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GMP certification cancellation

  • Categories:Industry news
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  • Time of issue:2019-11-01 17:47
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(Summary description)In the future, the supervision and inspection records will become the proof that the enterprise meets the GMP requirements, because the law requires disclosure of all regulatory results. Each company, the result of each inspection, is the GMP compliance certificate.

GMP certification cancellation

(Summary description)In the future, the supervision and inspection records will become the proof that the enterprise meets the GMP requirements, because the law requires disclosure of all regulatory results. Each company, the result of each inspection, is the GMP compliance certificate.

  • Categories:Industry news
  • Author:
  • Origin:
  • Time of issue:2019-11-01 17:47
  • Views:
Information
In the future, the supervision and inspection records will become the proof that the enterprise meets the GMP requirements, because the law requires disclosure of all regulatory results. Each company, the result of each inspection, is the GMP compliance certificate.
 
What is the proof of compliance after ▍ GMP?
 
Recently, the industry authorities in an interview with Cypress Blue said: The cancellation of GMP/GSP certification is not new, it started a few years ago.
 
In the future, the supervision and inspection records will become the proof that the enterprise meets the GMP requirements, because the law requires disclosure of all regulatory results. Each company, the result of each inspection, is the GMP compliance certificate.
 
The above-mentioned person cites Cypress: the only thing that is cancelled is "certification", not GSP and GMP itself. Equivalent to the original "squid leaping dragon gate" - after this pass, you are a "good guy"; and now is a state - the regulatory authorities must maintain "continuous attention", simply "continuous compliance" "Pharmaceutical manufacturers must always maintain the entire production status is compliant, the regulatory authorities do not have to say hello, at any time to push the door to check.
 
He further stated that after the cancellation of the certification, the pharmaceutical companies no longer need to do the post-marketing certification inspection, the regulatory authorities put all the inspections before the listing, and continue to supervise the production through the daily supervision to comply with GMP, which is consistent with the practice in developed countries. .
  
  场地变更等管理需要现场检查,确认GMP状态的需要做好衔接,以优化工作程序,减少行政环节。
  
  ▍不用认证了,哪些企业会利好?
  
  1998年,中国参照国际标准推出了GMP认证,对企业从厂房到地面、设备、卫生、空气和水的纯化等各项生产环节提出明确要求,并强调所有药品不通过认证不得生产。
  
  和黄医药资深副总裁崔昳昤对赛柏蓝就此次事件表示,这次取消认证,看似是准入松了,但实际上监管部门把工作中心移到了事中事后监管,以后动态飞检会增加,查处力度会加大。所以药企的生产质量管理要更加重视,这考验的是药企的日常内功。
  
  另一名药企的质量管理负责人告诉赛柏蓝:以前生产新药的时候,必须有新药证书和GMP认证,现在取消了,那么这个药算是好还是不好,这需要企业去判断。此外,因为飞检频次加高,对日常管理的要求会更高,以应对不定期而来的飞检。
  
  崔昳昤进一步表示:GMP、GSP管理是药企的立身之本,质量是企业的生命线。作为药企,建立完善的质量管理体系,始终以GMP标准作为日常工作的习惯,不定期自查自纠,做好员工培训,将质量管理理念根植于员工心中。那么无论国家政策如何改变,企业自有信心应对。
  
  需要注意的是,某种程度上,取消GMP/GSP认证,是简政放权,释放政策红利——政府审批的事项减少,变成企业自身的要求,这对原来就重视质量管理的企业是利好,习惯于投机取巧的企业是威胁。
  
  ▍取消认证,为进一步推进MAH
  
  事实上,就如上文所说,取消认证的说法已在医药圈流传多年,而此次新版《药品管理法》表决通过,才算一锤定音,给行业吃了一剂定心丸。
  
  业内有观点显示,药品管理法修订的重中之重是药品上市许可持有人制度,围绕产品全生命周期和全过程监管,上市许可持有人依法对药品研制生产、经营使用权过程中药品的安全性、有效性、质量可控性负责,此时,如果仍然执行GMP认证,那么质量管理职责仍然在生产厂家身上,这会弱化上市许可持有人的相关职责。
  
  崔昳昤也表达了类似的看法,她认为取消认证,是为后续上市许可持有人(MAH)推进所做的准备,作为药品生产的第一负责人,上市许可持有人的质量管理体系超越了传统体系,对于药品的委托生产企业和销售企业要进行全过程管理,要设计更为完善的跨区域、跨企业的质量管理体系,这也是中国医药行业实现蜕变、行业资源优化整合的机会。

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