Under the circumstance where the flight inspection is increasingly frequent，Many pharmaceutical companies have been recovered by GMP certificate，Among them, the exposed raw and auxiliary materials are worthy of attention。Recently，The State Food and Drug Administration issued an announcement，During the flight inspection, it was found that a pharmaceutical company in illegal Jilin was retracted by the illegal Jilin Pharmaceutical company。There are media statistics，This year's State Food and Drug Administration issued a total of nearly 20 pharmaceutical companies' flying inspection announcements，Among them, there are 10 problems involved in the supplementary materials，The proportion of more than half。Some medical people bluntly said: & ldquo; The raw and auxiliary materials have now become a living and death factor affecting the variety。& rdquo;

 

   & ldquo; The problem of the raw and auxiliary materials exposed recently is actually the corner stake betting appof the stake betting appiceberg，Many preparation manufacturers have developed a habit before，The raw and auxiliary materials entering the factory are not inspected，Even forged inspection records。& rdquo; Zhang Hailong, technical director of Shenzhen You Including Pharmaceutical Co., Ltd., revealed in an interview with the "Medical Economic News" reporter，In terms of supplier audit，The original foreign company in real estate is better。Many domestic pharmaceutical companies do not audit the auxiliary materials enterprises，Even if the audit，It may also just walk through the field。This indirect indulgence of the auxiliary material company's production process，Since the regulatory agency does not directly manage，The downstream pharmaceutical companies have not fulfilled the supervision responsibility，So often & ldquo;。

 

  Strengthening the supply chain management

 

  Different supply chain and medicine for pharmaceutical auxiliary materials in my country。Researchers from Beijing Fanson USki Pharmaceutical Co., Ltd. pointed out，Many auxiliary materials manufacturers are food or chemical enterprises，Pharmaceuticals exist on the supply chain & ldquo;，That is, the same product can be used as a food additive、Chemical raw materials and medicinal auxiliary materials，It is easier to bring chaos to the sales of medication auxiliary materials。

 

  In addition，The supply chain of medicinal auxiliary materials not only includes manufacturers and end users，It also includes sub -packaging providers、Agent and other links; procurement accessories such as pharmaceutical manufacturers often do not directly contact the medicinal accessories producers。So，The supply chain of medicinal auxiliary materials is not easy to get strict control。

 

  & ldquo; On the one hand, it is necessary to accelerate the research and formulation of relevant production specifications，On the other hand, we must further stake betting appMy stake betting appstrengthen supervision and inspection，Urgent enterprises to continue to produce in compliance。& rdquo; A spokesperson for the State Administration of Food and Drug Administration emphasized。

 

  Preparation manufacturer as the first responsible person for drug safety，Strengthening the supply chain management is to reduce quality and safety risks、An important part of producing high -quality drugs。From the perspective of the industry expert，Reliable supply chain involves multiple aspects，For example, the recognition of the raw and auxiliary materials and suppliers，It must ensure the consistency of the raw materials and suppliers; the certification of the supplier; very critical risk management, etc.。

 

   & ldquo; Due to rigorous supervision，Most preparation companies purchase high -quality auxiliary materials from compliance pharmaceutical auxiliary manufacturers，and standardized。& rdquo; The person in charge of Erkang Pharmaceutical said，Especially injection production enterprises，The awareness of the quality risk control of the auxiliary materials is stronger than the past。

 

  It is worth noting that it is，APIP、Keep materials must be evaluated by the supplier，After passing, it can be listed as a qualified supplier。In the future, the auxiliary materials provided by these qualified suppliers must also be checked，Many testing items of accessories are special，The difficulty of inspection and the requirements of equipment and equipment are high，Many domestic small companies do not have inspection conditions，It can be implemented by commissioned inspection。

 

  Forced GMP steering

 

  During the interview，Experts point out，Foreign auxiliary materials supervision risk grafting to preparation production enterprise，Regulatory agencies do not directly supervise the auxiliary materials production enterprises，Domestic is now this trend，You can see this point stake sports betting appfrom Stake Sports Bettingthe affiliated review of the new policy。From the perspective of international experience，March 2015，The EU issued a proper GMP regulations based on risk assessment for accessories manufacturers，and officially implemented in March 2016。

 

  & ldquo; Accessories are non -active ingredients，Copy API's GMP standard is some of the control，Therefore, the European Union introduced the appropriate GMP based on risk assessment。& rdquo; Zhang Hailong told reporters，Supplementary material production enterprises can make risk assessment based on the functional indicators of the auxiliary materials and the way to administer it，Establish an enterprise's own quality system，In order to cope with the supplier audit of the preparation manufacturer，China will also be this mode in the future，Will strengthen the supplier's audit，Third -party audit will gradually be recognized，For example, the Excipact certification of IPEC。

 

  Specifically，The focus of the future is not that the compulsory auxiliary materials enterprise executes some kind of GMP，Instead, it is to evaluate the quality control system of the auxiliary materials enterprise to ensure the quality of the product，Can it continue to produce medicinal auxiliary materials that meet the established standards。

 

  During the interview，The aforementioned experts also put forward targeted recommendations on the current dilemma of pharmaceutical assistance and pharmaceutical companies。The responsibility of the pharmaceutical company is to improve the internal control standard of the auxiliary materials，Reaching a quality agreement with the auxiliary materials enterprise，Guarantee per batch of inspection，Inspection of unqualified accessories requires quality description。In addition, strengthen the on -site audit of the auxiliary materials enterprise，The control My stake betting appof stake betting appthe quality system of the auditing auxiliary material enterprise on the key indicators of the product，Tracking historical production and inspection records。

 

  Accessories enterprises need to be based on existing regulations，For example, EU、IPEC、GMP requirements of CFDA，Make risk assessment for different auxiliary materials，Establish a truly controllable quality system，If possible, you can introduce a third -party quality certification system。