FDA警告信：Wockhardt,Ltd.
GMP办公室翻译组
翻译：流浪的沙子
校对：Owen
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昨夜，FDA挂出对Wockhardt,Ltd.的警告信，缺陷涉及：撕毁记录、非正式记录、检验结果不报告、无菌服破损、计算机化系统未验证、气流流型失败等。具体缺陷如下：
1.Yourfirmfailedtoestablishandfollowappropriatewrittenproceduresthataredesignedtopreventmicrobiologicalcontaminationofdrugproductspurportingtobesterile,andthatincludevalidationofallasepticandsterilizationprocesses(21CFR.(b)).
未能建立和遵循适当的书面规程防止无菌药品的微生物污染，包括所有无菌和灭菌工艺的验证。
Duringtheairflowanalysis(smokestudy)ofasepticconnectionsonyour(b)(4)equipmentinsidethelaminarairflow(LAF)ISO-5area,ourinvestigatoridentifiedairflowdisturbancesandturbulence.Underdynamicconditions,airdidnotsufficientlysweepacrossandawayfromsterileconnections,sothesterilityofanyproductprocessedundertheseconditionscouldbe