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新版《药品生产质量管理规范》(药品GMP)于2011年3月1日起正式施行,按照国家食品药品监督管理总局的规定,饮片生产企业应在2015年底前达到新版药品GMP要求。中药饮片生产不同于化药及成药的生产,具有特殊性,应该特殊管理。中药饮片新版GMP认证应如何开展已成为界内关注的话题。目前,部分企业已进行了GMP延续认证,中药饮片企业也遇到了对新版认证的困惑与挑战。
The new edition of “Good Manufacturing Practices for Pharmaceutical Production” (GMP drugs) came into force on March 1, 2011. According to the regulations of the State Food and Drug Administration, the production enterprises should reach the new GMP requirements by the end of 2015. Pieces of Chinese medicine production is different from the production of chemical drugs and medicines, with particularity, should be special management. Chinese Herbal Pieces new GMP certification how to carry out Has become a topic of concern within the community. At present, some enterprises have conducted the GMP continuation certification, Chinese Herbal Medicine companies have also encountered confusion and challenges of the new certification.