Enhance GLP with Environmental Monitoring

Improve data integrity and traceability with real-time monitoring

What is Good Laboratory Practice (GLP)?

Good Laboratory Practice (GLP) is a set of quality management controls that are intended to standardize the methods and conditions under which non-clinical research studies are designed and carried out, to ensure consistency, reproducibility, traceability and safety.

Standardized laboratory management procedures originally began to be introduced in the nineteen seventies. Although a number of smaller nations, such as New Zealand and Denmark, developed their own guidelines it was the intervention of America that played a crucial role in driving widespread international adoption of GLP procedures.

This was largely in response to concerns over the variability of laboratory research and reporting practices, culminating in a review of a major American research laboratory, Industrial Bio-Tech laboratories (IBT), where multiple examples of poor laboratory practices, scientific misconduct and falsification of toxicology test results were unearthed.

In 1978 the U.S. FDA (Food and Drug Administration) published its Guidance for Industry Good Practice Regulations. These guidelines were subsequently adopted on an international scale by the Organization for Economic Cooperation and Development (OECD) and by a Directive issued in 2004 by the European Union. Today, GLP is used by research laboratories around the world, providing a universally agreed baseline against which laboratory procedures and techniques are measured.

A failure in risk management procedures can also lead to the failure of an independent laboratory audit, carried out for example under the remit of GLP.

Failing an audit can also have serious consequences. It can result in loss of work and revenue, undermine reputation, waste time and divert staff resources and, in the worst-case scenario result in fines or prosecution. The challenge today is to ensure that each laboratory complies with its regulatory requirements, during a period when staff shortages and funding cuts are reducing the time and resources available to maintain regular and appropriate environmental monitoring and control procedures.

What are the requirements of Good Laboratory Practice (GLP)?

Good Laboratory Practice regulates the way in which research studies should be carried out and the quality controls that should be followed. As an example, this typically includes:

• Definition of the management responsibilities of the commissioning, research and quality control bodies.
• Documented operating procedures.
• Specification of laboratory facilities, to ensure that they are able to meet the study criteria.
• Definition of appropriate test and control equipment and instruments, including their calibration and maintenance.
• Definition of staff training and qualifications.
• The processes by which data is acquired, processed, archived and reported.

Real-time monitoring is key to effective GLP

One of the key elements for successfully managing GLP is the integrity and quality of laboratory data. This includes the data gathered from each experiment or research project and, as importantly, the data collected from laboratory equipment and instruments; this is essential to confirm that each is operating accurately and within specification.

There is little point in gathering research data if its integrity is going be adversely affected by, for example, a temperature-controlled storage unit that has drifted out of specification and damaged the quality of research specimens.

It is not uncommon for operational data from laboratory equipment to be collected at regular intervals, usually by a member of staff carrying our manual checks. Ignoring the fact that this approach can waste a considerable amount of staff time – especially if you add this up over a year – there are two inherent risks with manual processes: the potential for human error and delays in identifying possible problems with laboratory equipment, often until it is too late to take remedial action.

A far better solution is to use a real-time laboratory monitoring system. This simple, cost-effective solution is designed to measure continuously the operation of critical laboratory equipment, such as fridges, cryogenic freezers and autoclaves. Data is gathered, analyzed and stored either locally or in the cloud, and can easily be integrated into existing GLP processes, providing an extra depth of data that is crucial for GLP reporting and traceability, with accreditation to EU Annex 11 and FDA CFR 21 Part 11.

To learn more about our modular real-time laboratory monitoring system (RMS)

Author:
James Pickering, Director of Environmental Monitoring Systems

External Links

U.S. FDA GLP Regulations 1979

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