浅谈GMP标准化全面质量管理对制药企业的指导  

On the guidance of GMP standardized total quality management to pharmaceutical enterprises

作　　者：苏嘉洛 杜成林 SU Jia-luo;DU Cheng-lin(School of medicine and Life Sciences,Jinan University,Shandong Academy of Medical Sciences,Institute of medicine,Shandong Academy of Medical Sciences,Shandong Jinan 250200,China)

机构地区：[1]山东省医学科学院济南大学医学与生命科学学院,山东省医学科学院药物研究所,山东济南250200

出　　处：《临床医药文献电子杂志》2020年第25期181-183,共3页Electronic Journal of Clinical Medical Literature

摘　　要：《药品生产质量管理规范》(GMP),是质量管理发展到全面质量管理标准化阶段的产物。其设立的目的在于把药品生产过程中的质量风险尽可能降到最低,以保证药品的质量及用药的安全有效。目前,质量管理已经从最初的质量检验阶段发展到了如今的标准化全面质量管理阶段。说明了对药品质量的把关由事后检验转变为了强调标准化的全过程、全方位、全员质量管控,以达到全方位的事前预防。本文将从人员与机构、设备、物料与产品三个方面来说明GMP是怎样体现、贯彻并指导制药企业的标准化全面质量管理。GMP is the product of the development of quality management to the standardization of comprehensive quality management.The purpose of GMP is to minimize the quality risks in the pharmaceutical production process to ensure the quality of the drugs and the safety and effective of the drugs.At present,quality management has evolved from the initial quality inspection phase to today's standardized comprehensive quality management phase.It shows that the quality control of drugs is changed from post-test to emphasize the whole process of standardization,all direction and quality control of all employees to achieve all direction prevention.This article will show how GMP reflects,implements and guides the standardization of total quality management of pharmaceutical companies in personnel and institutions,equipment,materials and products.

关 键 词：GMP 人员与机构 设备 物料与产品 全面质量管理 标准化 

分 类 号：R194[医药卫生—卫生事业管理]