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    Home > Active Ingredient News > Drugs Articles > GMP of hundreds of pharmaceutical enterprises confiscated

    GMP of hundreds of pharmaceutical enterprises confiscated

    • Last Update: 2015-11-03
    • Source: Internet
    • Author: User
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    Source: Beijing business daily 2015-11-03 with the arrival of the new GMP certification time node, pharmaceutical enterprises also ushered in the largest and most frequent "flight inspection" ever According to incomplete statistics from Beijing business daily, as of yesterday, 100 pharmaceutical companies have been withdrawn GMP certificates (i.e the "GMP for drug production quality management"), far more than 50 in the whole year of last year Among them, 63% are Chinese medicine enterprises Industry insiders believe that with the approaching of the new GMP certification limit, the shuffling of traditional Chinese medicine industry is also accelerating The number of drug companies holding certificates has doubled According to the incomplete statistics on the enterprises with GMP certification withdrawn issued by the State Food and drug administration, as of yesterday, 100 drug companies in 19 provinces in the country have withdrawn GMP certificates, of which 63 enterprises produce traditional Chinese medicine and herbal pieces The reasons for the withdrawal of GMP certification include false production records, false inspection records, production of Chinese Herbal Pieces beyond the scope, confusion in production management, illegal production of Chinese herbal pieces, and major defects in the quality management system Last year, only 50 enterprises were confiscated of GMP certificates, but this year, the number of enterprises whose certificates have been confiscated has doubled To this end, Shi lichen, head of Beijing Dingchen medical management consulting center, believes that the state has increased supervision and investigation this year, which also made many enterprises "missed the net" last year There is no hiding in this year's inspection, and the number has increased correspondingly It is understood that there are two time nodes in the new GMP certification: the enterprises producing blood products, vaccines, injections and other sterile drugs should meet the requirements of the new GMP before December 31, 2013; the manufacturers of other categories of drugs represented by traditional Chinese medicine and herbal pieces should meet the requirements of the new GMP before December 31, 2015 Requirement Enterprises that fail to meet the requirements shall not continue to produce drugs after the time limit prescribed above This means that if Chinese medicine enterprises do not want to face the dilemma of factory shutdown, they must pass the above inspection before the end of this year According to the data, 63 of the 100 enterprises whose certificates have been withdrawn are enterprises of traditional Chinese medicine and herbal pieces Industry insiders said that the reason why traditional Chinese medicine enterprises have become the disaster area of "receiving certificates" lies in that, on the one hand, the State Food and drug administration has listed traditional Chinese medicine enterprises as the key inspection objects in the "flight inspection", and has stepped up the inspection and cleaning of the implementation of GMP in pharmaceutical factories before the "big limit is coming"; on the other hand, although the production of traditional Chinese medicine has implemented GMP Compulsory certification, but compared with the pharmaceutical production enterprises, traditional Chinese medicine and Chinese Herbal Pieces production enterprises generally have low level of production quality management The phenomenon of packaging or changing labels, renting and lending licenses, opening bills and so on often occurs Even some enterprises still commit crimes against the wind after being confiscated GMP certificate On March 27 this year, the official website of the State Food and Drug Administration announced that during the "flight inspection", it was found that there were illegal problems in the production and operation of 10 Chinese Herbal Pieces production enterprises, including ren'an pharmaceutical In response, the State Food and Drug Administration issued a circular to 10 pharmaceutical enterprises and took back GMP certificates One of the enterprises, Taiyuan traditional Chinese medicine, continued to organize production after the certificate was confiscated So this year, the State Food and drug administration also increased the frequency and intensity of "flight inspection" With the promotion of the new GMP certification and the approaching of the big limit, the industry believes that the pharmaceutical industry, especially the traditional Chinese medicine enterprises, may usher in the opportunity of reshuffle Shi lichen said that because of the bad phenomenon of "bad currency expelling good currency" in the traditional Chinese medicine industry, many small pharmaceutical enterprises have been seizing the market by means of counterfeiting, shoddy and other means to reduce the cost price, leading to big enterprises being helpless in the face of bad competition, and also causing market chaos Now through high-density "flight inspection" and confiscation of GMP certificates, it helps to expel these "black sheep" In addition, schlichen specially pointed out that while the GMP certificate was confiscated, more enterprises simply abandoned themselves and waited for "closing the door for good", "due to the fierce market competition, some small enterprises and small pharmaceutical factories could not meet the requirements of the new GMP certificate, so they simply waited for the certificate to expire at the end of this year, stopped the product line and transformed to other fields".
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