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.
I am the GLP Study Manager at RPS’ Bedford laboratory, and I act as a Study Director for GLP residues studies. I also manage the equipment and processes that are used for GLP purposes, ensuring that these are tested, calibrated and/or validated.
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.
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.
I joined RPS in March 2022 and, as with any new job, having to adapt to new ways of working and environment is always a challenge. This was especially true for me, since I was established at my previous job for over a decade. However, the people at RPS have been very welcoming and patient whenever I have a question.
My colleagues are friendly, and we manage to have a good laugh every day. The senior management team here are incredibly supportive and trusting in me which is what I appreciate the most.
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.
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.
We use an Orbitrap (high-resolution mass spectrometer) for our GLP analyses, which provides accurate mass data that traditional triple-quad (LC-MS/MS) instruments do not offer.
RPS has a logistics team covering many countries and continents. Furthermore, to ensure integrity of samples in transit, we supply dataloggers for all GLP sample shipments.
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