The Environmental protection agency (EPA) issued the final rule on good laboratory practice standards that became effective on October 16, 1989. The standard is necessary for the testing in various areas of field studies, studies about the ecological effects, environmental fate and metabolism studies, and residue chemistry studies. All the studies have to be performed under EPA GLP standards which is also a requirement as per Product performance data requirements (40 CFR Part 158.640).<br/>EPA inspections are conducted by the GLP inspectors as a part of its GLP program where the compliance with the regulations is monitored and aids in assuring that studies submitted to the Agency in support of the pesticide registration were performed appropriately with maintaining the integrity and quality along with investigating to detect any violations. Where necessary, inspectors also collect evidence to prosecute FIFRA and TSCA violators by collecting samples and documentary evidence if any. The usual EPA GLP inspection starts from a general opening meeting with all stakeholders, a facility walk-through, requesting general facility-related records, SOPs, training records, instrument records, etc. Additionally, inspectors may like to inspect an in-life phase of ongoing study, a study archived which can be called a “model” or “representative” study, evaluate archive facility and effectiveness of the quality assurance unit, management of test, control, and reference substances along with their evidence.<br/>The presentation will detail the various stages during an inspection like an opening conference, the inspector may ask by questioning the test facility officials about practices, operations, and any other data that may require clarification or referring to the testing facility's organizational chart to learn who is in charge of what operations at the testing facility and whom to contact for additional information.

Auditing test facility as per EPA good laboratory practice standards: Regulatory insights

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