Test substance characterization for the EPA: what you've always wanted to know but were afraid to ask

The Society of Quality Assurance (SQA) GLP Specialty Section, a member of the SQA Regulatory Forum, is a group of participants from the regulated community which provides insight and guidance to our membership and the regulated community. The Specialty Section has encountered several participants who want to know what types of information and data are needed during an inspection by the US EPA's Office of Enforcement and Compliance Assurance (OECA). The OECA is responsible for monitoring studies submitted to the Office of Pesticide Programs in support of pesticide registrations as defined under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). All submitted studies are to be conducted according to the FIFRA US Good Laboratory Practice Standards (GLPS). The GLPS contain specific language concerning the characterization of test, control and reference substances used in these studies. This article clarifies those requirements and provides perspective on the EPA expectations on meeting those requirements. The topics of discussion include: regulatory requirements responsibilities of the testing facility management, study director, Quality Assurance Unit and the sponsor preparing for an inspection overview of data to be made available at the time of inspection composition of a Certificate of Analysis. Copyright © 2008 John Wiley & Sons, Ltd.