1. The aseptic operator qualification program is deficient, specifically,

 

无菌操作人员资质认证程序有缺陷，具体来说，

 

i. There was an increase of excursion rates in personnel monitoring in the (b)(4) environmental monitoring trend report. This negative trend was attributed to inadequate aseptic technique and training.

XX环境监测趋势报告中人员监测的偏移率有所增加，这种负面趋势归因于无菌技术和培训的不足。

ii. The standard operating procedures (SOPs) used to perform aseptic operations (b)(4) are not adequate to ensu1e sufficient aseptic technique as noted by the lack of detail in describing the flow of materials (b)(4) including disinfection an material transfer practices.

用于执行无菌操作XX的SOP不足以确保充分的无菌技术，因为在描述XX的物料流动时缺乏细节，包括消毒和物料转移操作。

iii. There is lack of supervisory oversight of operators working within the cleanroom. For example, during observation of production, a supervisor was seen to not provide corrective instruction to an operator who was not following proper aseptic techniques.

对在洁净室工作的操作人员缺乏监督。例如，在观察生产过程中，主管被发现未对没有遵循正确无菌技术的操作人员提供纠正指导。

iv.There is no verification that operators are up to date with training requirements before performing aseptic operations. Although the supervisor receives notification of expiration of an operators' training, there is no assurance and/or documentation that the operators are sufficiently trained to work in the cleanroom prior to performing aseptic operations.

在进行无菌操作之前，没有确认操作人员是否符合最新的培训要求。尽管主管收到操作人员培训期满的通知，但没有保证和/或文件证明操作人员在进行无菌操作之前已经过充分培训，可以在洁净室工作。

v. Operators are not following SOPs for general aseptic technique, in addition to, batch record instructions as evidenced during observation of aseptic operations. For example, during observation of (b)(4) procedure, (b)(4) operator did not use (b)(4) as explicitly stated in steps (b)(4) of the batch record.

操作人员没有遵守常规无菌技术的SOP，此外，在观察无菌操作时，有批记录说明（操作步骤，但未被遵守）。例如，在观察XX程序期间，XX操作员没有按照批记录步骤XX中明确规定的那样使用XX。

根据《中国经营报》在2024年10月12日发布的消息，其中援引了英国《金融时报》的消息称，药明康德拟将旗下负责细胞和基因疗法（CGT）生产的药明生基位于美国费城的基地挂牌出售，这些讨论已经进行了数月，药明康德已经与一些潜在的买家进行了接触，以探讨收购其全部或部分资产的可能性。10月8日，药明康德发布《关于WuXi ATU媒体报道的自愿性公告》，回应了此前市场对于其“抛售部分海外资产”相关消息的猜疑，公告称，公司目前正在评估各种选项以保持WuXi ATU业务的持续运营，最终是否选择出售WuXi ATU业务存在不确定性。

 

此外，在2023年3月底，公开消息显示，药明生基关闭了上海临港基地的生产功能。

 

 

来源：GMP干货

关键词： 无菌操作