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

無(wú)菌操作人員資質(zhì)認(rèn)證程序有缺陷，具體來(lái)說(shuō)，

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環(huán)境監(jiān)測(cè)趨勢(shì)報(bào)告中人員監(jiān)測(cè)的偏移率有所增加，這種負(fù)面趨勢(shì)歸因于無(wú)菌技術(shù)和培訓(xùn)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.

用于執(zhí)行無(wú)菌操作XX的SOP不足以確保充分的無(wú)菌技術(shù)，因?yàn)樵诿枋鯴X的物料流動(dòng)時(shí)缺乏細(xì)節(jié)，包括消毒和物料轉(zhuǎn)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.

對(duì)在潔凈室工作的操作人員缺乏監(jiān)督。例如，在觀察生產(chǎn)過(guò)程中，主管被發(fā)現(xiàn)未對(duì)沒(méi)有遵循正確無(wú)菌技術(shù)的操作人員提供糾正指導(dǎo)。

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.

在進(jìn)行無(wú)菌操作之前，沒(méi)有確認(rèn)操作人員是否符合最新的培訓(xùn)要求。盡管主管收到操作人員培訓(xùn)期滿的通知，但沒(méi)有保證和/或文件證明操作人員在進(jìn)行無(wú)菌操作之前已經(jīng)過(guò)充分培訓(xùn)，可以在潔凈室工作。

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.

操作人員沒(méi)有遵守常規(guī)無(wú)菌技術(shù)的SOP，此外，在觀察無(wú)菌操作時(shí)，有批記錄說(shuō)明（操作步驟，但未被遵守）。例如，在觀察XX程序期間，XX操作員沒(méi)有按照批記錄步驟XX中明確規(guī)定的那樣使用XX。

根據(jù)《中國(guó)經(jīng)營(yíng)報(bào)》在2024年10月12日發(fā)布的消息，其中援引了英國(guó)《金融時(shí)報(bào)》的消息稱，藥明康德擬將旗下負(fù)責(zé)細(xì)胞和基因療法（CGT）生產(chǎn)的藥明生基位于美國(guó)費(fèi)城的基地掛牌出售，這些討論已經(jīng)進(jìn)行了數(shù)月，藥明康德已經(jīng)與一些潛在的買(mǎi)家進(jìn)行了接觸，以探討收購(gòu)其全部或部分資產(chǎn)的可能性。10月8日，藥明康德發(fā)布《關(guān)于WuXi ATU媒體報(bào)道的自愿性公告》，回應(yīng)了此前市場(chǎng)對(duì)于其“拋售部分海外資產(chǎn)”相關(guān)消息的猜疑，公告稱，公司目前正在評(píng)估各種選項(xiàng)以保持WuXi ATU業(yè)務(wù)的持續(xù)運(yùn)營(yíng)，最終是否選擇出售WuXi ATU業(yè)務(wù)存在不確定性。

此外，在2023年3月底，公開(kāi)消息顯示，藥明生基關(guān)閉了上海臨港基地的生產(chǎn)功能。