近日，随着全国首例特大地沟油案的审理，许多制药企业被爆使用“勾兑豆油”生产头孢菌素关键性中间体——7-ACA。3日，省食药监局下发通知，要求加强对药品生产用油脂类原料质量的监管，严防不合格油脂类原料进入制药环节。

recently,As the country's first jumbo trench oil case trial,Many pharmaceutical enterprise is critical to use"Blending soybean oil"Production cephalosporins key intermediates - 7 - ACA.Three days,Provincial food's drug watchdog issued a notice,Requirements of pharmaceutical production to strengthen the quality of raw material with oil kind of supervision,Take strict precautions against unqualified grease class raw material into the pharmaceutical link.

　　近日，随着全国首例特大地沟油案的审理，许多制药企业被爆使用“勾兑豆油”生产头孢菌素关键性中间体——7-ACA。3日，省食药监局下发通知，要求加强对药品生产用油脂类原料质量的监管，严防不合格油脂类原料进入制药环节。

recently,As the country's first jumbo trench oil case trial,Many pharmaceutical enterprise is critical to use"Blending soybean oil"Production cephalosporins key intermediates - 7 - ACA.Three days,Provincial food's drug watchdog issued a notice,Requirements of pharmaceutical production to strengthen the quality of raw material with oil kind of supervision,Take strict precautions against unqualified grease class raw material into the pharmaceutical link.

　　8月末，齐鲁制药、健康元、正大集团下属公司等药企被爆使用含地沟油的“勾兑豆油”制药。报道称，由地沟油勾兑而成的豆油被用来生产头孢菌素关键性中间体——7-ACA。7-ACA是用于生产头孢类抗生素的中间体，属于化工原料。

Late August,Qilu pharmaceutical/Health yuan/Zhengda group affiliated companies, such as medicine to be critical to use contain trench oil"Blending soybean oil"pharmaceutical.Reports say,The trench oil blending in soybean oil was used to produce cephalosporins key intermediates - 7 - ACA.7 - ACA is used in the production of cephalosporin antibiotic intermediates,Belongs to the chemical raw materials.

　　为加强对药品生产用油脂类原料的质量控制，省食药监局下发通知要求，各地加强对药企油脂类原料的监管。省食药监局要求，药品生产企业必须按规定对所购油脂类原料严格把关，要严格供应商管理，供应商的确定及变更应当进行质量评估，经质量管理部门批准后方可采购，供应商应资质齐全、质量可靠、信誉良好。药品生产企业应与供应商签订质量保证协议，并按照国家标准进行检测，严防不合格油脂类原料进入制药环节。

To strengthen the pharmaceutical production with grease kind of raw material quality control,Provincial food's drug watchdog issued a notice requirements,Strengthen enterprises to medicine oil kind of raw material supervision.Save food, the administration's requirements,Pharmaceutical producing enterprises must follow a prescribed to buy oil kind of raw material strictly,To strict supplier management,The determination of suppliers and alteration shall conduct quality evaluation,The quality management department approval to purchase,The supplier should complete qualifications/Reliable quality/Good reputation.Pharmaceutical producing enterprises shall be signed with the supplier quality assurance agreement,According to the national standard and testing,Take strict precautions against unqualified grease class raw material into the pharmaceutical link.

　　对于外购7-ACA生产头孢类抗生素的药品生产企业，省食药监局要求，其加强供应商质量审计，必要时，应进行现场质量审计。药品生产企业应完善7-ACA类医药中间体质量标准，严格原料的检验管理，严防不合格原料流入生产环节。药品生产企业要加强对油脂类原料的质量控制，对所购原料严格按国家标准进行检验，经检验合格后方可投产使用。

For purchased 7 - ACA production cephalosporin antibiotic pharmaceutical production enterprise,Save food, the administration's requirements,To strengthen the supplier quality audit,When necessary,Should undertake the field quality audit.Pharmaceutical producing enterprises should improve 7 - ACA kind of pharmaceutical intermediates quality standards,Strict raw material inspection management,Take strict precautions against the unqualified raw materials into the production links.Pharmaceutical producing enterprises to strengthen the grease kind of raw material quality control,To purchase raw materials in strict accordance with the national standard for inspection,After passing test rear can put to use.

　　药品生产企业应严格按照注册批准的工艺组织生产，不得擅自变更生产用油脂类原料，要切实加强药品生产过程的质量监测和控制，确保药品生产质量安全。 (记者 李钢)

Pharmaceutical producing enterprises shall be in strict accordance with the approval of the registration process of production organization,Shall not unilaterally modify production with grease kind of raw material,To strengthen the quality of pharmaceutical production process monitoring and control,To ensure the quality and safety of drug production. (Reporter LiGang)