本帖最后由 beiwei5du 于 2018-1-6 23:11 编辑
这个可能会有用，因为毕竟是483表，其为现场检查结束后的检查官负责人（investigator）起草的，并且是出自其个人的判断，毕竟没有法律法规效应，所以其策略也是规避相应的法规条文，但是其起草483表至少需要依据，所以间接性的通过将法规条文（比如 21 CFR 211.22(d)）转化为长描述（long description，比如The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. Specifically, ***）,从而间接的指引出来。由于长描述毕竟仅仅是个框架语句，其最后统计的话就通过Cite Id进行反向统计出来即是。所以实际我们在看条款的时候，可以凭借能搜索文档全文的软件搜索“The responsibilities and procedures applicable to the quality control unit ”即可，找出涉及该21 CFR 211.22(d)的条483表内容。
https://www.fda.gov/ICECI/Inspections/ucm250729.htm#A_Short_Description_of_Citations
Observations are listed on a Form 483 in order of significance by the investigator. The format of any single observation begins with a statement based in a citation of law, regulation or Act and is followed by a statement of specific conditions observed during the inspection. For a description of the citations and the data in the attached spreadsheets, please see [color=rgb(0, 0, 0) !important]A Short Description of Citations. These fiscal year reports list the standardized citations, in decreasing frequency of use for TurboEIR system issued 483s, the first component of the 483 observations, the short and long plain language citations describing the laws, regulations or Acts and the CFR or other reference. There may be many citations for each CFR reference, addressing specific and distinct elements of the referenced law or Act. As laws and regulations are frequently complex, identifying multiple areas for concern, the short description identifies the specific element which is objectionable for an observation. The long description and reference number provide context for a short description that is cited in an observation. For examples of inspectional observations and how the standardized citations are used to record observations, please see the ORA Reading Room for examples of recently issued 483s. A Short Description of CitationsCitations are maintained in a database and are reviewed, edited and updated on a periodic basis. Citations relate to a Code of Federal Regulations (CFR) reference, and there may be many citations for a single CFR reference. To create an FDA Form 483, citations are selected from the pre-established system or database. The Long Description is entered into the FDA Form 483, ensuring uniformity of presentation, then specific information related to the observation may be entered, and the citations may be ranked by significance on the 483. At the present time, the citation database does not contain cites for all areas of the Food Drug and Cosmetic Act or the regulations enforced by FDA, so FDA Form 483’s that reference these are written manually and the citations are not be available for reporting from this database. In the fiscal year reports, a citation has the following display:
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发表于 2018-1-6 11:54:12
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