2016年3月23日，多家报纸头条竞相报道山东毒疫苗事件。据报道，山东警方破获案值5.7亿元非法疫苗案，疫苗未经严格冷链存储运输销往多个省市。事件引发媒体激烈讨论，消费者也开始质疑中国药物监管机构监管手段以及监管力度。首先，失效疫苗并不是毒疫苗，其次今天文章的重点不是讨论疫苗是不是否有毒，而是带大家从毒疫苗事件了解药品市场质量控制规范手段。
药品即是一种特殊商品，又是一把双刃剑。质量优秀的药物可以帮助人类与疾病抗争，用于疾病的防治诊疗。生物制药具有五个基本特性：复杂性，专属性，两重性，隐蔽性以及局限性。基于以上特性，每一批次的产物都有可能不尽相同。所以生物制药制作的过程被监管并规范化，从而达到每一批次细胞的反应条件相同，细胞产物也一样。除制作过程以外，药物产业链必须进行全面质量控制 (TotaI quality control，TQC)， 涉及研发、生产、储运、供应、调配和应用等多个方面。如药物产业链中任何一个质量控制出现了疏忽或漏洞，质量不过关的药物流入市场则成为了谋财害命的工具。相应地，为了更好地监管控制药物质量，各国当权机构根据实际情况制定了相应法规文件并严格执行。如美国的食品药品监督管理局(FDA)，欧洲的欧洲药物管理局(EMA), 以及中国的食品药品监督管理局(CFDA)。
图片来源：(U.S. Food and Drug Administration)
著名毒药事件之一的反应停事件在1950年后期震惊世界。原联邦德国格仑南苏制药厂(Chemie Grünenthal) 旗下产品反应停(又称沙利度胺Thalidomide) 曾作为 治疗妊娠反应的镇静药在欧洲与日本被广泛使用。该药物的使用者流产率急剧上升，未流产的孕妇则生出患有海豹肢症 (Phocomelia) 畸形胎儿。后来研究发现该药物有两种对应异构体，其中一种异构体有镇静作用，另一种却具有致畸性。辛运的是美国FDA进行了冗长而繁琐的市场准入调查，拒绝反应停流入美国市场，从而保护了消费者。这个故事足以说明药品质量控制的重要性以及必要性。
图片来源: (生物谷: 向死而生！盘点那些死而复生的药物)
从原料进厂开始一直到市场投放，质量控制贯穿整个药品的生产、销售过程。质量控制包含两个大方面，一个是质量管理，一个是质量检测。质量检测为为质量管理提供信息，覆盖了药物研发生产的每个环节，包括研发、药物的合成、提取纯化、药物的结构和组成、药品质量标准的制定。全面质量控制 (TotaI quality control，TQC) 主要涉及以下规范及标准：
- 药品非临床研究质量管理规范(GLP, Good Laboratory Practice),
- 药品临床研究质量管理规范 (GCP, Good Clinical Practice)
- 药品生产质量管理规范 (GMP, Good Manufacturing Practice)
- 药品经营质量管理规范 (GSP, Good Supply Practice)
图片链接
Reference
- http://www.bioon.com/3g/id/6672886/
- http://www.weixinrensheng.com/v131hwwy/
- https://www.pda.org/docs/default-source/website-document-library/chapters/presentations/southeast/glp-vs-gmp-vs-gcp.pdf?sfvrsn=6
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