Notice on strengthening the supervision and management of Chinese herbal extracts

To the Municipal Drug Administration: In order to further strengthen the supervision and management of traditional Chinese medicine extracts, standardize the entrusted processing behavior of traditional Chinese medicine extracts of enterprises, and ensure the quality of traditional Chinese medicine products, according to the notice on strengthening the supervision and management of pretreatment and extraction of traditional Chinese medicine (gjja [2002] No 84) issued by the State Drug Administration and the notice on relevant provisions on entrusted processing of traditional Chinese medicine extracts issued by the Provincial Bureau (wfjja [2003 ]No 209) spirit, we hereby reiterate and put forward the following opinions on the supervision and management of traditional Chinese medicine extracts All municipal bureaus are requested to inform all relevant pharmaceutical manufacturers within their jurisdiction in a timely manner and earnestly implement them First, pretreatment and extraction of traditional Chinese medicine is an important process in the production process of traditional Chinese medicine, and also a key link to ensure the quality of traditional Chinese medicine In the process of GMP transformation, each TCM manufacturer should set up TCM pretreatment and extraction workshop according to the process requirements 2 With the approval of the provincial food and drug administration, the traditional Chinese medicine manufacturer may temporarily not build a pre-treatment and extraction workshop in the plant area under the following circumstances, and adopt the following methods for pre-treatment and extraction of traditional Chinese medicine: 1 Due to environmental protection and other factors, if the factory can not establish a pretreatment and extraction workshop, the pretreatment and extraction workshop (branch factory) can be established in another place within the province with the consent of the Provincial Bureau; 2 With the approval of the Provincial Bureau, the same group of internal Chinese medicine manufacturers can share a pretreatment and extraction workshop, which should belong to a production enterprise within the group; 3 Enterprises that have not yet built a workshop for pre-treatment and extraction of traditional Chinese medicine may, with the approval of the Provincial Bureau, entrust other enterprises with GMP certificates for pre-treatment and extraction of traditional Chinese medicine 3 The enterprises that establish the pre-treatment and extraction workshop of traditional Chinese medicine in different places, share the pre-treatment and extraction workshop within the group and entrust GMP certification enterprises to process the extracts of traditional Chinese medicine must establish a practical quality assurance system and management measures, establish strict quality control standards for extracts, and take effective measures in the transportation process to ensure the quality of extracts IV the entrusting party entrusted with the processing of traditional Chinese medicine extracts shall provide the controllable quality standards, technological procedures and other necessary technical documents During the entrusted processing, the entrusting party shall send quality and technical personnel to carry out quality monitoring and technical guidance in the whole production process The batch production records and inspection records of Chinese medicine extraction shall be kept by the entrusting party and the entrusted party for three years respectively as required During GMP certification inspection, the entrusting enterprise shall submit corresponding technical documents of Chinese medicine extraction, batch production records and inspection records for future reference 5 The following application materials shall be submitted for the entrusted processing of Chinese herbal extracts: 1 The application form for entrusted processing of Chinese herbal extracts (see the attached table) jointly filled in by the entrusting party; 2 The copy of the license for pharmaceutical production enterprises of the entrusting party; 3 The copy of the GMP certificate of the entrusted processing enterprise; 4 Production approval documents of entrusted processing of traditional Chinese medicine products; 5 Technical procedures for pretreatment and extraction of traditional Chinese medicine, quality standards of traditional Chinese medicine extract; 5 Processing contract (copy) of both parties 6 If the entrusted processing period expires and the entrusted processing must be postponed, in addition to the above information, the batch, output and quality of the processed Chinese herbal extracts during the entrusted processing shall also be provided The Provincial Bureau will approve the application in the form of approval, and send a copy to the local drug administration of the entrusted parties 6 The legal responsibility for drug quality shall be borne by the entrusting party The entrusting party shall file with the Provincial Bureau for the cancellation of the entrusted processing relationship of Chinese herbal extracts 7 The extraction of sterile preparations of traditional Chinese medicine shall not be commissioned