[Requirement for quality control of enzyme preparations]

Enzyme preparations are medicine which prepared from natural and biotechnological enzymes or modified enzymes. The catalytic ability of the preparations display the efficacy of a medicine, and its chemical substance is protein. From these characteristics, the quality of enzyme preparations has to be evaluated at viewpoints what distinguish from synthetic drugs. Quality of enzyme preparations should be evaluated and assured from the following viewpoints: 1) definition of enzyme source, 2) identification of function for catalyst and substance as protein, 3) purity for functional enzyme protein, 4) biochemical evidence that justifies pharmacological action, 5) safety, and 6) contents.