药品质量受权人参与企业的质量管理活动，承担药品放行的职责，确保每批放行产品的生产与检验均符合相关法规、药品注册要求和质量标准。药品质量受权人的职业道德和法律意识直接影响药品的质量和安全。此文陈述了我国实施药品质量受权人制度的基本情况和存在的问题，同时对药品质量受权人提出职业道德要求，并梳理药品质量受权人需要承担的法律责任和风险，旨在提升药品质量受权人的职业素养和法律意识，进一步确保药品质量受权人的履职能力。 关键词 质量受权人；质量受权人制度；职业道德；法律责任和法律风险。

The drug qualified persons（QPs） engage in the quality management activities of pharaceutical enterprises, take responsibilities for the product release，and ensure that the production and inspection of each batch of released products meet the relevant laws and regulations, drug registration requirements and quality standards.The professional ethics and legal consciousness of the drug QPs directly affect the quality and safety of drugs. This paper states the basic situation and existing problems of the implementation of the drug QP system in China, as well as puts forward professional ethics requirements for the drug QP, and sorts out the legal responsibilities and risks that the drug QP needs to bear, aiming to improve the professional quality and legal awareness of drug QPs and further ensure the ability of drug QPs to perform their duties.