ECA新闻20150506：污染控制---仍然是药品检查中的问题

ECA新闻20150506：污染控制---仍然是药品检查中的问题  2015-05-08 12:45:34|  分类： ECA新闻

GMP News
06/05/2015

Contamination Control - Still an issue during inspections

污染控制---仍然是药品检查中的问题

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.

污染控制的措施是药品生产基本要求之一。药品生产保证有一个专用的有效系统来避免污染，并有明确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.

预防措施如适当的房间布置、排分和设备，以及验证过的对这些房间和设备的清洁和消毒工艺，是这样系统的第一部分。第二部分是控制措施，如环境监控、IPC和，最后但也很重要的一点，偏差的处理和CAPA的跟踪。一般来说，我们应当期望生产商和其负责的员工都要知道这些。

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.

之前有关药监部门的检查报告证明，在1995年到2005年间，CHMP/CVMP所排序的检查其是发现的GMP缺陷中，潜在微生物污染风险排在关键缺陷的第2位，主要缺陷的第1位。FDA发布的年度检查缺陷汇总（483缺陷）详细分析中也显示一些问题如卫生、清洁和消毒仍是偏差的常见原因。在2010财年检查缺陷汇总中，超过120条清楚证明了上述说法。

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.

在之后几年，对FDA警告信的分析显示情况有所好转。在2013年，前十位最常见GMP问题中并未出现对CFR第211.113节的引用。但期望这种情形会延续显然是错的。

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FDA在2014财年的警告信分析显示，在21CFR211条款中被引用最多（制剂前十缺陷清单）的是第211.113节---微生物污染控制。另外，前十位的第8位是第211.67节---设备清洁和维护，经9位为第211.56节---消毒。