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现代社会随着物质生活水平的不断提高,人们对健康的追求也越来越高。诊断、预防和治疗疾病的药品与每个人的健康息息相关,近年来不断出现的药害事件引起了全社会的关注,作为特殊商品,药品的质量和安全需要更多的重视。于2011年3月1日正式颁布实施《药品生产质量管理规范(2010年修订)》(以下简称新版GMP)对药品生产企业提出了更高的要求,与世界卫生组织颁布的《药品生产质量管理规范》的要求基本一致。新版GMP实施后的药企认证情况表明高标准的质量管理体系是通过新版GMP认证的前提。国家食品药品监督管理局要求现有药品生产企业必须在5年内通过认证,否则不得继续生产,对于药企来说,高标准质量管理体系的构筑和完善势在必行。现从资源管理、药品生产、监督以及信用管理和内部要求等方面进行解析。
With the continuous improvement of material living standards in modern society, people’s pursuit of health is also getting higher and higher. The medicines that diagnose, prevent and cure diseases are closely related to everyone’s health. In recent years, the emerging phytosanitary events have aroused the concern of the whole society. More attention should be paid to the quality and safety of special commodities and medicines. On March 1, 2011, the formal promulgation and implementation of the “Code of Practice for the Quality Control of Pharmaceutical Production (2010 Revision)” (hereinafter referred to as the new version of GMP) put forward higher requirements for pharmaceutical manufacturers, and the World Health Organization promulgated the “Quality Management of Pharmaceutical Production Norms ”requirements are basically the same. After the implementation of the new version of GMP pharmaceutical certification shows that a high standard of quality management system is the prerequisite of the new GMP certification. The State Food and Drug Administration requires that the existing pharmaceutical manufacturers must pass the certification within 5 years, otherwise they can not continue to produce. For the pharmaceutical enterprises, it is imperative to build and perfect a high-standard quality management system. Now from the resource management, pharmaceutical production, supervision and credit management and internal requirements and other aspects of analysis.