Medical Device GMP (Good Manufacturing Practice) Inspections: An Analysis and Condensation of the Quality Audit Worksheet

摘要

A statistical analysis was performed of the results of the first 844 Good Manufacturing Practice inspections of device manufacturers. It was found that the Quality Audit Worksheet could be greatly condensed by eliminating some requirements that are rarely failed and by combining similar requirements. A set of relatively independent requirements was developed as a guide for condensing the worksheet and as a basis for calculating a compliance index for each firm. In addition, it was found that few requirements have different compliance rates for different types of devices. On the other hand, nearly all requirements were failed more often by small firms than by large firms. These results will be useful in planning and developing future compliance programs.