污染控制-仍然是检查中的问题

一沙一叶

Measures for contamination control are one of the basic requirements for the manufacturing of medicinal products. Manufacturing of pharmaceuticals warrants a dedicated and valid system to avoid contamination as well as a clear disaster strategy to handle microbiological deviations.
污染控制措施是医药产品生产的一项基本要求.医药产品要求要有专门有效的系统来防止污染,同时还要有清楚的灾难策略来处理微生物偏差。
Preventive measures like suitable rooms, ventilation and equipment and a validated cleaning and disinfectant process for these rooms and the equipment are the first part of such a system. The second part are controlling measures like environmental monitoring, IPC and last but not least the handling of deviations and the following CAPA. Normally we should expect that these should be well known by the manufacturers and their responsible employers.
预防措施，像适当的房间、通风和设备以及用于这些房间和设备的经过验证的清洁、消毒程序是这个系统最重要的部分。第二部分是控制措施，像环境监控、IPC、最后但是不是最少的，偏差的处理以及随后的CAPA。通常情况下，我们希望生产商和岗位上的员工能够清楚这些内容。
Previous inspection reports of the responsible authorities demonstrate this: between 1995 and 2005, the potential risk of microbiological contamination was the No 2 Critical GMP Deficiency and the No 1 Major GMP Deficiency observed during inspections ordered by CHMP/CVMP. A detailed analysis of the annually published FDA Inspectional Observation Summaries (483s) also showed that issues like hygiene, cleaning and disinfecting were still frequent reasons of deviations. More than 120 entries in the FY 2010 Inspectional Observation Summaries clearly demonstrate this.
责任当局以往的检查报告证明了以下内容：在1995和2005之间，由CHMP/CVMP进行的检查结果中，微生物污染的潜在风险在严重GMP缺陷中排名第二，在主要缺陷中排名 。每年颁布的FDA的检查结果摘要（483）的详细分析也表明，像卫生、清洁和消毒的问题仍然是偏差常见的原因。2010年检查结果摘要中120多项内容清晰的证明了这一点。
In the following years, the analysis of the FDA Warning Letters indicated that the situation had improved. In 2013 section 211.113 of the Code of Federal Regulations (CFR) did not show any respective citations in the top 10 of the ranking list of the most frequent GMP deviations. Expectations that this development would go on showed to be wrong, though.
在随后几年，对于FDA警告信的分析表明形势有所改善。2013年，在最常见的GMP偏差的前10名列表中CFR的211.113项内容并没有被引用。尽管，对于这个发展能够持续下去的期望最后没有实现。
An analysis of the FDA Warning Letters of Fiscal Year 2014 shows that the No. 1 of 21 CFR 211 Citations - Top Ten List of Finished Pharmaceuticals is topic § 211.113 - Control of microbiological contamination. Additionally, as No.8 on the Top Ten List you can find § 211.67 - Equipment cleaning and maintenance and, as No.9 § 211.56 - Sanitation.
对于2014年的警告信的分析表明，医药成品的排名前10名的缺陷中引用最多的是211.113-微生物污染的控制。另外，前10名列表中第8名可以找到211.67-设备清洁和维护，第9名是211.56-环境卫生。


ECA新闻
http://www.gmp-compliance.org/en ... ng-inspections.html

sheepcrane

学习一下哈

nf-sz

哦 医药产品生产微生物污染控制 确实是一个问题

linqiju

好想有一些培训，告诉我们怎么具体去做，而不是提要求和要效果

Evanxu

学习学习。。。。。。。