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质量受权人制度,是在经历了“质量是检验出来的”和“质量是保证出来的”两个阶段实践后,目前感到最为有效的药品质量管理模式。我国从2009年4月开始推动这项制度,上海正在分阶段实施。在这个过程中,上海市质量协会医药委员会做了一项很有意义的调研工作。这项直接面对药品企业质量人的调研,摸清了上海市药品企业质量负责人的素质能力和工作现状,并为实施好质量受权人制度,提出了很好的建议。其中尤为值得关注的是“确立质量受权人法律地位”的建议。因为人的权力源自法律规定,只有从法律上赋予质量受权人应有的权力,质量受权人实施产品放行的职责时才能不受干扰。这样,企业才能真正把确保产品质量的社会责任落到实处。因此,保证质量受权人的独立性和权威性,是质量受权人制度成功实施的关键。这对药品生产以外的企业实施有效的质量管理,同样具有重要借鉴意义。
The quality attorney system is the most effective drug quality management model that has come into effect after two stages of “quality is tested out” and “quality is guaranteed.” Since April 2009, China has promoted this system and Shanghai is implementing it in stages. In this process, the Shanghai Quality Association Medical Committee made a very meaningful investigation. This direct investigation of the quality of pharmaceutical enterprises, find out the quality of the Shanghai Pharmaceutical Industry Quality and capacity of the current situation, and for the implementation of the system of quality attorney, put forward a very good proposal. Of particular concern is the proposal to establish the legal status of quality attorney. Because human rights are derived from the law, interference can only be obtained when legally assigning due rights to the mass attorney, the quality of the attorney to perform product release duties. In this way, companies can truly implement the social responsibility of ensuring product quality. Therefore, to ensure the independence and authority of the quality attorney is the key to the successful implementation of the system of quality attorney. This is also an important reference for the implementation of effective quality management of enterprises outside the pharmaceutical production.