Good Laboratory Practice Regulations Research Articles

A GOAL PROGRAMMING MODEL FOR ALLOCATING HUMAN RESOURCES FOR THE GOOD LABORATORY PRACTICE REGULATIONS

ABSTRACTThe Food and Drug Administration's final Good Laboratory Practice regulation will have a far‐reaching effect on testing laboratories that are conducting nonclinical laboratory safety tests. This paper develops a goal programming decision model suitable for setting objectives, meeting budgetary and operational constraints, planning personnel utilization, and evaluating different proposals for allocating laboratory personnel to implement a program.

Impact of New Food and Drug Administration Regulations on College, University, and Experiment Station Researchers

The Good Laboratory Practice regulations adopted by the Food and Drug Administration describe specific procedures to assure the integrity of research results. Those studies conducted with the intent to provide data on the safety of drugs and chemicals will be required to comply with the published regulations. The process of bringing research laboratories into compliance with the regulations may be either arduous or fairly routine depending on the organization, goals, and type of research. Typically, the Good Laboratory Practice regulations will increase sharply the cost of health safety information. Hiring more and better trained technical and professional personnel will be much of this expense. If university and experiment station researchers choose to avoid compliance with these regulations, then agricultural research science may not continue to be recognized as an authority on the safety of products used for production of human food. Irrespective of whether universities choose to conduct regulated research or delegate this role to other segments of society, academic institutions must assume the role of training those individuals needed to conduct toxicity research.

Compliance with the New Food and Drug Administration Regulations: An Approach by Industry

Good Laboratory Practice regulations became effective on June 20, 1979. The regulations provide guidance for the proper conduct and reporting of nonclinical laboratory studies on articles regulated by the United States Food and Drug Administration. A fundamental requirement of the regulations is the establishment of a quality assurance unit within each research facility to ensure the utilization and maintenance of good laboratory practices. A second significant feature is the requirement for an archival unit responsible for maintaining all raw data, documentation, protocols, specimens, and final reports. Experience with the regulations has been mixed. The quality of reports has been upgraded dramatically. Protocols contain more information than ever, data recording is more extensive and more carefully executed, and reports are prepared more carefully and edited more thoroughly. Conversely, there is no real evidence that quality of science has been improved, and costs have increased markedly.