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对所有疫苗生产、销售等全流程全链条进行彻查

来源:网络整理 编辑:管理员 时间:2020-10-08

近日,长春长生生物科技有限公司(下称“长春长生”)“狂犬病疫苗生产记录造假”及“百白破疫苗效价不符合规定”两起事件备受关注。

李克强总理就疫苗事件作出批示:

The vaccine case has crossed a moral line, and the nation deserves a clear explanation.
此次疫苗事件突破人的道德底线,必须给全国人民一个明明白白的交代。

李克强在批示中要求,

The State Council should immediately send a group to thoroughly investigate the production and selling chain of vaccine, to uncover the truth as soon as possible, and any wrongdoing will be severely punished regardless of who is involved.
国务院要立刻派出调查组,对所有疫苗生产、销售等全流程全链条进行彻查,尽快查清事实真相,不论涉及到哪些企业、哪些人都坚决严惩不贷、绝不姑息。

Any illegal acts that could harm the people's lives should be severely cracked down and people behind it punished in accordance with law. Any dereliction of duty in the supervision authority should be held accountable, and we should give the people a living environment that is safe, trustworthy and credible.
对一切危害人民生命安全的违法犯罪行为坚决重拳打击,对不法分子坚决依法严惩,对监管失职渎职行为坚决严厉问责。尽早还人民群众一个安全、放心、可信任的生活环境。

针对“狂犬病疫苗生产记录造假”事件,昨日,国家药监局在官网通报最新调查进展。

对所有疫苗生产、销售等全流程全链条进行彻查

A child is vaccinated in hospital in Southwest China's Guizhou province on April 25, 2018. [Photo/VCG]

According to the investigation, the company counterfeited the vaccine’s production and inspection data, and changed the parameters for equipment and processing the vaccine.
通报说,现已查明,企业编造生产记录和产品检验记录,随意变更工艺参数和设备。

目前,已责令企业停止生产(terminate the production),收回药品生产质量管理规范(Good Manufacturing Practices,GMP)证书,同时会同吉林省局已对企业立案调查,涉嫌犯罪的移送公安机关追究刑事责任(the cases of those suspected of violating laws will be transferred to public security departments)。

GMP(Good Manufacturing Practices),(胃病什么程度可以住院),中文含义是“生产质量管理规范”或“良好作业规范”、“优良制造标准”。

Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices.
“良好作业规范”是监管部门审批和发放食品饮料、化妆品、药品、膳食补充剂以及医疗设备时要遵照的规范要求。

These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user.
这些规范是生产方确保所有批次产品保证高质量并且有效的基本要求,每个行业的具体规范或有不同,但GMP的核心目标是防止产品对终端用户产生有害影响。

国家药监局表示,已部署全国疫苗生产企业进行自查,确保企业按批准的工艺组织生产,严格遵守GMP生产规范,所有生产检验过程数据要真实、完整、可靠,可以追溯。

国家药监局将组织对所有疫苗生产企业进行飞行检查(unannounced inspections),对违反法律法规规定的行为要严肃查处。

【起因】

事情的起因是7月15日,国家药监局宣布发现长春长生生物科技有限责任公司生产的狂犬病疫苗造假。

The State Drug Administration has launched an investigation of Changchun Chang­sheng Bio-tech Co, which was found to have fabricated production records for freeze-dried rabies vaccines for human use.
国家药品监督管理局组织对长春长生生物科技有限责任公司开展检查,发现长春长生“冻干人用狂犬病疫苗”生产存在记录造假等严重违反《药品生产质量管理规范》的行为。

据《中国证券报》报道,接近长生生物的一位疫苗业资深人士说,此次事发是因为长生生物内部生产车间的老员工实名举报。

一波未平,一波又起。

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