Introducing our GLP Study Manager, Grace Lau
Grace joined RPS in March 2022, we recently caught up with her to find out how she's found her first year with RPS, talking us through her role and to understand more about our Good Laboratory Practice (GLP) Services.
27 March 2023 | 4 min read
Why is GLP important for laboratories?
As a Study Director for GLP studies, I have the overall responsibility for the scientific conduct of the study, to ensure compliance with the OECD principles of GLP. Apart from checking that all required procedures are adhered to and that data is accurately recorded, the most important role of the Study Director is to make decisions when unexpected events occur. This is based on scientific data and experience, to assess impact and take corrective actions.
Can you define GLP and explain when GLP analysis is required?
GLP (Good Laboratory Practice) is a set of principles developed by the OECD as a regulatory control mechanism. These principles ensure the quality and integrity of non-clinical environmental health and safety studies. They were developed in response to fraudulent scientific data found in the 1970’s.
As a regulatory control mechanism, GLP compliance is written into law in many countries. There may be a legal requirement for non-clinical health and environmental safety studies to be conducted under GLP.
GLP applies to studies that are intended for submission to regulatory authorities in support of the registration, licensing, or regulation of chemical and related products. Studies conducted to GLP provide regulatory authorities the assurance of the quality and integrity of test data, in order to make valid regulatory risk assessment decisions.
How does GLP differ from our ISO 17025 accreditation?
Although both GLP and ISO 17025 set out requirements for quality management systems under which testing is conducted, they have different purposes.
Unlike GLP, which was developed by the regulatory sector, ISO 17025 was developed by the testing/calibration laboratory and accreditation communities. This international standard focusses on the operation and management of the laboratory, and on its capacity to produce consistent and reliable results that are scientifically valid. Assays are typically conducted on a regular basis according to defined methodology and performed as individual batches of tests, from day to day.
On the other hand, non-clinical health, and environmental safety testing is regulated and required to be conducted under GLP, and is often scientifically multi-disciplinary and largely variable in nature. The focus of GLP is the conduct of each individual study, which may be an experiment or a set of experiments, with a collection of different tests. These may run over the course of a few weeks or several years and possibly at multiple locations.
Therefore, GLP has very specific requirements that have been designed to accommodate the management of such variability to provide study data that can be relied upon for quality and scientific integrity.
How does the GLP team at RPS help our clients?
RPS has extensive expertise in testing for residues of pesticides, herbicides, fungicides, and other organic compounds. Our GLP team have many years of experience in the agrochemical industry, giving us the capability to manage a wide range of residues studies from the field phase through to analytical testing. Our GLP testing supports our clients to meet data requirements for the registration of their formulated products or active substances.
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