无菌玻璃瓶裂痕的风险及评估

繁华洛尽

无菌玻璃瓶裂痕的风险及评估
来源：OurGMP


　　FDA在给印度某公司的警告信中描述了无菌注射剂玻璃瓶裂痕的风险。


　　FDA在警告信中提到：


　　defects haven't always been detected - particularly when cracks occur in the glass bottle under the cap


　　当玻璃瓶在铝盖下面的部分产生裂缝时，裂痕是难以发现的。


　　The company's reply mentions the use of a new test machine assuring 100% controlling which isn't sufficient for the FDA as defects occurring after the filling process cannot be detected


　　该公司的回复使用新的检测机器来确保100%控制，但这对于FDA来说是不够的，因为灌装工艺之后发生的裂痕是无法检出的。


　　由此FDA要求：


　　A risk assessment of all lots of the sterile solution in the U.S. market


　　对所有在美国市场上的无菌溶液批次进行风险评估


　　A revision of the CAPA concept regarding the leaking defect


　　修订关于泄漏缺陷的CAPA概念


　　An assessment of all other products to determine whether those can also be affected by the leaking defect .


　　对所有其它产品进行评估，确定是否可能会受到泄漏缺陷的影响


　　Shipping studies with regard to the leaking defect


　　对泄漏缺陷进行运输研究


　　A review of the suitability of the packaging components used for the process including an overview of the qualification status of the packaging suppliers


　　回顾工艺所用包材部件的适当性，包括对包材供应商的确认状态的综合评估


　　Process capability studies with regard to capping


　　对于封盖工艺进行工艺能力研究


　　Optimised procedures for complaints processing


　　优化客户投诉处理程序


　　Improvement of CAPAs handling


　　改进CAPA处理程序

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