Cross August，Domestic sterile preparation enterprise new version of GMP certification check preparation work enters the countdown period，If the relevant application renovation work is not started at this time，It may face the dilemma of being revoked at the end of 2013。
 
Reporter roughly count the GMP inspection announcement issued by the State Food and Drug Administration (SFDA)，Currently among 1,200 sterile preparation companies in the country，Only 147 have passed the new version of GMP inspection and certification，Many companies may face risks that cannot meet the standard at the end of 2013。
 
From this，Enterprise mentality has differentiated，Some mainstream companies are actively preparing，Another part of the company will wait and see delay。Affected factors，It mainly depends on the future development strategy of the enterprise，and the company's expectations for its own and market development。
 
Enter the countdown
 
& ldquo; If the new version of the GMP certification has not yet started the application and transformation of the new version of GMP certification，It is likely that it will face the problem that it is difficult to meet the standard as scheduled.。& rdquo; Wei Qingjie, My stake betting appchairman stake online sports bettingof Huamin Pharmaceutical Co., Ltd., a subsidiary of North China Pharmaceuticals, said without worry，According to the current certification progress，Many companies still need to pass the new version of GMP inspection in the next year，Remove SFDA's follow -up approval link，A large number of on -site inspections are estimated to be concentrated before August 2013，Only in this way can ensure that the company gets the new version of the GMP certificate by the end of 2013。
 
This means，Cross August，The National Sterile Preparation Production Workshop has entered the final countdown stage of GMP transformation。It is understood，Most domestic sterile workshops are designed and invested 4 to 5 years ago，To meet the requirements of the new version of GMP，New solution design、workshop civil construction、Production line debugging and other hardware transformation，You also need to conduct personnel training、Software and technology upgrade、Repeated drill、Self -examination and self -correction, etc.，It takes at least 1 year。and usually check on the spot，It still takes half a year to get the new version of the GMP certificate。
 
But，At present, there are still very few companies that domestic sterile preparations pass through the new version of GMP。
 
Reporter saw on the SFDA website，As of now，SFDA released a total of 20 pharmaceutical GMP certification review of the 20 -stage sterile product，A total of 147 companies belonging to the production line passed on -site inspection and certification。and nearly 1200 nationwide sterile preparation enterprises。Where，Only 48 companies were checked by the manufacturer of a sterile powder needle preparation manufacturers，But the number of frozen -dried powder needles in the country is nearly 500，Companies that have passed the new GMP certification are less than 1/10。Hebei currently has a total of 19 sterile powder needle preparation manufacturers，But there are only 3 in the new version of GMP preparation production enterprises，is Huamin Company、North China Pharmaceutical Co., Ltd. and Stone Medicine Ouyi Pharmaceutical。
 
At present, the industry My stake betting appis stake sports betting appexpected to be expected to the above -mentioned new version of the GMP aseptic preparation certification，This causes the mentality of pharmaceutical companies to be gradually differentiated，Some companies are actively dealing with the GMP transformation of sterile products，Preparing for certification application materials, etc.，There are also some companies that are not positive when the new version of GMP is transformed，Even some manufacturers said & ldquo; even in 2015, there was no way to complete & rdquo;，Therefore, not in a hurry。
 
& ldquo; The period for implementing the new version of GMP has been included in the "National Drug Safety 12th Five -Year Plan"，Time node cannot be changed。& rdquo; Wei Qingjie suggests，New GMP inspection must not be relaxed to complete the task of checking the number of inspections，Otherwise, the new quality management concept cannot be implemented，Eventually, cause labor and people to hurt money，The meaning of the transformation will be lost。
 
At the same time, Wei Qingjie also said，Enterprises do not have to worry about being unable to renovate in accordance with the requirements of the new version of GMP，Because the inspection of the current expert group attaches more importance to the comprehensive risk control ability of the enterprise，instead of the requirements of the full -shot bars and frames in the past。

Determination of renovation
 
Some people familiar with the matter pointed out，The mentality of watching or delaying corporate watch，Mainly the corresponding product market benefits，or does not match with the main business direction of the enterprise，For example, the production line that exists to protect the product，Because they cannot determine the cost of the new version of GMP reconstruction，Can the future bring returns to enterprises。
 
& ldquo; The process of GMP certification transformation is actually equivalent to the re -adjustment process of the company's future development strategy。& rdquo; Wei Qingjie commented，At present, mainstream domestic enterprises have been actively preparing for the new version of stake online sports bettingstake online sports bettingGMP reconstruction，The transformed product line is all the main direction of the future development of the enterprise。
 
For example, the field of sterile cephalosporin，Huamin Company、Nanchang Lijian and other companies' cebon workshops have been invested in newly built in the past two years，The strategy of the enterprise is to develop the production and sales of cephalosporin preparations，Therefore, it is completely designed and constructed according to the new version of GMP，and actively apply for certification inspection from the beginning。
 
In the announcement of the certified cephalosporin sterile preparation enterprise，Sterile Cef Market Leading Enterprise，Including Huamin Huamin、Qilu、Nanchang Lijian、Baiyunshan General Factory、Stone Medicine Europe、Dalian Meiluo Pharmaceutical Factory、Hainan Kangzhi、Shenzhen Lijian、Shenzhen Jiuxin、Hainan He Rui、Shenzhen Zhijun, etc. already have a new version of GMP certificate in the production workshop。
 
Because the company knows，Since it will be passed sooner or later，The sooner you complete the development of the market, the more favorable it is，Especially in the current implementation results of the restrictions of sterile drugs, it has appeared，In the case where the new directory of each province has just been formulated，The market structure of the cephalosporin product is a good time for transformation and expansion。
 
This strategy has been verified soon，The reporter also learned，At present, some products of cephalosporin preparations start to be tight，Fast after the new version of GMP cephalosporin preparation companies have begun to benefit。For example, the three pharmaceutical production workshops of the New Cef Factory of Huamin Company have all received a new GMP certificate，At present, a group of enterprises such as Zhijun, Shenzhen are in the GMP transformation of other factory buildings，In order not to affect the product market，Entrusted Huamin Company for production。
 
For companies such as Zhijun，This approach guarantees Stake Sports Bettingstake online sports bettingthe smooth progress of the new version of GMP certification，And the company's products can also get quality -guaranteed manufacturers to produce，It can minimize the impact of GMP transformation on the market。
 
Wei Qingjie told reporters，The strategy of Chinese medicine is to achieve leapfrog development，The possibility of the future development of cephalosporin products is not much likely，But it will be very stable。So，Huamin's design concept and device advancedness completely surpass the requirements of the new version of GMP。& rdquo;
 
& ldquo; The daily operating cost of the new version of GMP is nearly 1/3，But these are necessary。Actually，Most of the mainstream enterprises are also the mentality of the implementation of the new version of GMP。& rdquo; Wei Qingjie finally said。