EMA公布一封巴西的无菌药品工厂的缺陷报告

一沙一叶

欧盟公布了一封巴西的无菌药品工厂的缺陷报告EudraGMDP数据库是欧盟建立的会公布欧盟药监部门的检查报告。这些报告涉及到欧盟内部和外部的检查。这些报告是由各国当局部门通过标准表格输入到系统中的。对于涉及到的公司，一封不合格报告可能产生严重的后果直到改正。可能终止上市许可，召回问题产品，还有别的行动。
意大利药监部门对巴西这家工厂进行了检查。发现了四个严重缺陷和七个重要缺陷。作为后续结果，药监禁止这个场地生产的所有产品供应，并且中止了CEP证书。
严重缺陷

• 报告批评了维护和清洁的水平不足。而且，报告批评了人员资质不足，他们缺少对GMP的理解，并且几乎没有监督。直到近期检察官进入了D级和C级洁净区，不被允许的和欺骗的行为才被阻止。
• 没有按照EU GMP指南附录A的要求进行环境监控（结晶在B级洁净区），也没有执行其他的环境控制措施。
• 制造商没有执行一个有效地药品质量管理系统。只有部分程序被遵守，没有调查、风险评估、说明或者适当记录进一步的措施；
• 文档资料不能够追踪各类行为操作。
  

重大缺陷
  有时候，给出了不一致的答案，并且一些员工没有能力给出正确的答案或者展示正确的文件；

  在实验室，没有执行有效的政策、程序或者控制来保证分析数据的可信度和完整性；
  微生物室设计的物料流向无法在测试性能的时候阻止潜在的污染
  一些工作直到被发现不充分，因为它们不够具体或者含有错误信息；
  没有执行程序来防止用于分发和取样的房间的污染；
  生产中使用的纯化水和氮气的质量没有被充分的分析和监控。
  培训项目中不包含专门的关于欧盟GMP的培训或者关于巴西和欧盟GMP差异的培训。


EMA Non-Compliance Report for Brazilian Manufacturer of sterile ProductsNon-compliance reports are published in the EudraGMDP database of the European Medicines Agency (EMA) by European supervisory authorities. They refer to inspections inside as well as outside of the European Union. The non-compliance reports are independently submitted into the database by National Competent Authorities via a standardised form. For the company concerned, a non-compliance report has severe consequences until the violations are rectified. Amongst other things, a suspension of the marketing authorisation as well as recalls of the products in question could be mandated.
On January 5th, 2017, the EMA published a non-compliance report on the Brazilian manufacturer of antibiotics Antibioticos do Brasil LTDA in Sao Paulo. The API manufacturer was inspected by the Italian supervisory agency "Italian Medicines Agency". During the inspection, four critical and seven major deficiencies were observed. As a consequence, a prohibition of supply for all products produced at the inspected site was suggested, as well as a suspension of the CEP (Certification of Suitability).
Critical deficiencies:

• An insufficient level of maintenance and cleaning was criticised. Furthermore, the report criticises the inadequate qualification of the personnel, their lack of understanding for GMP, the barely existent supervision of staff members and that non-authorised and fraudulent activities weren't stopped until shortly before the inspectors entered two clean rooms of class D and C;
• Environmental monitoring (crystallisation in clean room class B) wasn't performed in accordance with the principles of Annex A (probably meaning Annex 1) of the EU GMP Guideline, nor were additional environmental controls implemented;
• The manufacturer failed to implement a robust pharmaceutical QM system. Procedures had only been followed in parts and further actions were neither investigated, risk assessed, justified nor appropriately documented;
• The documentation didn't allow for traceability of activities.
  

Major deficiencies:
In some situations, inconsistent answers were given, and some staff members weren't able to give correct answers or show the correct document;

• In the laboratory, there were no robust policies, procedures or controls implemented in order to ensure the reliability and integrity of analytical data;
• The material flow in the microbiological laboratory wasn't designed to prevent a potential contamination risk during the testing performance;
• Some working instructions were found to be inadequate because they were lacking detail or containing false information;
• There were no procedures implemented in order to prevent contamination in a room for dispensing and sampling;
• The quality of the purified water and nitrogen used in production hasn't been sufficiently analysed and monitored;
• The training programme contained no specific training regarding European GMP regulations or training regarding the differences between Brazilian and European GMP regulations.
  

zysx01234

哈哈，翻船了，比起海正稍逊一点

langerdorff

海正应该比这个好点吧