Proposed GLP regulation

Like the FDA, the EPA determined that the promulgation of GLP regulations would most effectively handle the problem of compliance with adequate control standards, and the agency published proposed health effects standards for testing under TSCA on May 9, 1979 (11). Proposed GLP regulations applicable to laboratory studies submitted to the EPA in compliance with FIFRA were published on April 18, 1980... 

The purpose of the GLP regulations is to assure the quality and integrity of the data submitted to the FDA in support of the safety of regulated products. To this end, most of the requirements of the proposal would have been considered familiar and reasonable by any conscientious scientist. Protocols and standard operating procedures (SOPs), adequate facilities and equipment, full identification of test substances, proper animal care, equipment maintenance, accurate recording of observations, and accurate reporting of results are... 

The EPA s FIFRA and TSCA GLP regulations were both issued in final form on November 29, 1983 [14]. The FIFRA GLP regulations were codified as 40 CFR 160, and the TSCA GLP regulations as 40 CFR 792. In terms of the TSCA GLPs, the final regulations incorporated the proposed GLPs issued on May 9, 1979 and November 21, 1980. 

In 1984, the FDA proposed revising its 1978 GLP regulations. The rationale for this revision was to clarify, amend, or delete... 

Proposed good laboratory practice (GLP) regulations were published in 1976 [1]. Final regulations were published in 1978 [2], The regulations were revised in 1980 [3] and 1987 [4], twice in 1989 [5,6], and again in 1991 [7]. 

It should be noted that this paper has focused on GLP modifications proposed by the EPA for the analytical laboratory, it also should be noted that similar GLP regulations may soon follow from other agencies such as from agencies outside the country. 

It is unfortunate that public universities who are performing a public service will be required to comply with GLP s. It is also unfortunate that proposed GLP s are written in a way that may alienate the faculty that must try and conform. Some institutions may refuse to comply as a result, those who have made and might continue to make important and significant contributions to the those agencies that are imposing the regulations, will be lost. The authors suspect that the EPA will lose more than it gains. 

Characterization of the vector batch used in non-clinical safety studies is also performed in compliance with GLPs. Care should be taken to ensure that adequate and appropriate processes are used to produce the batch(es) required, and the production process should be similar to that proposed for production of the vector for human clinical trials, or at least performed in such a way that adequate documentation of the production methods is available for comparative purposes. The GLP regulations state that the identity, purity, and composition of the vector batch (test article) used in a safety study must be known and documented. In addition, the stability of the vector preparation in the specific container used for the study must also be known prior to initiation of the study or acquired concomitantly with the study itself. These test article characterization experiments require that the researcher produce additional amounts of vector identical to the material used in... 

US FDA. Good Laboratory Practice (GLP) Regulations, Proposed Rule. Federal Register, November 19, 1976. Vol. 41 51206-51230. http //www.fda.gov/ora/ compliance ref/bimo/ GLP/7 6proposedrule.pdf... 

The deficiencies observed in these inspections were summarized in the preamble to the proposed good laboratory practice (GLP) regulations (2) as follows ... 

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