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Related Experiment Videos

A procedure for assessing a contract testing facility: one sponsor's perspective

M M Twitty1, S A Martin, J L Henry

  • 1Dow Corning Corporation, Midland, MI 48686-0994, USA.

Quality Assurance (San Diego, Calif.)
|January 1, 1997
PubMed
Summary

Sponsors must ensure contract testing facilities comply with Good Laboratory Practices (GLP). A combined technical and compliance inspection, coupled with ongoing monitoring, effectively assesses and assures GLP compliance for submitted studies.

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Area of Science:

  • Regulatory compliance in scientific research
  • Pharmaceutical and chemical testing standards

Background:

  • Good Laboratory Practices (GLP) compliance is the sponsor's responsibility for submitted studies.
  • Initial assessment of testing facilities is crucial for regulatory compliance.
  • Traditional methods often conduct technical and compliance inspections separately.

Purpose of the Study:

  • To present a sponsor's collaborative approach for preliminary assessment of contract testing facilities.
  • To detail a method for assuring Good Laboratory Practices (GLP) compliance in outsourced studies.
  • To highlight the benefits of integrating initial assessments with ongoing performance monitoring.

Main Methods:

  • Literature review of inspection methodologies for testing facilities.

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  • Implementation of a collaborative approach combining technical and compliance evaluations.
  • Development of a program for actively monitoring the testing facility's study conduct performance.

    • Main Results:

    • The presented collaborative approach builds upon existing inspection methods.
    • Integrating initial assessments with continuous monitoring provides ongoing assurance.
    • This integrated approach benefits sponsors, testing facilities, and regulatory agencies.

    Conclusions:

    • A combined technical and compliance inspection, alongside continuous monitoring, is an effective strategy for ensuring GLP compliance.
    • This comprehensive assessment process helps sponsors meet their legal obligations.
    • The described methodology ensures the quality and integrity of studies conducted by contract testing facilities.