制药企业《药品生产质量管理规范》体系与企业文化协同发展研究  

Synergistic Development of GMP System and Enterprise Culture in Pharmaceutical Enterprises

作　　者：孙涛 余泓 秦昆明 SUN Tao;YU Hong;QIN Kunming(School of Pharmacy,Jiangsu Ocean University,Lianyungang,Jiangsu,China 222005)

机构地区：[1]江苏海洋大学药学院,江苏连云港222005

出　　处：《中国药业》2022年第15期20-23,共4页China Pharmaceuticals

基　　金：江苏省高校哲学社会科学研究项目[2020SJA1721]。

摘　　要：目的探讨制药企业《药品生产质量管理规范》(GMP)体系与企业文化建设的关键结合点。方法以江苏省连云港市具有代表性的制药企业为例,采用“协同”“整合”理论分析制药企业GMP体系与企业文化建设的内在关系,构建相关模型,并提出塑造企业文化的建议。结果提出GMP体系与物质文化、制度文化、精神文化、行为文化4种企业文化的有机结合为主要内容的制药企业文化建设。制药企业应当抓住新版GMP实施的契机,以GMP标准体系建设为核心,最大限度地整合企业资源,塑造敢于创新、诚实守信、质量第一、担当责任的企业文化。结论制药企业以GMP体系建设为核心载体,有助于更好地开展企业文化建设。Objective To investigate the key point of the combination between the Good Manufacturing Practice(GMP)system and the enterprise cultural construction in pharmaceutical enterprises.Methods Taking the representative pharmaceutical enterprises in the Lianyungang City,Jiangsu Province as an example,the internal relationship between the GMP system and enterprise cultural construction in pharmaceutical enterprises was analyzed by the theory of"synergy"and"integration",the relevant models were constructed,and the suggestions on construction of enterprise culture were put forward.Results The cultural construction of pharmaceutical enterprises with the organic combination of GMP system and four enterprise cultures including material culture,institutional culture,spiritual culture and behavioral culture as the main content was proposed.Pharmaceutical enterprises should seize the opportunity of implementing the new version of GMP,take the construction of GMP standard system as the core,integrate enterprise resources to the greatest extent,and construct a enterprise culture of daring to innovate,honest,trustworthiness,quality first and responsibility.Conclusion The construction of GMP system is the core carrier of enterprise cultural construction,which is helpful to develop the construction of enterprise culture.

关 键 词：药品生产质量管理规范 制药企业 企业文化 协同 整合 

分 类 号：R95[医药卫生—药学]