GLP or Good Laboratory Practice is something we at ELPRO LEPENIK place great importance on, as it is based on the integrity and quality of laboratory data, which is the guiding principle of our activities - in this area we offer Rotronic solutions for real-time monitoring.
Improve data integrity and traceability in the laboratory with real-time monitoring
Ensure that each laboratory meets its regulatory requirements in a period when staff shortages and funding cuts reduce the time and resources available to maintain regular and adequate environmental monitoring and control procedures.
Using a real-time laboratory monitoring system.
A simple, cost-effective solution designed to continuously measure the performance of critical laboratory equipment such as refrigerators, cryogenic freezers and autoclaves.
Good Laboratory Practice (GLP) is a set of quality management controls. It aims to standardise the methods and conditions under which non-clinical research studies are designed and conducted. It ensures consistency, reproducibility, traceability and security.
Standardised laboratory management procedures were originally introduced in the 1970s. centuries.
Although a number of smaller countries, such as New Zealand and Denmark, have developed their own guidelines, American intervention has played a key role in promoting wide international acceptance of the procedures.
This was largely in response to concerns about the variability of laboratory research and reporting practices. The highlight was an inspection of a major US research laboratory, Industrial Bio-Tech Laboratories (IBT), where numerous cases of poor laboratory practices, scientific misconduct and falsification of toxicology test results were uncovered.
In 1978, the US Food and Drug Administration (FDA) published its guidelines for Good Manufacturing Practice (GMP) regulations. These guidelines were subsequently adopted internationally by the Organisation for Economic Co-operation and Development (OECD) and in 2004 by a directive issued by the European Union.
Today, GLP is used by research laboratories all over the world. This provides them with the basic conditions under which laboratory procedures and techniques are carried out.
A failure in risk management procedures can also lead to the failure of an independent laboratory assessment, for example carried out under the responsibility of GLP.
A failed audit can have serious consequences such as loss of work and revenue, loss of reputation, loss of time, diversion of staff resources and, in the worst cases, fines or prosecution.
Today’s challenge is to ensure that each laboratory meets its regulatory requirements in a period when staff shortages and funding cuts are reducing the time and resources available to maintain regular and adequate environmental monitoring and control procedures.
Good laboratory practice governs the way in which research studies are carried out and the quality controls that must be followed.
This usually includes:
One of the key elements for the successful management of good laboratory practice is the integrity and quality of laboratory data. This includes data collected from each experiment or research project. Most importantly, it includes data collected from laboratory equipment and instruments. These are essential to confirm that each is working accurately and within specification.
There is no point in collecting research data if the integrity of the data will be adversely affected by, for example, a temperature-controlled storage unit that deviates from specifications and compromises the quality of the research samples.
It is not uncommon for data on the performance of laboratory equipment to be collected at regular intervals, usually by a member of staff carrying out manual checks.
Ignoring the fact that this approach can waste a lot of staff time – especially when added up over a year – there are two closely linked dangers of manual processes:
A much better solution is to use a real-time laboratory monitoring system.
This simple, cost-effective solution is designed to continuously measure the performance of critical laboratory equipment such as refrigerators, cryogenic freezers and autoclaves.
Data is collected, analysed and stored locally or in the cloud and can be easily integrated into existing GLP processes, providing additional data depth. They are key to GLP reporting and traceability, with accreditation under EU Annex 11 and FDA CFR 21 Part 11.
Strict requirements for environmental monitoring are laid down in codes of practice and guidance documents from various professional bodies to improve working practices and safety in laboratories.
PST-branded ambient monitoring solutions can help ensure real-time compliance with, among other things:
Ensuring patient safety and the highest quality care.
Monitoring of all environmental parameters to ensure the highest quality testing.
Compliance with regulations
Full data integrity and alarming to prevent product loss.
One solution for all locations
Access and monitor data from multiple branches at any time.
Saving time and improving working practices.
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They are always available for opinions and explanations:
Rotronic product expert Rok Samec
Measurement expert Zoran Lepenik
Mojca Kugler, Source: Enhance GLP with Environmental Monitoring? PST group, 2023