Quality assurance aspects of an environmental fate study.
Environmental fate studies pose a challenge to the quality assurance officer due to the dynamic nature of the methodology. Protocols must be carefully constructed so that the study is conducted within GLP guidelines and is acceptable to the agency to which it is to be submitted. These protocols must also be flexible enough to adapt to methodologies that might evolve during the study. This flexibility requires careful auditing to assure adherence to the protocol and methods as they are developed. These ideas will be highlighted in a general discussion of the many aspects of environmental fate quality assurance.
Noland
M
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ABC Laboratories, Inc., Columbia, Missouri 65205.
D002985:Clinical Protocols; D004784:Environmental Monitoring / Q000592:standards*; D017408:Guidelines as Topic; D007753:Laboratories / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D014481:United States; D014484:United States Environmental Protection Agency; D014486:United States Food and Drug Administration