GMP-shaped in the form of 13 Chinese herbal pieces factory production and rectification

Zhong has all been included in the National Basic medicines Catalogue of Chinese herbal pieces, is becoming the subject of intensified supervision by the regulatory authorities. June 15, Guangzhou of Food and Drug Administration (hereinafter referred to as "Guangzhou Food and Drug Administration") in the "three dozen two build" special activities revealed, since 2011, Guangzhou has strengthened the supervision of Chinese herbal medicine market and the quality of Chinese herbal pieces, and so far last year, 10 Chinese herbal pieces of Guangzhou enterprises have been retracted for violating relevant regulations.　　Pharmaceutical Production Quality Management code (hereinafter referred to as "GMP") certificate.　　and "The first financial daily (micro-blog)" Inquiry Guangdong Food and Drug Administration (hereinafter referred to as "Guangdong Food and Drug Administration") official website found that from the second half of last year to the beginning of June this year, the province has 13 pieces of Chinese herbal medicine production enterprises because of illegal regulations by the Guangdong Food and　　According to our understanding, in the traditional Chinese medicine industry norms in the production process, plant and animal medicine for raw materials, processed as a standardized processing of Chinese herbal pieces, Chinese herbal pieces can be directly used in Chinese medicine prescriptions, but also the main raw materials of Chinese medicine.　　Data show that Guangzhou a total of 45 Chinese herbal pieces of production enterprises, and last year, there have been 10 of the recovery of GMP certificate cut-off rectification, illegal enterprises accounted for up to 22%. Guangzhou Food and Drug Bureau deputy director Lin Yongxie told this newspaper, although the production of Chinese herbal pieces GMP compulsory certification, but compared with the preparation of production enterprises, traditional Chinese medicine pieces production enterprises generally have a low level of production quality management, not according to the legal processing methods for production or even purchased pieces of the packaging,　　Not strictly in accordance with quality standards of pieces of finished products to implement batch testing and other phenomena occur. "In particular, some of the Chinese herbal pieces factory, although has passed GMP certification, but there are many varieties through the processing of OEM, we can not determine whether the processing of these generations in line with the GMP requirements of the environmental production, but also may be in a very messy environment for processing, Therefore, we recommend the provincial Drug Administration to recover the GMP certificate.　　Lin Yong Sheng said.　　A person familiar with the drug Administration of the industry told this newspaper, the drug regulatory department to recover the GMP certificate, pharmaceutical enterprises can not produce, generally to stop the rectification of three months to six years to regain the certificate.　　May 2011, there is the industry "general Medicine King" of Sichuan Shu China Pharmaceutical Co., Ltd., which is due to irregularities in the production workshop of Sichuan Provincial Drug Administration to recover the GMP certificate, six months after the more than 6 million fine before the resumption of production. The state Food and Drug Administration (hereinafter referred to as "state Food and Drug Administration") in 2004 to implement GMP certification of Chinese herbal pieces, requiring all production enterprises from January 1, 2008 onwards must be in line with the GMP conditions of production.　　As of last September, there are still 200 pieces of plants have not yet passed GMP certification. According to a Guangzhou piece industry personage discloses, the piece factory must pass the GMP attestation, the one-time hardware and the software investment generally is above 10 million yuan, the daily operation cost is also not low, the slice in passes the GMP attestation and does not pass the GMP Attestation Workshop production, the cost has several times difference, only then causes some enterpriseRisk, the use of large varieties in line with the standard production and most of the small variety of processing to reduce production costs. "Many pieces of processing or even in the small workshop in the family, resulting in the production of pieces of GMP certification. At present, the processing industry of Chinese herbal pieces is still small, small enterprises, quality is uneven.　　On the scale of only sig pharmaceutical (600518.SH), has been the Sichuan new Lotus Herbal Pieces Co., Ltd. (hereinafter called "New Lotus") will be landing gem. The competition of Chinese herbal pieces depends on the scale, not the high margin industry.　　This, from pure Chinese herbal pieces company new Lotus can glimpse. The new Lotus prospectus shows that from 2008 to the first half of 2011, the overall gross profit margin of the new Lotus was 16.74%, 20.81%, 22.03% and 22.1% respectively.　　And because there are proprietary Chinese medicine, health products and western medicine and other plates, SIG pharmaceutical industry's comprehensive gross profit margin to be higher, the same period is 26.9%, 33.4%, 36.5% and 30.25%.　　The new edition of "Pharmaceutical production quality Management Norms" (new version of GMP) March 1, 2011 from the formal implementation, according to the state Food and Drug Administration timetable, pieces of production enterprises should be in 2015 to meet the new version of GMP requirements, and the software part of the work should be completed within three years.　　Compared to the old version of GMP, the new version of GMP requirements for software management, only for the production of traditional Chinese medicine from raw materials to finished product testing, you need to invest hundreds of thousands of of the testing equipment, and at present, only some of the size of pieces of enterprises have strict raw materials and finished product testing system. In fact, in recent years, the Chinese medicine industry has been concerned about the overall quality of Chinese medicine because of the lack of relevant quality standards, production links, low limit or even ultra-low limit feeding.