Good Laboratory Practice (GLP) is concerned with the process and conditions under which non-clinical laboratory studies are planned, performed, monitored, recorded, and reported. In a drug development company, the principles of Good Laboratory Practice are applied to the testing of drugs in clinical trials to obtain data that define the product's properties and safety. Both external (contract) and internal GLP programs are used. The decision to use external or internal testing is usually dictated by the type of drug being tested, the available company resources (financial and skilled personnel), and timing with respect to corporate development strategy. Although both programs must be compliant with GLP's, the implementation, development, and monitoring of these two programs are similar and yet quite different. For drug development companies the results of these studies are submitted to government authorities for the intended support of research and marketing applications. The assessment of the drug's safety to human health is the ultimate goal of GLP.
Considerations of Compliance Issues in Academic Core Facilities, N.M. Ritter and T.K. Hayes.
With the increased use of academic core facilities by biotechnology companies for the characterization of biomolecules comes the issue of compliance to regulatory standards. Should your academic core laboratory follow strict regulatory guidelines in order to service those customers for whom this level of activity is required? Should your company choose only those facilities that meet these requirements? What is the cost/benefit ratio to both parties for this level of compliance? Where in the product development cycle is it appropriate to use "spirit of GMP" academic core facilities versus full GMP analytical laboratories? Is there some middle ground that can be reached without exceeding economic or practical limits? These are the issues that face both core laboratory directors and facility customers, industrial or academic, who use the data to support biotechnology developments. We will discuss these topics and others that could impact the choices we make when faced with regulatory compliance.
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