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(Last update was August 13, 1998)
The documents on the following pages
are related to Good Laboratory Practice (GLP) standards and quality
assurance or quality control for the federally regulated community.
A brief description of the GLP standards is presented after the document
list.
Comments and suggestions for additional documents to be added to
this list or links to existing documents are welcome. Contact me at
the address shown to the top left (below the Arch).
The Good Laboratory Practice standards (GLPs) are federal regulations
promulgated in the United States by both the Food
and Drug Administration in 21 CFR Part 58 and the Environmental
Protection Agency both for FIFRA in 40
CFR Part 160 and for TSCA in 40 CFR Part
792. In Japan, the Ministry for Agriculture,
Forestry and Fisheries (MAFF) has also adapted a version of the
GLP's.
The Good Laboratory Practice regulations describe the minimal standards
for conducting nonclinical laboratory studies that support or are intended
to support applications for research or marketing permits for products
regulated by FDA or EPA such as animal food additives, human and animal
drugs, medical devices for human use, biological products, electronic
products, or pesticide products. The regulations do not pertain to
studies utilizing human subjects or clinical studies for which the
current Good Clinical Practice (cGCP) standards would apply. Nor do
the GLPs pertain to basic exploratory studies carried out to determine
whether a test article has any potential utility or, for FDA studies
only, to determine physical or chemical characteristics of a test article.
In brief generalities and without being comprehensive, the following
practices must be adhered to for compliance with the standards:
A Sponsor is required to notify the testing facility that the study
must comply with the GLPs. Personnel records must be available to prove
adequate education, training and experience to enable the individual
to perform the assigned functions. Testing Facility Management must
be identified to designate or replace the Study Director, to assure
the presence of a Quality Assurance Unit, the characterization of test
and control articles, and to assure the presence of adequate personnel,
resources, facilities, equipment, materials, and methodologies. The
Study Director must be designated as the single source of study control
who assures that the protocol is approved and followed, that all experimental
data are recorded, that the GLPs are followed, and that all raw data,
documentation, protocols, specimens, and final reports are archived.
A Quality Assurance Unit must exist to assure management that facilities,
personnel, practices and records are in compliance with regulations,
to maintain a master schedule sheet of studies, to inspect each nonclinical
study at intervals to assure compliance and to report findings to Study
Director and Management, to review the final report to assure that
it accurately reflects the raw data, and to prepare and sign a QA statement
in the final report. Equipment shall have standard operating procedures
(SOPs) describing their use, maintenance, and calibration. All methods
shall have written standard operating procedures. Deviations from the
SOPs must be authorized by the Study Director. Each study shall have
a written Protocol describing the objectives and methods for the conduct
of the study. Data must be recorded in ink, dated and initialed. Changes
in data entries must be as specified. The final report shall contain
a compliance statement signed by the applicant, the sponsor and the
Study Director describing deviations, if any, from the GLP standards.
- Before initiating
a study requiring compliance with the Good Laboratory Practice standards
on the University of Georgia campus, please contact Dr.
Michael E. Mispagel, UGA's Quality Assurance Unit, at (706) 542-5729
to assist you in meeting these standards. Any comments regarding
this page or suggestions for additional links are welcome.
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