药品供应商现场质量审计及常见问题分析

On Site Quality Audit of Drug Suppliers and Analysis of Common Problems

原料、辅料和包装材料是在组成药物制剂的主要成分,作为药品制剂生产企业,原辅包的质量将会直接影响到最终制剂的产品质量,为保证产品质量,对原辅包供应商进行质量审计是有必要性的。本文从质量风险角度入手,对原辅包现场质量审计的要求和在审计过程中经常遇到的问题进行分析,运用风险管理的模式,科学有效地提高现场审计的质量。

Raw materials,excipients and packaging materials are the main components of pharmaceutical preparations.As a pharmaceutical preparation manufacturer,the quality of the original and auxiliary package will directly affect the product quality of the final preparation.In order to ensure the product quality,it is necessary to audit the quality of the original and auxiliary package suppliers.From the perspective of quality risk,this paper analyzes the requirements of the on-site quality audit of the original auxiliary package and the problems often encountered in the audit process,and uses the risk management mode to improve the quality of on-site audit scientifically and effectively.