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根据《药品生产质量管理规范》(以下称药品GMP)的规定,对于药品生产企业而言,药品质量管理人员至少应当包括企业负责人、生产管理负责人、质量管理负责人和质量受权人等关键人员。在药品监管部门贯彻落实药品安全“四个最严”的新要求下,药企质量管理人员尤其是企业负责人和质量受权人应明确其承担的法律责任和应尽义务。药企负责人或承担三大法律责任药品GMP第二十一条明确规定,企业负责人是药品质量的主要责任人,全面负责企业日常管理。企业负责人的主要职责是确保企业实现质量目标并按照GMP要求生产和经营药品,企
According to the provisions of “Good Manufacturing Practices for Pharmaceutical Products” (hereinafter referred to as “GMP”), for drug manufacturers, the quality control personnel of pharmaceutical products should at least include the key of enterprise manager, production manager, quality manager and quality attorney personnel. Under the new requirements of the “four most stringent” drugs regulatory authorities to implement the drug safety, the quality management personnel of pharmaceutical and pharmaceutical enterprises, especially the business owners and quality attorneys, should make clear their legal responsibilities and due obligations. Article 21 of the GMP, which is the person in charge of the pharmaceutical enterprise or undertakes the three major legal liabilities, clearly stipulates that the person in charge of the enterprise shall be the main responsible person of the pharmaceutical quality and be fully responsible for the daily management of the enterprise. The main responsibility of business owners is to ensure that enterprises achieve quality objectives and in accordance with GMP requirements of the production and operation of pharmaceuticals, enterprises