20150805 ECA新闻：在全球网站上可获得FDA的483和回复

20150805 ECA新闻：在全球网站上可获得FDA的483和回复  
2015-08-06 16:44:33|  分类： ECA新闻
   
GMP News
05/08/2015
FDA 483s and Responses available in the World Wide Web
FDA的483和回复在全球网站上可获得
The Freedom of Information Act (FOIA) allows anyone to request copies of records that are normally not fully prepared for public distribution. According to the Act, materials and other information have to be available in publicly accessible "electronic reading rooms" with systems that also allow users to electronically search for files and index materials.
信息自由法案（FOIA）使得所有人都可以申请常规并不会向公众公开的报告副本。根据该法案，材料和其它信息也必须让公众可以从“电子阅览室”里查看，其系统也允许用户进行指定文本和索引材料的电子搜索。
However, not everybody interested in certain documents has the time and possibility to visit these public reading rooms. But the Office of Regulatory Affairs (ORA) Electronic Reading Room also displays copies of certain records in the World Wide Web. ORA is making these records publicly available either proactively at ORA's discretion or because they are "frequently requested" per the Electronic Freedom of Information Act Amendments from 1996.
当然，并不是所有对特定的文件感兴趣的人都有时间和机会云访问这些公众阅览室。但是法规事务办公室(ORA)电子阅览室也在全球性网站上展示某些记录的副本。ORA将这些记录公开有时是因为他们自己的判断，有时是因为这些记录被根据1996年修订的电子信息自由法案“频繁地申请”。
Under the URL of the ORA FOIA Electronic Reading Room, everyone can review 483s*, 483 responses, Consent Decree Correspondence** and other interesting documents. These may also provide information on what the FDA expects - helping companies to prepare for an inspection by the agency.
在ROA FIOA电子阅览室的链接下，所有都可以浏览483表和回复、同意判决书通信记录和其它有意思的文件。这些也可以提供关于FDA期望的信息---有助于公司准备由官方进行的检查。
*483 is the number of a form used by an FDA Investigator to document the deficiencies he found during an inspection. It is issued at the end of the inspection and should be answered officially. This response is expected within 15 working days after its issuance. Only then it is guaranteed that the statement will be taken into account in a possible Warning Letter.
483是FDA调查员用于记录检查中发现的缺陷的表格编号。一般是在检查结束时签发，要受检公司正式回复。该回复要求在其签发后15个工作日内提交。只有那时才会考虑是否需要签发警告信。
**If a company has repeatedly violated cGMP requirements, FDA may make a legal agreement to force the company to take specific actions. A Consent Decree can include penalties and due dates for the actions defined. Sometimes a consulting company will check the company and streamline systems and processes. A final inspection is carried out at the end. In the meantime, profits can be skimmed off.
如果一个公司一再违反CGMP要求，FDA可能会签署一份法律协议强制该公司采取特定的措施。一份同意判决书可以包括罚金和指定措施的执行期限。有时，一个顾问公司要检查该公司，提高其系统和程序。最后，会进行一个最终检查。同时，利润也就丢掉了。
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