FDA认证483条款缺陷项中英对照.doc

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FDA Warning Letters, Form 483 Observations and Establishment Inspection Reports – Preview
FDA警告文字,来自483观测资料和预先检查报告。
Important: Warning letters and other FDA inspection documentation should be interpreted in the context of full content. Just looking at extracts may be misleading. And sometimes they include good advice from the FDA not mentioned in the extracts.
重要性:警告文字和其他的FDA检查文件必须说明,根据上下文包括全部内容。仅是看摘录可能被误解。并且有时要包括从FDA那里征求好的建议,而不是只提到摘录。
FDA 483 Inspectional Observations, EIRs & Warning Letters - Preview keywords and excerpts
Type
Content&deviations
File
 
Keywords, selected examples (plete).
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FDA检查报告,EIRS和警告文字-预览关键词和摘录。
类型内容和目录
关键词,选择事例(不用完整)
尽力画出“D”来观察、印刷和/或下载所有文件的全部内容。
(在这部分预览方式中,CLICK将使你形成定货表格。)
483
85 items
W-156
Keywords: Water systems, diagrams, process validation, cleaning validation, batch record review, training, instrument calibration, reserve samples, testing, product specification, distribution records, analytical method, USP standard, failure investigation, labeling, SOPs
483 关键词:水系统,图表,过程确认,清洁确认,一批记录:有回顾,培训,仪表校正,储备样本,检测,制品技术规格,分析方法,USP标准,故障调查,标签,SOPS。
Primary deviations: missing diagrams, no installation qualification, no operation qualification, no batch record review, inadequate GMP training, inadequate equipment calibration, inadequate storage of reserve samples, SOPs not approved, inadequate procedures for sampling and testing
Examples: 
-There was no diagram of the water system
- Batch records not reviewed by QC,
- Routine calibration not performed according to a written program
- Conductivity meters not calibrated to an NIST traceable device
- Batch records lack a description of name of the equipment
- No reference in analytical method to recognized standard method. 
- Current SOPs not reviewed and approved by QCU
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W—156 主要错误: