【讨论】英国MOORFIELDS PHARMACEUTICALS公司被认定为严重无菌保证缺陷

清歌一曲月如霜

英国的主管机关确认以下内容：
制造商：摩菲制药
网站地址：NILE街34号，伦敦N1 7TP，英国
不符合规定的性质：与无菌保证，灭菌工艺和药品质量体系的严重缺陷已经确定在摩菲药品。担忧牵连的无菌准备和最终灭菌产品的方方面面。故障和违规进行鉴定，以资格的做法和灭菌的日常监控。可怜的无菌做法被注意到的制造工艺。 A级HEPA过滤器的完整性的失败已经注意到部分地区。微生物环境监测和媒体模拟程序有缺陷。媒体模拟故障已经确定。严重的不足之处，指出与药品质量体系。公司纠正和预防行动和整治，到今天为止，都未能充分解决所有的缺陷和违规。
附加说明：国家主管部门应该评估本网站提供的产品的重要性，并制定措施，以确保持续的供应。上市许可持有人务请联络有关国家主管当局，以核实是否他们的产品被认为是医学上的关键，因此，这是不符合性声明的关键药品是指那些在没有可行的替代市场关注及的范围之内已经由国家主管机关或EMA（如适用）。The competent authority of United Kingdom confirms the following:
The manufacturer : MOORFIELDS PHARMACEUTICALS
Site address :        34 NILE STREET, LONDON, N1 7TP, United Kingdom
Nature of non-compliance : 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.
Additional comments : National competent authorities should evaluate the criticality of products supplied from this site and enact measures to ensure continued supply. Marketing authorisation holders are requested to contact the relevant National Competent Authority to verify whether their products are considered medically critical, and are therefore outside the scope of this non-compliance statement Critical medicinal products are those where there is no feasible alternative in the market concerned and have been agreed by the national competent authority or EMA as appropriate.

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{:soso_e127:}得说这个中文翻译失败
这个讨论似乎无线可循，这里只给出了结论性语言，但事件呢？

幻影

机翻作品。

laevo

干脆就别翻译了，弄的软件翻译的就摆上来了。。。英文我们也能看懂的好不好。。。

dapone

这个翻译会成为本贴的关注点……………………字数字数