20140702 ECA新闻：EMA数据库中发面新GMP不符合报告

20140702 ECA新闻：EMA数据库中发面新GMP不符合报告

2014-07-10 julia翻译 蒲公英

原文网址：http://www.gmp-compliance.org/en ... EMA%20Database.html

GMP News
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New GMP Non-Compliance Reports in EMA Database

EMA数据库中新的GMP不符合报告

The European Medicines Agency (EMA) has established a database which contains GMP and GDP compliance information. This database is called EudraGMDP. For some time now the EMA has also been publishing GMP and GDP Non-Compliance Reports. Some reports cover API manufacturing sites, others cover manufacturing sites for medicinal products. Products from the concerned manufacturing sites should not be used until the GMP compliance is guaranteed again. If a GDP Non-Compliance report has been issued the organisation is no longer allowed to distribute medicinal products or APIs.

EMA已经建立了一个数据库，其中包括了GMP和GDP符合性信息。该数据库称为EudraGMDP。现在EMA已经在该数据库公布GMP和GDP不符合报告。一些报告是针对原料药生产场所的，另一个则是制剂产品生产场所的。这些生产场所的产品在其GMP符合性得到保障前不得使用。被认为GDP不符合的组织不得再销售制剂或原料药。

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The UK Medicines authority MHRA has issued a GMP Non-Compliance Report for WOCKHARDT LIMITED in AURANGABAD, India. A number of Wockhardt operations have already been under scrutiny by US FDA. The current entry in the EU database refers to a number of critical and major findings.  "A critical deficiency was cited with regard to data integrity of GMP records, entries were seen to be made when personnel were not present on site, documentation was seen that was not completed contemporaneously despite appearing to be completed in this manner. A second critical deficiency was cited regarding potential product contamination. This included the use of inappropriate materials close to product, e.g. asbestos coated PTFE seals for centrifuge manways." In addition major deficiencies e.g. on facility, maintenance, design and qualification have been identified. The MHRA states "There are no current GMP certificates in place for this API facility. A restricted GMP certificate will be issued to permit continued testing of products considered to be medically critical, as determined by the national competent authority. National competent authorities should request marketing authorisation holders to conduct a risk assessment to evaluate the risk to product quality and patients from the issues identified".

英国药监部门MHRA刚签发了对印度AURANGABAD的WOCKHARDT LIMITED公司的GMP不符合性报告。该公司的大量运作情况已受到美国FDA的严密监视。目前在欧盟数据库列出的信息有很多关键和主要缺陷。“引用了一个关于GMP记录数据完整性的关键缺陷，发现有些数据输入时其实人员并不在场，未同步记录。引用的第二个关键缺陷是关于潜在产品污染的。其中包括与产品接近的设备部件所用材质不当，例如离心机人孔使用了石棉包覆的PTFE密封”。此外，还在设施、维保、设计和确认等方面发现了主要缺陷。MHRA声称“该原料药场所没有有效GMP证书。会根据国家药监当局的决定，签发一份有限的GMP证书，允许其继续进行关键医疗产品检测。国家药监当局应要求上市许可持有人进行风险评估，评估上述缺陷所带来给其产品质量和患者的风险”。

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Just recently the MHRA has published a GMP Non-Compliance Report for MOORFIELDS PHARMACEUTICALS in London (UK) which contains a number of Investigational Medicinal Products (IMPs). The report states: "Serious deficiencies related to sterility assurance, sterilisation processes and the Pharmaceutical Quality System have been identified at Moorfields Pharmaceuticals. Concerns implicate all aspects of aseptically prepared and terminally sterilised products. Failures and non-compliances were identified with the approach to qualification and the routine controls of sterilisation. Poor aseptic practices were noted with manufacturing processes. Grade A HEPA filter integrity failures have been noted for some areas. Microbiological environmental monitoring and media simulation programmes were deficient. Media simulation failures have been identified. Serious deficiencies were noted with the Pharmaceutical Quality System. Company Corrective and Preventative actions and remediation, to date, have failed to adequately address all deficiencies and non-compliances. There is currently no evidence of non-sterile product on the market. Most unauthorised medicinal products are small volume short shelf life, and not subject to sterility testing. A supervisory risk assessment has been circulated via rapid alert. "

最近，MHRA公布了一份针对位于英国伦敦的MOORFIELDS PHARMACEUTICALS的GMP不符合性报告，其中包括大量临床前药品（IMPs）。报告声称：“在Moorfields Pharmaceuticals公司发现与无菌保证、灭菌工艺和药品质量体系相关的严重缺陷。缺陷影响到无菌工艺生产和终端灭菌产品的所有方面，发现无菌工艺验证方法和常规控制失效和不符合，注意到无菌生产操作遵守性很差。注意到有些区域A级高效过滤器完整性测试不合格。环境微生物监控和培养基模拟灌装程序有缺陷。发现培养基模拟灌装不合格。注意到药品质量体系有严重缺陷。公司的纠正和预防措施以及弥补手段，截止检查时，仍未能解决所有缺陷和不符合情况。目前在售无菌产品没有无菌证据。大多数未经授权的药品为小容量短货架期产品，不做无菌检测。已经通过快速警示系统传达了监管风险评估”。

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The Italian Agency AIFA has issued a GMP Non-Compliance Report for SIMS Società Italiana Medicinali Scandicci srl located in Reggello, Italy. According to AIFA the inspection at the API manufacturer was unannounced in collaboration with Italian police authorities and Italian custom authorities. AIFA found two unauthorized, not-GMP storage areas (declared as office area) among others used for storage of imported materials from China. Also a not compliant GMP repackaging station was found.

意大利药监局AIFA向位于意大利Reggello的SIMS Società Italiana Medicinali Scandicci srl公司签发了GMP不符合性报告。根据AIFA的报告，其对原料药生产的检查未向意大利药监局和意大利海关当局申报。AIFA发现两个未经授权的非GMP存贮区域（公司声称那是办公室区域），用于存贮从中国进口的物料。还发现了一个不符合GMP的再包装工作站。

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In Malta the competent authority found a wholesale distributor who did not comply with GDP requirements. Moreover, the company was made responsible for trading in falsified medicinal products (not purchased from legal supply chain). The wholesale dealer's license was revoked.

在马尔它，药监当局发现一个批发分销商未遵守GDP要求。并且，公司还在进行假药贸易活动（不是从合法的供应链采购）。该公司的批发商执照被吊销。

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