& ldquo; This topic will discuss this topic today，It's hard to say at present。& rdquo; At the State Food and Drug Administration issued the "Announcement on Carrying out the checkup of drug production technology (draft for comments)" (hereinafter referred to as & ldquo; "Draft for Seding Opinions" & rdquo;，When a reporter calls a telephone contact with a pharmaceutical company,，Get this reply。Multiple versions of the process check -up work that were previously circulated，The hanging net of the "Draft for Soliciting Opinions" on the afternoon of August 11 was finally confirmed，One time，Friends have a lot of waves。

 

  "Draft for Consultation"，From the date of the announcement of this announcement，Pharmaceutical manufacturers should conduct self -examination in response to the production process (traditional Chinese medicine system method) that approve the listing of drugs (Chinese medicine)，Remove the hidden dangers of quality and safety。Enterprise should complete self -check before October 1, 2016，And the self -inspection situation is reported to the provincial food and drug supervision department of the local level，Research and verification of the My stake betting appproduct My stake betting appspecies production process before June 30, 2017、Submit related work such as supplementary applications，The time for the application for the company to make up for the product species is 8 months，Other non -production species should complete the above work before December 31, 2017。Another，One month after the company completes the self -inspection work，that is, from November 1, 2016，The State Food and Drug Administration will organize experts to conduct flight inspections on pharmaceutical manufacturers。

 

  Quality supervision is getting thinner

 

   & ldquo; On the whole, we believe that the expression of the "Draft for Soliciting Opinions" is more objective，With the idea of ​​discovering problems and solving problems to deal with the problem of irregular changes in my country's pharmaceutical production technology。The idea of ​​this idea is inherited from the past inheritance and prescription verification specifications，But this time it is more thorough。& rdquo; Yan Jie, the person in charge of R & D of Shenzhen Xinlitai Pharmaceutical Co., Ltd.。

 

  "Draft for Consultation" mentioned，Some varieties approved for listing before 2007 were not produced in accordance with the approval production process、Change production technology does not study and declare as required。Reporter found，In the past year，In the flight inspection of the State Food and Drug Administration，The root causes of various problems in the informed enterprise lies in the change and irregularity of the production process。

 

  April this year，The State Food and Drug Administration found in a flight inspection of Guizhou Shouxian Pharmaceutical Co., Ltd.，This company exists in the drug GMP certificate and continues to produce drugs illegal，Change some product batch number，Production records、Inspection records and material records are suspected of fraud，Suspecting anti -ingredients，Material management chaos and other problems。Discovered in the flight inspection of Hebei Yongfeng Pharmaceutical Co., Ltd.，The enterprise exists without authorization stake online sports bettingto stake sports betting appchange the sterilization process of intermediate products、The original medicinal materials test records are not real and other problems。Gansu Dateli Pharmaceutical Co., Ltd. mainly exists in the lack of raw materials quality assurance measures，There are higher quality risks，Production management is not in place，Lack of necessary process control，Quality management is not in place，Lack of key control projects and other problems。

 

  Qin Weihua, Executive Deputy Director of the New Medicine Research and Development Center of Sun Yat -sen University Pharmaceutical College, said，The control of the production process is very critical for the quality of the drug。Some products provided by the existence of raw and drug companies in the past are not produced in the upstream link，Instead, buying other companies (including chemical enterprises) products directly，This is here，Preparation companies are difficult to grasp the quality of the upstream products of the raw medicine。The scope of this production process self -check inspection covers all medicines，Including raw materials，You can control the product quality from the source in advance，It can also be better guaranteed for preparation products。

 

  An unnamed business person told reporters，Some companies have been produced in the past，Because after getting the approval,，When the product is optimized and adjusted for the product，The declaration procedure for changing production process is not particularly clear，Enterprises do not know how to determine the nature of the quality，To avoid tedious procedures，Select not to report。Another，Slow of drug approval is also one of the factors for enterprise declaration considerations。

 

  With the consistency evaluation of the previous introduction、Clinical data self -examination verification、MAH pilot and other policies，You can clearly see from it，State regulatory authorities will be stricter and standardized for drug quality supervision。The problem that has not been refined in policy is also being adjusted。

 

  stake betting appThe My stake betting appstrict requirements of the industry's product quality in the industry are like & ldquo;，It will also remind companies in the future production and operation，Not only the market to occupy the market，Also pay attention to product quality and efficacy。

 

  Pressing time is a bit urgent

 

  Xiao Wenson, general manager of Guangzhou Xidian Pharmaceutical Technology Co., Ltd. said，Self -examination of corporate craftsmanship is actually not difficult，Complete the material supplement in time，But for companies that have changed the production process at will for the past，Due to the lack of document information at that time，The situation will be much more complicated。In his opinion，This forms a combination of combination with consistency evaluation，It will eliminate a lot of unqualified products left before。

 

   & ldquo; The direction of "Draft for Consultation" is very clear，But I feel this time in terms of time requirements，The time left for the enterprise is not enough。There are still many things that are not very clear at present。& rdquo; Some businessmen report to reporters。

 

  Reporter noticed，In an interview，Many people in the industry reflect the problem of insufficient time。Through this self -examination，Each enterprise has many varieties to do self -examination and research，Consider the situation of other work and personnel，8 months of 8 months is obviously a bit short。Through this self -examination，It can make companies that can ensure that quality production technology becomes clearer，More compliance。They are looking forward to the application for the future，can be more streamlined and targeted，It is conducive to the company's light -fitting。

 

  Actually，As early as the requirements of the new version of GMP，It is clearly mentioned that it is necessary to develop medicines that meet the standards of drug quality management，Strengthen the verification of the R & D and production process，This also puts forward higher requirements for the quality supervision personnel of the enterprise。stake sports betting appFrom My stake betting appanother level,，The improvement of this quality requirements will also affect the idea of ​​pharmaceutical companies in product development。

 

  Qin Weihua said，The declaration of a new medicine starts from the laboratory，Large -scale production later is actually amplifying production，From the laboratory to the factory，There is a gap between the production process between the two，It is promoted to consider when it is promoted when developing and developing，If this new drug is amplified，Is it feasible in technology and quality? at the same time，Intellectual property awareness under large -scale production will also increase with the standardization of production processes，Protect the management steps of some drugs in production as much as possible，To maintain the intellectual property right of the product。