title: Quality assurance responsibilities as defined by the EPA Good Automated Laboratory Practices (GALPs).
abstract: In December 1990, the Environmental Protection Agency's (EPA) Office of Information Resources Management (OIRM) issued a draft of the Good Automated Laboratory Practices (GALP). The GALPs developed from a union of existing Federal and EPA regulations and policies, including: the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) & Toxic Substance Control Act (TSCA), Good Laboratory Practices (GLP), the EPA Information Resources Management Policy (IRMP), and the Computer Security Act of 1987. The GALPs consolidate the regulations and policies to provide a single source of reference, and sever as an extension of the GLP standards (40 CFR 160 & 792). Whereas the GLPs describe acceptable laboratory management practices, the GALPs describe acceptable automated data management practices, and give guidance for standardizing and implementing procedures to ensure the quality and integrity of automated data collection and storage. The GALPs have been formatted to parallel the structure of the GLPs. Just as the GLPs define the responsibilities of the Quality Assurance Unit (QAU) in maintaining good laboratory practices, the GALPs define the responsibilities of the QAU in maintaining good automated data practices. The QAU is charged with (i) maintaining copies of written procedures for the automated data collection system, (ii) performing inspections of laboratory operations utilizing the automated data collection system and reporting findings, (iii) ensuring authorization and documentation of deviations from written procedures, (iv) auditing data and reports from the automated data collection system to ensure they accurately represent the raw data, and (v) maintaining records of the above-defined QAU functions.(ABSTRACT TRUNCATED AT 250 WORDS)
authors.affiliation: Xenobiotic Laboratories, Inc., Princeton, New Jersey 08543.
authors.forename: F G
authors.initials: FG
authors.lastname: Fielder
authors.forename: B A
authors.initials: BA
authors.lastname: Eleuteri
authors.forename: E M
authors.initials: EM
authors.lastname: Gross
mesh_terms: D002984:Clinical Laboratory Information Systems / Q000592:standards*; D017408:Guidelines as Topic; D007587:Job Description; D007753:Laboratories / Q000592:standards*; D011785:Quality Assurance, Health Care / Q000458:organization & administration*; D014481:United States; D014484:United States Environmental Protection Agency