Amendments, nonclinical laboratory study

The FDA established a GLP review task team to identify provisions in the regulations that could be amended or deleted, and this team recommended revisions to 36 GLP provisions. Recommendations were issued as a proposed rule on October 29, 1984 [15]. The proposal made various changes to definitions to reduce the amount of paperwork required for nonclinical laboratory studies and to clarify earlier GLP provisions. Similar clarifications were made to the provisions, delineating the definition and function of the study director and quality assurance unit. 

The FDA has required a conforming amendments statement for all nonclinical laboratory studies submitted to FDA after June 20,1979, the effective date of the GLP regulations. A conforming amendments statement was thus required for studies completed prior to June 20, 1979, if the results of the studies were submitted to FDA after that date. 

When several nonclinical laboratory studies are contained in a single submission to FDA, a single conforming amendments statement may be included with the submission, or the sponsor may elect to prepare individual statements for each study. 

U.S. Food and Drug Administration (FDA), Good Laboratory Practice for Nonclinical Laboratory Studies Amendment of Good Laboratory Practice Regulations. Amendment, Federal Register, 1980 45, 24865. 

The final report and any amendments, all raw data, documentation, protocols and any amendments, and specimens (with the exception of specimens subject to degradation) generated as a result of a nonclinical laboratory study shall be retained in an archive. The archive facility needs to be set up for orderly storage and expedient retrieval. Conditions of storage shall minimize deterioration of the documents or specimens. The archives do not necessarily have to be an in-house facility the laboratory may contract with commercial archives to store materials in a GLP fashion. 

The definition of sponsor indicates who bears ultimate responsibility for a nonclinical laboratory study. A sponsor may assign the job of actual study conduct and/or reporting, but ultimate responsibility for the study cannot be delegated. The sponsor must thus assure that a nonclinical laboratory study is conducted in compliance with GLP standards, and must supply the statement of GLP compliance or description of GLP noncompliance (conforming amendments statement) that must accompany the submission to the FDA of the results of a nonclinical laboratory study (Section XI). The definition does not preclude joint sponsorship of a study. 

At the time of Federal Register publication of final GLP regulations, the FDA also made amendments to a multitude of other sections of 21 CFR. These so-called conforming amendments all require that a statement be included with respect to each nonclinical laboratory study submitted to the FDA in support of an application for a research or marketing permit. The conforming amendment statement can be in either of two forms. 

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