GLP/cGMP COMMITTEE The purpose of this newly formed ABRF committee is to gather and disseminate information concerning the development of biomolecules into a form approvable by the Food & Drug Administration. The regulations for conducting this research are known as the GLPs (Good Laboratory Practices) and the cGMPs (current Good Manufacturing Practices). They are a set of guidelines for conducting research in a manner which will enable the company to receive FDA approval to market a drug. These regulations cover the development and validation of methods designed to control the purity, identity, potency and quality of a drug. They also govern the processes and equipment used in the manufacture, distribution and labeling of drugs. As the biotechnology field matures, GLP/cGMPs are becoming increasingly important to academic, biotech and pharmaceutical labs. The major differences in the way research is conducted can be seen in the amount of work required to develop and validate methods and in the level of documentation required. The first public activity of the GLP/cGMP Committee will be a workshop at the 1994 Protein Society Meeting, entitled "GLP/cGMP Compliance: What does it take?". This workshop will give a glimpse of the changes that can be expected in the way research is conducted as a molecule moves from research through development. Our speakers will discuss regulatory issues in biotechnology as well as in the validation of amino acid analysis and peptide mapping methods. We hope you enjoy the workshop and will take the time to complete a survey that will be distributed at the meeting. This survey will better define the GLP/cGMP needs of ABRF members.
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