the demands of your application’s operating environment, calibration and functional testing of devices and metrological equipment is necessary, and mandated by EMA and the FDA.

Visit www.vaisala.com for application notes, infographics, animations and product information related to GxP compliance in your monitoring system.

Top

Leave a Reply

Required fields are marked *.


Top