20140924 ECA新闻：欧盟数据库发布新的GMP不符合性报告

20140924 ECA新闻：欧盟数据库发布新的GMP不符合性报告  

2014-09-24 22:32:25|  分类： ECA新闻|

GMP News
24/09/2014

New GMP Non-Compliance Reports available in EudraGMDP

欧盟数据库发布新的GMP不符合性报告

The British Medicines Authority MHRA has issued a GMP Non-Compliance Report for Yung Shin Pharmaceutical Ind Co Ltd in Taiwan. The company manufactures sterile products. The inspection was triggered by a DCP submission. So far, no product from this site has been marketed in the EU. During the inspection, a lack of GMP control of moist heat sterilisation processes was identified. The wide-ranging problems include both the validation and the technical implementation with regard to the equipment.

英国药监当局MHRA刚签发了对台湾永信（音）药品工业有限公司的GMP不符合性报告。该公司生产无菌药品。检查是由一份DCP申报激活的。到目前为止，该场所尚无产品在欧盟发售。在检查期间，发现公司对湿热灭菌工艺缺乏GMP控制。所发现的更多问题包括了设备方面的验证和技术实施。

Besides, the Spanish Authority has also published a GMP Non-Compliance Report for RENOWN PHARMACEUTICALS PVT. LTD. in India. It was the first inspection of the site which intended to manufacture products for the EU market. The inspection was triggered by a marketing authorisation filed in Ireland. As the batch release should have been performed in Spain, the Spanish Authority was responsible. Critical GMP deficiencies were observed like for example "Defective performance of cleaning", "Inappropriate validation of cleaning procedures", "Failures in line clearance", as well as "Lack of mechanisms to ensure integrity of analytical data". It seems that some data have been changed subsequently. Data integrity problems keep on being identified by EU and FDA in India.

此外，西班牙药监当局也公布了对印度RENOWN PHARMACEUTICALS PVT. LTD的GMP不符合性报告。这是该工厂接受的第一次检查，目的是将其生产的产品销往欧盟市场。检查是由爱尔兰所提交的一份上市许可申报所激发的。由于批放行应该在西班牙签署，西班牙药监当局将对此承担责任。检查中发现了关键GMP缺陷，例如“清洁操作有缺陷”、“清洁程序验证不适当”、“清场不够”以及“缺乏机制来保证分析数据的完整性”。貌似很多数据在之后被篡改了。欧盟和FDA在印度一直发现数据完整性问题。

A GMP Non-Compliance Report has also come from the Bulgarian Authority for VETPROM AD. Here again, finished medicinal products were concerned - particularly those which involve sterile manufacturing. In total, 27 GMP deviations were observed. Among them, 8 have been classified as "major deviations". Basically, from the inspectors' view, the pharmaceutical quality system doesn't appear to be functioning. Among other things, some API manufacturers haven't been audited within the supplier qualification process. Moreover, further deficiencies were found like the methods for the sterility test and the requalification of the sterilisation procedure.

保加利亚药监当局也给VETPROM AD 签发了GMP不符合性报告。这里也是制剂成品的问题----尤其是涉及了无菌生产。总共发现27个GMP缺陷，其中8个被定为“重要缺陷”。检查官的眼光来看，药品质量体系看来基本没有起作用。在其它问题有，在供应商确认过程中，有一些原料药生产商没有接受审计。另外，还发现了更多缺陷如无菌测试方法和灭菌方法再确认。

Source: EMA's EudraGMDP Database

来源：EMA的EudraGMDP数据库。

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