Good Laboratory Practice Standards (GLPs) are regulations (40 CFR Part 160) that prescribe good laboratory practices for conducting studies that support or are intended to support applications for research or marketing permits. GLP principles and guidance refers to a management quality system with quality controls in place to ensure production of data of known reliability, reproducibility, quality and integrity.
Stone is one of the few firms conducting pesticide registration studies with an in-house Quality Assurance Unit (QAU). Our clients don’t have to overextend their own QA staff or hire another vendor to obtain the QA services they need—we do it all under one roof. Not only does this save time, but it also showcases our commitment to data quality and GLP—a culture and commitment that permeates all of our agrochemical registration projects, as well as projects managed by Stone’s other services.
Our quality assurance manager ensures that GLP standards are met. We have corporate systems in place, managed by our QAU, for maintaining current standard operating procedures, staff training records, job descriptions, office and shop floor plans, and the study master schedule; for checking all data presentations for accuracy (QC); and for archiving study data. We have been audited by both EPA and our clients numerous times. The most recent EPA audit of our facility resulted in a letter of “no findings,” which is the most favorable opinion EPA can render. Our QAU is part of the team at Stone, helping to resolve day-to-day quality assurance issues, assisting project managers with regulatory compliance questions, assisting with study protocol interpretation and maintenance, and ensuring that Stone’s work products are the best they can be.
GLP Quality Assurance for FIFRA and FQPA
Stone has a thorough understanding of the Organization for Economic Cooperation and Development (OECD) and US GLPs and has been providing quality assurance oversight of EPA-regulated studies for several years. Stone has expertise in auditing analytical laboratories and testing facilities, and conducting field and onsite inspections. We also have provided protocol assessment, phase inspections, data and report audits, and training. In addition, we can help implement GLPs at your facility. Stone can provide QA for all GLP studies, including:
- Prospective groundwater
- Tap water (retrospective) groundwater
- Simulated rainfall runoff
- Community surface water monitoring
- Aquatic monitoring
- Terrestrial dissipation