Chinese herbal medicine companies out of the GMP frequency was received
It is understood, Weihai Renji Chinese medicine Yinpian factory, Yantai Guokang Chinese medicine Yinpian Co., Ltd, Shandong Shun students Hall Chinese medicine Yinpian Co., Ltd., three pharmaceutical producing enterprises are serious violations of "drug production quality management standards" provisions, according to "drug production quality management standard certification management approach" the provisions of article 33, Shandong Province food and Drug Administration in accordance with the law to recover the "GMP inspection certificate."
It is reported to be recovered the GMP certificate, including in western medicine producing alternating collinear, fabricating false inspection reports, traditional Chinese medicinal materials of mildew, suspected of producing fake Chinese medicine Yinpian, suspected of OEM production of traditional Chinese medicine Yinpian, suspected of loan package material and its production place etc..
Can not be denied that the Chinese herbal medicine industry ills awaited, market need purification.
October 2015, the State Food and drug administration again in the nationwide organization of phellodendron bark, corydalis tuber, Chinese herbal medicine and traditional Chinese medicine decoction pieces of special supervision and testing, the results detected 9 batches of samples containing auramine O. The chemical coloring agent belongs to non edible substance and has toxic effect.
Forging production records and inspection records, production quality management confusion, material management is not standardized, suspected of lending venues and permits to prove, without the use of special equipment processing toxicity of Chinese herbal medicines...... Facing the strict requirements of GMP, the enterprise of Chinese herbal medicine many irregularities, suddenly appeared. Especially in Anhui, Guangdong and other traditional Chinese medicine Province, Chinese herbal pieces of enterprise collective in the gun".
According to the CFDA data display, from 2014 to recover 50 certificate to 2015 recycling the 147 GMP certificate view, Chinese enterprises accounted for than the maximum, the 2015 Chinese medicine Yinpian enterprise is recovered GMP reached 82, and in 2015 is recycled to the 50 non sterile preparations enterprises, 33 belongs to the medicine production enterprises, with 82 home is syndrome of Chinese medicine Yinpian enterprise, belongs to the Chinese medicine enterprise was close to the total number of card for 115, occupied 78.2% of the total number of cards.
Yu Mingde, President of the China Pharmaceutical Enterprise Management Association, said in an interview: "even if there are 20%-30% companies are eliminated, the market has almost no impact on."
It is understood, Chinese herbal medicine GMP certification inspection of the project a total of 111, of which 18 key projects, production procedures and key process, toxic ingredients production, storage and packaging, Chinese herbal medicine processing standard, production water quality standards, Chinese herbal medicine prior to the release of the record recorded audit were included in the key projects.
It is worth noting that, from January 1, 2016 onwards, the new version of the GMP end of the transition period, while the certification work to the provinces, autonomous regions and municipalities directly under the central government's food and drug administration is responsible for. While flying in various provinces and cities along the storm this year also means that Chinese herbal medicine thepinch enterprise.
Source: China pharmaceutical net