FDA一封警告信看医药厂房设计的缺陷

清风无嗔

FDA一封警告信看医药厂房设计的缺陷


里面列举的问题，值得医药工程设计人员思考。。。


FDA已发出警告信，合同澳大利亚有限的药学服务。公司有三个主要的行为。总结如下：

公司没有对气压，足够的控制设备提供微生物，灰尘，湿度和温度，在适当的生产，加工，包装，或保存药物（21 CFR 211.46（b））。

泡室，胶囊包装，没有维护和控制相对湿度在主包装批记录指定的机构。

本产品工艺设计的研究发现，胶囊对湿度敏感的，在约50%的胶囊具有脆性。

响应表明加湿单元被安装为一体的粗线和资格预计于2013竣工。

反应不足，因为它没有充分调查和地址上的药品已经分发到美国市场的影响。

公司没有建立对每个生产阶段保证药品质量的完成时间的限制（21 CFR 211.111）。

产品批生产记录中不包括包装胶囊的时间限制。

书面程序以保证对湿度敏感产品和定义的行动充分的保护（例如，调查，检疫，排斥）如果泡罩包装操作过程中湿度或时间限制发生偏差不可用以。

科学理论是不提供的湿度探头的当前位置在常规过程湿度监测在包装。

公司未能彻底调查任何不明原因的差异或失败的批处理或其任何组成满足其任何要求，是否有一批已经分布（21 CFR 211.192）。

公司没有主动在包装确定湿度漂移的根本原因的调查。

公司回应说，调查程序是足够的，人员没有按照它。

这种反应被发现有不足之处，因为

它没有解决的事实调查记录的形式，缺乏在调查过程中采取的步骤和足够的细节

未能确定湿度漂移的根本原因并提供适当的纠正和预防措施。

FDA has issued a warning letter to Contract Pharmaceutical Services of Australia Pty. Ltd. There are three major violations. Summary is given below:
Firm failed to provide equipment for adequate control over air pressure, micro-organisms, dust, humidity, and temperature when appropriate for the manufacture, processing, packing, or holding of a drug product (21 CFR 211.46(b)).
Blister rooms where capsules are packaged, had no mechanism to maintain and control the relative humidity as specified in master packaging batch record.
Process design studies on this product found that the capsules are sensitive to humidity and that after approximately 50% of the capsules exhibited brittleness.
Response indicated that humidification unit was installed for one of the blister lines and qualification is expected to be completed in 2013.
Response was inadequate because it did not adequately investigate and address the impact on the drug product already distributed to the U.S. market.
Firm failed to establish time limits for the completion of each phase of production to assure the quality of the drug product (21 CFR 211.111).
Product batch manufacturing records did not include time limits for packing of capsules.
Written procedures to assure adequate protection for humidity-sensitive products and defining actions (e.g., investigation, quarantine, rejection) to take if humidity or time limitation deviations occur during the blister packaging operation are not available.
Scientific rationale is not provided for the current placement of the humidity probe during routine in-process humidity monitoring during packaging.
Firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
Firm did not initiate an investigation to determine the root cause of a humidity excursion during the packaging.
The company responded by saying that the investigation procedure was adequate and that personnel did not follow it.
This response was found to be inadequate because
it did not address the fact investigation documentation form lacks sufficient details of steps taken during the investigations and
failed to identify the root cause of the humidity excursion and provide the appropriate corrective and preventive actions.

yuansoul

这种文翻译的，毫无破绽

石头968

感谢分享，我不懂英文，不过我还是看英文比较好懂一些。
值得分享，值得学习！

vcjw

机器翻译能达到这个程度很不错了

sunwng

英文看不懂，看中文更糊涂

阳光海岸无悔

{:soso_e100:}

andyouandme

转载自丁香园

coriolan

sunwng 发表于 2013-6-17 20:25
英文看不懂，看中文更糊涂

看来不只是我有这感觉，说明不是我理解能力的问题

齐鲁制药

警告的是哪家？

youngzhou

谢谢分享

yongge

谢谢分享，不过翻译的有点别扭

yyqq868

原来以为外企一定要英语水平很高呢！还是谢谢分享！

piao0923

这份警告信中所提的3个缺陷与医药厂房设计没有任何关系，除了第一条稍微沾点边外，另外两条与厂房设计毫无关系。
第一条的大概意思是缺少足够的用于控制压差、微生物、温湿度等的设备（因为该公司的产品对湿度敏感），公司对车间的湿度控制措施不充分，或控制能力不足。
第二条的大概意思是没有规定各工序的生产时限，批记录上也没有规定包装时限（意思是产品生产必须在规定的时间内完成生产和包装，因为他们的产品对湿度是很敏感的）。规程中也没有描述关于湿度或时间超标时的保护措施。并且有关偏差调查不充分。
第三条的大概意思是对包装过程中的湿度超标情况没有启动偏差调查。
时间有限，不能逐条翻译。

呼呼_802

翻译的太好了

proxalis

谢谢分享