for processing Enterprises that have obtained GMP certificates and have no conditions for the extraction and production of traditional Chinese medicine sterile preparations should pay close attention to the rectification and put it in place before December 31, 2004 8 The Municipal Drug Administration shall strengthen the supervision and management of the pre-treatment and extraction of traditional Chinese medicine in the production enterprises of traditional Chinese medicine, supervise and inspect the enterprises that have passed the GMP certification and the enterprises that have approved the entrusted processing of traditional Chinese medicine extracts If the entrusted processing is entrusted or accepted without approval, and the entrusted processing is conducted beyond the approval period, the traditional Chinese medicine extracts are not in accordance with the process and standards In case of production, it shall be ordered to make rectification within a time limit and be punished according to relevant regulations, and shall be reported to the safety supervision department of the Provincial Bureau If there are any problems and suggestions in the implementation of this article, please timely feed back to the safety supervision office of the Provincial Bureau Attachment: 1 Application form for entrusted processing of traditional Chinese medicine extract 2 Enterprises approved for entrusted processing of traditional Chinese medicine extract 2 Enterprises approved for entrusted processing of traditional Chinese medicine extract 1 Anhui Dongfang lingzhibao Pharmaceutical Co., Ltd entrusted Huatuo national pharmaceutical factory to process Banlangen extract (2003, 3-2003, 12) 2 Anhui Bangning Pharmaceutical Co., Ltd entrusts huatuoguo pharmaceutical factory to process extracts such as Radix Isatidis extract (2002, 11-2003, 12) 3 Hefei shenlu Shuanghe Pharmaceutical Co., Ltd entrusts Jiuhua pharmaceutical industry processing, an enterprise within the group 4 Anhui yongshengtang Pharmaceutical Co., Ltd entrusts huatuoguo pharmaceutical factory to process Radix Isatidis extract (2002, 8-2004, 8) 5 Xinli pharmaceutical Ma'anshan branch entrusts Bengbu Tushan branch to process Chinese herbal extracts 6 Hefei shenlu Shuanghe Pharmaceutical Co., Ltd entrusts huatuoguo pharmaceutical factory to process Danshen Extract (August 2003 to June 2004) 7 Anhui Dongfang lingzhibao pharmaceutical company entrusts huatuoguo pharmaceutical to process ganoderma extract (October 2003 to October 2004) 8 Anhui yongshengtang Pharmaceutical Co., Ltd entrusts huatuoguo pharmaceutical factory to process Niuhuang Jiedu tablet extract (November 2003 to October 2005) 9 Fuyang Jinma Pharmaceutical Co., Ltd entrusts huatuoguo pharmaceutical factory to process musk bone strengthening extract and musk analgesic patch extract (December 2003 to November 2004) 10 Hefei cube Pharmaceutical Co., Ltd entrusts Jingfang Pharmaceutical Co., Ltd to process the extract of Banlangen (December 2003 to November 2004) 11 Huainan Jiameng Pharmaceutical Co., Ltd entrusts Anhui Huatuo state pharmaceutical factory to process the extract of Banlangen, the dry extract powder of Apocynum venetum, the dry extract powder of Chrysanthemum indicum, the dry extract powder of anti dried and the flowing extract of belladonna (December 2003 to December 2004) 12 Anhui golden sun Pharmaceutical Co., Ltd entrusted Jiufang pharmaceutical company with Siwei extract of Niuhuang Jiedu tablet (December 2003 to December 2004) 13 Danshen Extract group of Anhui Huayuan Pharmaceutical Co., Ltd shared (Shanghai No.1 biochemical) (from April 2004 to April 2005) 14 Anhui new synthesis Wannan Pharmaceutical Co., Ltd entrusts Anhui huatuoguo pharmaceutical factory to process liquorice liquid extract, Platycodon liquid extract, orange peel tincture, Banlangen extract and Qiangli loquat extract (April 2004 to December 2004) 15 Anhui Guozheng Pharmaceutical Co., Ltd entrusted Anhui Huatuo state pharmaceutical factory to process the Banlangen extract (April 2004 to April 2005) 16 Wuhu Boying Pharmaceutical Co., Ltd entrusted Zhang Hengchun (May 2004 to April 2005) 17 Anhui ankehengyi Pharmaceutical Co., Ltd has the following extracts: (1) Pinellia ternate supernatant, ephedra, Platycodon and other extracts; (2) liquorice extract, Platycodon grandiflorum extract, orange peel tincture; (3) Fritillaria chuanbeiliu extract, Platycodon grandiflorum and loquat leaf concentrate; (4) Banlangen thick extract; (5) Coptis Coptis Shangqing tablet clear extract; (6) motherwort clear extract; (7) Fuganning tablet thick extract; (8) Schisandra Schisandra flow extract Entrusting Jiufang pharmaceutical company (May 2004 to December 2004) 18, Anhui ankehengyi Pharmaceutical Co., Ltd loquat leaf, Baibu and other concentrated solutions to entrust Huoshan Pharmaceutical Co., Ltd of Hangzhou huiyinbi group for processing (May 2004 to December 2004) 19 Anhui Bangning Pharmaceutical Co., Ltd entrusts Huangshan Tianmu Pharmaceutical Co., Ltd with liquorice liquid extract, Platycodon grandiflorum liquid extract, chuanbeiliu extract, Platycodon grandiflorum, loquat leaf liquid extract, fresh sedge, dwarf tea extract, Banlangen extract, seven star tea extract for children (June 2004 to December 2004)