Good Laboratory Practice (GLP) as a Part of Innovation Processes
Good Laboratory Practice (GLP) is a set of principles intended to ensure the quality and integrity of non-clinical laboratory studies, which are crucial for the development of new medicines. By adhering to GLP standards, laboratories can produce reliable and reproducible data, which is essential for regulatory approval and subsequent clinical trials. Incorporating GLP into innovation processes in medicine enhances the credibility of research findings and accelerates the development of safe and effective medical treatments. Ultimately, GLP fosters trust and transparency in the medical innovation pipeline, benefiting both researchers and patients.
Good Laboratory Practice (GLP) is a quality system that ensures that non-clinical health and environmental safety studies are planned, conducted, monitored, recorded, archived, and reported consistently and transparently. It arose in response to failures and fraud in laboratories in the 1970s and today rests on internationally recognized OECD principles. It is the key to trustworthy data and accelerates innovation from the initial experiment through to regulatory approval. According to the OECD, GLP sets out how all steps of non-clinical safety studies should proceed—from planning through execution to archiving and data management—and also requires the formal reporting of errors. The impetus for its introduction was a series of deficiencies uncovered in the 1970s, including uncalibrated instruments, inappropriate test systems, and even falsified data. This was followed by the first systematic inspections and, over time, the adoption of harmonized OECD principles respected by regulators across countries. The goal is to generate reliable data for regulatory dossiers for medicines, pesticides, cosmetics, or industrial chemicals.What GLP is and why it was created
