ABSTRACT

This chapter discusses the quality assurance and quality control applications are examined that govern regulated studies related to health and environmental effects of chemicals and pesticides. Good Laboratory and Clinical Practices guidelines used by the Environmental Protection Agency to assess product registration are reviewed in detail, including further discussion of the trends for future organization and control of scientific data. Scientific measurements in tests are often the basis for critical decisions regarding human health and protection of the environment. Quality assurance personnel must be involved in every critical phase of a study, including protocol preparation, application of the test substance, collection and analysis of samples, and verification of all raw data and final report. An important requirement of this subpart is that Standard operating procedures manuals be available to the personnel performing the testing and in close proximity to where the actual procedure or testing is performed.