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公司名称：AKUMS DRUGS & PHARMACEUTICALS LIMITED 受检地址： Plant IV, Sector - 6A, IIE, SIDCUL, HARIDWAR, UTTRAKHAND,249403, India 检查方：英国 检查日期：2016-4-13 产品：无菌人药 Nature of non-compliance : One critical and 3 major deficiencies were raised at thisinspection: The critical deficiency was for lack of sterility assurance asthere was insufficient evidence during validation to confirm that all ampoulesin the load met the sterilising conditions of 160oC for 2 hours, a weaksterility sampling plan and lack of qualification of the leak test cycle. Themajor deficiencies were for inadequate control and validation of sterilisation,deficiencies across all aspects of the quality management system and lack of arobust environmental monitoring programme. 13 other deficiencies covering allaspects of GMP were recorded but not formally reported so as not to distractfrom the critical and major deficiencies. 不符合情况： 检查中发现1个关键缺陷，3个主要缺陷。 关键缺陷是缺乏无菌保证，因为验证没有足够的证据证明来确认所有安瓿符合灭菌条件，即160度2小时，无菌取样计划薄弱，缺乏泄漏测试环节确认。 主要缺陷是灭菌控制和验证不够。缺陷涵盖质量管理体系所有方面，缺乏稳健的环境监测计划。 还有13个其它缺陷覆盖了GMP的所有方面，没有正式报告以免与关键和主要缺陷相混。
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