20150408 ECA新闻：德国公布无菌生产商新ZLG备忘

20150408 ECA新闻：德国公布无菌生产商新ZLG备忘

GMP News
08/04/2015

New ZLG-Aide Mémoire for the supervision of sterile manufacturers

无菌生产商新ZLG备忘

The ZLG in Germany (Central Authority of the German Federal L?nder for Health Protection Regarding Medicinal Products and Medical Devices) expert group 3 has published a new Aide Mémoire (AiM) recently that provides inspectors in Germany with a guideline for the GMP supervision of sterile manufacturers. It can be compared to the FDA "Guides to Inspection". The Aide Mémoire now available complements the AiM "Supervision of manufacturers of medicinal products" with specific requirements for the manufacturers of sterile/aseptically produced medicinal products. The division into chapters and numbering corresponds to the structure of Annex 1. The AiM is interesting also for pharmaceutical manufacturers as it gives information on the authorities' expectations in GMP inspections concerning the state of the art and on the areas in which questions have to be expected.

德国专家组3的ZLG刚公布了一份新的备忘，为德国检查无菌生产商的GMP提供指南。它可以与FDA“检查指南”相比美。该备忘现在可以获得，它是对“药品生产商监管”关于无菌生产药品的生产商特定要求的补充。其章节和编号对应于附录1的结构。药品生产企业也对此备忘感兴趣，因为它为企业提供了关于药监对GMP检查中理想状态的期望，以及预计会被问到的问题。

In many parts the AiM is much more detailed than the underlying Annex 1. This is especially remarkable in the chapter on the classification, qualification and re-qualification of clean rooms. Whereas Annex 1 only refers to the EN/ISO 14644 series (sheets 1-4) the AiM contains concrete requirements and instructions. For example, it lists the test parameters expected in a qualification:

该备忘在很多方面都比附录1的内容更详细，特别是在洁净区分级、确认和再确认方面。而附录1只是引用了EN/ISO14644系列（1-4页），而备忘则包括了详细的要求和指示。例如，它列出了在确认中期望的测试参数：

Tightness and leakage in ventilation ducts  通风管道的密封性和泄漏 Measurement of the high and low pressure in the clean room  洁净区的高压和低压测量 Determination of the number of air exchanges  换气次数检测 Leakage tests of the incorporated terminal filters  安装后终端过滤器泄漏测试 Flow direction and flow velocity measurement in rooms with TMF  有TMF的房间里的气流方向和气流速度测度 Measurement of recovery times in rooms with LTF  有LTF的房间里的自净时间测量 Determination of the clean room class  洁净区级别的决定 Smoke studies for the visualization of the flow conditions   气流条件目视烟雾测试 Temperature  温度 Humidity
• 湿度
  

Even the points expected in the measurement report of the particle test are listed individually. The extent of testing for the re-qualification as well as the expected frequencies are also described. Basis is again the 14644 series (including the annex!) but also the PIC/S-document PI 032-2 which also interpretes the requirements of Annex 1 more closely.

在粒子报告中甚至分别列出了期望测试的点，还描述了所期望的再确认频次及再确认测试的程度。所基于的标准还是14644系列（包括附录1），但也包括了PIC/S文件PI021-2，其中还更详尽地解释了附录1的要求。

Chapter 20 (Alert and action limits for particle and bacterial count) is another example. Annex 1 only talks about "appropriate limits". The AiM on the other hand gives concrete information for example on the standard deviation for particle measurement and it contains formulas for the limits of bacterial counts without normal distribution.

第20章（粒子和微生物计数警戒限和行动限）是另一个例子。附录1只是讲到了“适当的限度”，而备忘中则给出了具体的粒子测量标准偏差例子信息，还包括非正态分布细菌计数限度公式。

Another example is chapter 37 (Training). Here, Annex 1 only talks about a regular training in the correct manufacture of sterile medicinal products of the personnel employed in clean areas. The AiM however, is much more concrete and requires for personnel in Grade A and Grade B zones a triple successful entering of clean rooms under supervision including a microbiological monitoring of the personnel. Additionally it is expected that a re-qualification of the process of entering a clean room is carried out at least once a year.

另一个例子是第37章（培训）。这里，附录1只讲到了洁净区内人员无菌药品生产正确操作的常规培训，而备忘则更具体地要求A级和B级人员在监督下三次成功进入清净区，包括人员微生物监测。另外，还期望至少一年要对进入洁净区的程序进行再确认。

Please see the (only in German language available) document "?berwachung von Steril-Herstellern" for further information.

更多信息参见上述网址（仅德文）。转载自2015-04-13 00:07:28|  分类： ECA新闻

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