Abstract:
OBJECTIVE To solve various problems existing in the management of pharmaceutical raw material suppliers and to guarantee the quality of pharmaceutical preparations from the source by introducing drug master files(DMF) management system. METHODS DMF management system was used to manage the supplier. The advantages of this method was analyzed. RESULTS & CONCLUSION By using this method, it may improve the accuracy and objectivity of suppliers on-site auditing, reduce the quality risk and the cost of on-site audit, and guarantee the quality of suppliers on-site auditing. This method is beneficial to the raw material suppliers, pharmaceutical manufacturers and authorities. It also will make the suppliers on-site auditing be implemented truly, and guarantee the quality of pharmaceutical preparations better.