ZSHT制药有限公司质量控制与改进研究.pdfVIP

摘 要 药品作为一种预防和治疗人类疾病的特殊商品，其质量优劣直接关系到人 们的生命健康与安全。特别是随着经济的迅猛发展和社会的不断进步，人们对 药品质量的要求越来越高，国家对药品的监管也越来越严。然而，进入 21 世 纪以来，在我国发生的多起药害事件和不良反应事件，引起了社会的关注和制 药企业的警觉。在药品制造过程中，GMP 规范仅仅是保证产品质量的基础， 如何在制造过程中有效的实现质量控制和风险防范，是制药企业期待寻求的对 策。为此，如何有效保障药品质量是药品制造企业所必须解决的课题。 本文首先介绍目前制药行业的现状，有关药品质量及质量管理理论，以及 药品 GMP 的发展历程，进一步阐明加强药品质量管理的重要性。其次，结合 公司现有产品的实际，选择有代表性的剂型——片剂作为切入点，对其代用质 量特性指标进行全面的分析，找出在产品实现阶段影响其质量指标的关键因素。 最后，依据公司生产实际，结合即将进行新版 GMP 认证的实际情况，总结药 品生命周期中的主要质量影响因素，并进一步分析、制定出具体的改进措施。 通过本文的研究论述，以期对本公司的质量管理和认证有所帮助，也希望 对其它公司的质量管理有所启发。 关键词：药品；质量控制与改进；生命周期；GMP ；风险管理 ABSTRACT The drug as a special commodity for the prevention and treatment of human diseases, its quality is directly related to peoples health and safety. Especially with the rapid development of economic and society, increasingly high demand is requested by the public and regulations about drugs are more and more strict. However, since twenty-first century, many medical events and adverse events about drugs have occurred, which cause the social concern and awareness of pharmaceutical companies. In the drug manufacturing process, the GMP specification is just the basic guarantee of product quality, what the majority of pharmaceutical companies expect to seek is that how to achieve effective quality control and risk prevention measures in the process of manufacturing. Therefore, how to effectively guarantee the drug quality is an important issue which every pharmaceutical manufacturing enterprise needs to solve. This thesis firstly introduces the current situation of the pharmaceutical industry, pharmaceutical quality and quality management theories, as well as the development process of GMP, and expounds the importance of strengthening drug quality management. Secondly, combined with the existing product, choose the representative tablet as the breakthrough point, make a comprehensive