2011年宁波一家API厂 警告信中英文对照.pdfVIP

Ningbo Smart Pharmaceutical 警告信 中英文对照 （完整的警告信内容请参见以下链接：） /ICECI/EnforcementActions/WarningLetters/ucm249425.htm. ************************************************************************************************************************* Warning Letter Dear Mr. Wu: We have reviewed your firm’s response of November 19, 2010, and note that it lacks sufficient corrective actions. 我们审核了你们公司在2010 年 11 月19 日的回复，发现纠正措施不够充分。 Specific deviations observed during the inspection include, but are not limited, to the following: 以下是检查过程中发现的具体缺陷，但是不局限于，以下内容： 1. Failure of your quality unit to ensure that materials are appropriately tested and the results are reported. 你们的质量部门没有能够确保对物料进行适当的测试并报告测试结果。 For example, your Quality Control Unit (QCU) approved the release of four XXX batches (#XXX) without data to support that the test for organic volatile impurities (OVI) met release specifications. 例如：你们的质量部门 （QCU ）在没有对残留溶剂 （OVI）进行检测证明其符合标准的情况下，批准放行了 四个批次(#XXX)的产品。 While your Certificates of Analysis state that OVI levels conformed to specifications, the inspection found that no testing was done. 然而在你们在COA 上声明残留溶剂符合标准，检查员发现实际没有进行过检测。 It is essential that your firm only report results to customers when you have actually performed the analysis. 只有在实际进行了检测之后才能报告检测结果给客户，这一点是非常重要的。 This serious CGMP deviation raises concerns regarding the reliability and integrity of other data generated by your firm. While we acknowledge the commitment in your November 19, 2010 response to improve the QCU, we remain concerned that your investigation is not comprehensive enough to determine the extent and impact of the problem. A review of the XXX OVI records of batches that were not previously tested is not sufficient. In your response, provide a complete corrective action plan that includes a retrospective review of