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Related Experiment Videos

Environmental monitoring programs vs Good Laboratory Practice (GLP) programs: differences and similarities

R E Bentley1

  • 1Bentley & Associates, Middleboro, MA 02346, USA.

Quality Assurance (San Diego, Calif.)
|December 1, 1995
PubMed
Summary

Environmental monitoring and Good Laboratory Practice (GLP) programs share quality goals but differ operationally. GLP focuses on federal agencies, while environmental monitoring involves complex state-level regulations and certifications.

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Area of Science:

  • Environmental Science and Regulatory Compliance
  • Laboratory Quality Management Systems

Background:

  • Empirical similarities exist between Environmental Monitoring (EM) and Good Laboratory Practice (GLP) programs, particularly in quality assurance, safety, and procedural standardization.
  • Operational differences are significant, with GLP primarily governed by federal agencies like the Environmental Protection Agency (EPA) and Food and Drug Administration (FDA) without state resource involvement.

Purpose of the Study:

  • To delineate the operational distinctions between EM and GLP programs.
  • To highlight the complexities and challenges within state-operated EM programs.
  • To underscore the impetus for a national certification program in environmental monitoring.

Main Methods:

  • Comparative analysis of EM and GLP program structures and regulatory frameworks.

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  • Examination of federal and state legislative mandates influencing EM testing.
  • Review of certification requirements and operational costs for EM laboratories.

    • Main Results:

    • EM programs are governed by extensive federal legislation (e.g., CERCLA, RCRA, CWA, CAA, SDWA, NPDES) often requiring specific, statutorily mandated analytical procedures.
    • State governments operate many EM programs, necessitating multiple, often costly and conflicting, state-specific certifications for laboratories.
    • GLP programs are objective-driven, with procedures defined in study plans and protocols, and are administered federally.

    Conclusions:

    • The operational divergence between EM and GLP programs stems from differing regulatory scopes and administrative levels.
    • The fragmented and costly state-based certification system for EM laboratories presents significant challenges.
    • These challenges associated with state-operated programs are driving the demand for a unified national certification program.