质量风险管理在生物制药企业物料控制中的应用研究概述.docVIP

摘 要 研究目的：生物制药企业一般一个产品就要用到几十种物料，而企业的人力和财力是有限的，如果用同样的标准去管理的话，难以控制。本文希望通过研究找到可行的方法对物料实施分级管理，集中有限的人力和财力做好物料控制，同时满足药品质量和效益要求。 研究方法：本文首先通过风险排序方法按照物料的用途对物料实施分级，再基于物料的风险分级，采用失效模式的效应分析（FMEA）的风险管理工具，建立标准的供应商筛选和供应商动态管理程序，并对供应商实施风险评级，根据物料的风险级别和供应商的风险级别，采用相应的供应商管理策略和物料检验策略。 研究结果：生物制药企业可以将质量风险管理的理论和方法应用在物料控制中，降低物料控制环节的质量风险。 研究结论：生物制药企业通过质量风险管理的方法和手段进行物料的分级管理，可以降低物料控制的质量风险，为药品的安全性，有效性和质量可控性提供保障，并同时满足质量和效益的要求。 关键词： 物料控制 质量风险管理 生物制药企业 Quality Risk Management of Material Control in Biologics Industry in CHINA Research background: Materials, which are purchased by enterprises and used to produce their products, play a significant role in drug production. There have been many adverse drug events in recent years, of which the Qiqihar No. 2 Pharmaceutical Co., Ltd fake medicine event and the poison capsule event are both caused by problems of material control in drug production directly. With the reinforcement of GMP implementation required by SFDA, the material control plays an increasingly important role in quality management in pharmaceutical industry. Research objective: Usually, dozens of materials are used for the production of just one drug product in biologics industry. However, the financial and human resources are limited in enterprises, and it is difficult to use the same standard to manage all materials well. The objective of this study is to find a practical method for material classification management, which will result in good material control with limited financial and human resources, while achieving satisfactory drug quality and profit. Research method: Firstly, we classify the materials by their purpose according to risk ranking. Secondly, the standard supplier selection and dynamic management procedures will be established though Failure Mode and Effect Analysis (FMEA), a tool of risk management, based on the risk classification result for materials. Meanwhile, the risk classification will also be done for suppliers. In summary, different supplier manageme