Role of Good Experimental Practice (GEP) in Ensuring Environmental Safety
Discover how the Good Experimental Practice (GEP) quality system, implemented in the European Union since the 1990s, plays a crucial role in ensuring the reliability and safety of field experiments on pesticides used in crop production. Learn about the history, requirements, and contributions of the GEP system towards environmental safety, including efficacy assessment, dosage demonstration, prevention of side effects, and improved communication with regulatory authorities.
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Presentation Transcript
THE QUALITY SYSTEM OF GOOD EXPERIMENTAL PRACTICE (GEP) AND ITS ROLE IN ENVIRONMENTAL SAFETY Ewa Matyjaszczyk Bydgoszcz University of Science and Technology
Good Experimental Practice (GEP) Quality system used in the European Union Introduction 1990s Aim: to ensure the reliability of field experiments on pesticides used in crop production (plant protection products)
Good Experimental Practice (GEP) Abbreviated history of GEP system implementation Overview of its requirements. The focus of the paper is on the role of GEP system in proper recommendations for use of plant protection products, that further translate into ensuring environmental safety in the European Union.
How GEP system contributes to the environmental safety? 1) Focused on efficacy assessment / by suitable study design it prevents products that are ineffective from entering the market. 2) Focused on demonstrating suitable dosage of PPP for each use. 3) Focused on unwanted side effects. Following the rules of GEP if efficacy trials show unwanted side effects special trial may need to be performed. 4) Ensures that any results and observations relevant to environmental safety are recorded. 5) Contributes to making trial protocols uniform. Prevents from redundant effort, contributes to improved communication, saving time and resources. 6) Improves communication between GEP units and regulatory authorities (in both directions) that is essential for saving time and workload
