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目的引入药物主文件(drug master files,DMF)管理制度以解决现有供应商管理中存在的各种问题,从根源上保证药品制剂质量。方法运用DMF管理制度对供应商进行管理,并分析其优势。结果与结论 DMF管理制度,可以提高供应商现场审计的准确性和客观性,降低审计的质量风险,减少审计成本,保证供应商管理的质量,于原料供应商、药品制剂厂家以及药监部门三方有益,不仅使供应商现场审计真正落到实处,供应商管理更加有效,更能有效保障药品制剂的质量。
Objective To introduce a drug master files (DMF) management system to solve various problems existing in the management of existing suppliers and to ensure the quality of pharmaceutical preparations from the root causes. Methods Using DMF management system to manage suppliers and analyze their advantages. Results and Conclusion The DMF management system can improve the accuracy and objectivity of auditing on the site of suppliers, reduce the quality risk of auditing, reduce the audit cost and ensure the quality of supplier management. In the three aspects of raw material suppliers, pharmaceutical preparation manufacturers and drug regulatory authorities Beneficial, not only true real-time audit of the supplier site, supplier management more effective, more effective protection of the quality of pharmaceutical preparations.