印度HOSPIRA无菌制剂和原料药EU GMP不符合

julia朱玉姣

受检地址：PLOT NOS: B3-B4, B5 (PART OF), B6 (PART OF), B11-B18, SIPCOT INDUSTRIAL PARK, IRUNGATTUKOTTAI, SRIPERUMBUDUR, IN-602 105, India
检查时间：2016-7-1
公司名称：HOSPIRA HEALTHCARE INDIA PRIVATE LIMITED
检查方：英国
不符合情况Nature of non-compliance                                                                :
                                                        The inspection identified a critical finding that was in regards to sterility assurance of product. The deficiency covered a number of areas including building classification and segregation by pressure differentials, aseptic processes that had not been optimised to reduce the risk of microbial contamination, aseptic process simulation investigations that failed to identify root cause and take appropriate actions, the environmental monitoring program was not based on a scientific justification and a number of areas of critical risk were not monitored, sterilisation activities including poorly designed autoclave load patterns that presented occluded surfaces and areas that were not free draining, SIP process that had pipework that was not appropriately sloped and also had manual interventions that were not appropriately detailed and all of the above issues were linked to a lack of scientific knowledge.
检查发现药品无菌保证关键缺陷。缺陷覆盖大量区域，包括建筑分级和压差区隔，无菌工艺没有进行优化以减少微生物污染风险，无菌工艺模拟调查未能找出根本原因并采取适当措施，环境监测计划不是基于科学论证，大量关键风险区域未进行监测，灭菌活动包括灭菌器装载模式设计不良，咬合面和区域不能自由排水，SIP工艺管道坡道不恰当，人工干预未进行恰当的详细说明，所有上述问题均与缺乏科学知识有关。

zysx01234

那就枪毙呗，哈哈

麦田.守望

与缺乏科学知识有关？太简单了，多招几个博士、教授过来。钱不是问题！

kkkkkking

这都是老问题了

阿炳1987

是不是科技应该再发达点，不需要使用人工（一个都不要），全自动化设备生产，最好是不需要投入原辅料就能搞出合格产品来，空手套白狼呗…

julia朱玉姣

刚刚看到某外媒报道，说这次检查是四家联合检查，美国FDA.英国mhra.加拿大药监.澳大利亚TGA.…而且标题是辉瑞印度site被联合检查后禁掉

ykdx99406

看看英文原版。