GMP认证 中药饮片加工乱象 虽然有了GMP标准,但是中药饮片加工缺乏统一监管标准 发布时间: 2015-02-09 10:31

GMP认证 中药饮片加工乱象 虽然有了GMP标准,但是中药饮片加工缺乏统一监管标准
GMP certification of Chinese Herbal Pieces processing chaos while the GMP standard, but the lack of a unified regulatory standards of Chinese Herbal Pieces processing
在过去的一年里,食药总局曾于2014年5月、11月二度公开《药品飞行检查办法(征求意见稿)》,针对问题药企药品进行飞行检查。而在去年九月底,国家食品药品监督管理总局发布的“中药材及饮片专项抽验”不合格名单中,93批次不合格产品赫然在列。
In the past year, the food and drug administration was in 2014 May, November two public "drug flight inspection methods (Draft)", flight check to solve the problem of pharmaceutical drugs. In September of last year, the State Administration of food and Drug Administration issued the "Chinese herbal medicine and herbal pieces of special testing" unqualified list, 93 batches of substandard products is in awesomely row.
据初步统计,这些不合格中药饮片主要涉及的问题为无生产资质厂家非法生产和分装中药饮片、人为染色增重、采用硫磺熏蒸加工饮片以及掺杂销售等。
According to preliminary statistics, these unqualified Chinese herbal medicine mainly deals with the problem of no production qualification manufacturers illegal production and packing of Chinese herbal pieces, artificial dyeing weight gain, using sulfur fumigation processing pieces and doping sales etc..
“相关部门近期严抓中药饮片加工厂家,主要因为目前没有专门针对中药饮片的管理规范,而是推行新版药品GMP,规范中药饮片企业生产加工行为。前三年GMP是适应阶段,这两年则是强制执行阶段。”卓创资讯中药分析师向中鸿企业管理咨询公司说道。
"Relevant departments recently strict factory processing of traditional Chinese medicine, mainly because at present no specific management standardization of herbal pieces, but the implementation of new edition GMP, production and processing of Chinese herbal medicine enterprise behavior norms. Three years ago GMP was adapted to the stage, these two years is the enforcement stage." Zhuo and information analysts to traditional Chinese medicine in Hong enterprise management consulting company said.
根据《药品生产质量管理规范2010年版》认证要求,中药饮片生产企业要在2015年12月31日前,必须通过国家新版GMP认证,否则不得继续生产。根据国家食品药品监督管理总局的统计数据,截至2013年12月,我国取得中药饮片GMP资格认证的企业有1580家。而由于质量问题频发,不少企业被收回了GMP证书。截至2014年10月,这一数据骤减至927家。
According to "drug production quality management specification 2010 Edition" certification requirements, Chinese herbal medicine production enterprises in 2015 before 31 December, must pass the national version of GMP certification, or not to continue the production. According to the statistics of the State Administration of food and drug supervision and management, as of 2013 December, China obtained the Chinese herbal medicine GMP certification enterprises 1580. Due to frequent quality problems, many enterprises is to recover the GMP certificate. As of 2014 October, this data to drop to 927.
知情人进一步透露:“虽然有了GMP标准,但是中药饮片加工缺乏统一监管标准,主要是靠自查或者相关部门监察。现在饮片加工乱象很多,有的厂家缺乏某一环节的加工资质,所以他们把触角伸向这一环节。也有的厂家把GMP的资质牌照发给小厂,让他们用自己的土办法加工,这样子盈利比较快也节约成本,也是业内的一个普遍的现象。”
Insider revealed further: "although the GMP standard, but the Chinese herbal medicine processing the lack of a unified regulatory standards, mainly by self-examination or related departments supervision. Now many pieces processing chaos, some manufacturers lack of processing the qualification of a chain, so their tentacles into this link. Some manufacturers of the GMP qualification license issued to small factory, let them process with its own soil, so the profit faster and save cost, a common phenomenon is the industry."
资料显示,中药饮片的加工需要经过原药材准备、挑选整理、浸润漂洗、生片切制、烘干、炮炙加工、包装等流程。由于产地、自然条件等不同,同一种类中药材的品质存在很大差异,价格相差几倍甚至十几倍。
The data shows, the processing of traditional Chinese medicine have been the original medicinal preparation, selection of finishing, infiltration, slice for rinsing, drying, roasting and broiling processing, packaging process. As a result of habitat, the natural condition and different, there is a big difference in the same kind of medicinal material quality, the price difference is several times or even several times.
加上加工过程中的炮制技术不同,进一步增加了加工后的中药饮片等级差别。比如,用硫磺熏蒸等土方法加工而成的饮片,片型整齐美观、售价低、不易蛀虫,就深受消费者青睐。
Process plus in different processing technology, to further increase the difference after the processing of Chinese medicine Yinpian grade. For example, for processing sulfur fumigation soil method into pieces, pieces of type appearance, low price, easy borer, is favored by consumers.
中鸿认证咨询了解到,以前中药饮片厂房设备没有进行现代化改造,机械设备的投入资本不高,所以成本低。如今,中药饮片企业要取得GMP资质,必须按照统一的标准来进行厂房改造,重金购置设备机械化生产,每天的生产成本提高。
Zhonghong certification advisory learned before, Chinese Herbal Pieces workshop equipment without the modernization of machinery and equipment, capital investment is not high, so the cost is low. Nowadays, Chinese medicine Yinpian enterprise must obtain the GMP qualification, must be in accordance with the unified standard for plant transformation, a large investment in equipment and machinery production, daily production cost increase.
不过,目前市场上的饮片不分等级和质量好坏,全部混合统装,质量好的饮片难露头角。因而机械化生产的饮片企业,因生产成本高于小作坊,反而在价格上没有竞争优势。
However, the current market pieces regardless of grade and quality, all mixed bulk, good quality pieces to mark. Thus the mechanized production pieces enterprises, due to the cost of production is higher than that of small workshops, but the price is not competitive advantage.