The production operative was signed off as trained in raw material assessment based on read and understand questionnaire with no practical assessment.

提供員工依靠自讀和理解調(diào)查問(wèn)卷來(lái)簽字確認(rèn)通過(guò)原料評(píng)估的培訓(xùn)，而沒(méi)有實(shí)際的評(píng)估。

?

? The production operative was signed off as competent for manufacture of solutions and suspensions had not completed training in all associated duties such as cleaning of compounding equipment.

提供員工沒(méi)有完成所有相關(guān)的學(xué)習(xí)，例如混合機(jī)的清潔，就簽字確認(rèn)具備提供溶液和懸浮液的能力。

?

? Procedure awareness assessment forms were not all signed off by the trainer as required by the training procedure.

規(guī)程意識(shí)評(píng)估表沒(méi)有按照培訓(xùn)規(guī)程的要求得到培訓(xùn)人的簽字。

?

? There was no system for confirming that all personnel that required training had been trained.

沒(méi)有體系來(lái)確認(rèn)所有需要培訓(xùn)的人員已經(jīng)得到培訓(xùn)。

?

No evidence was seen for competency assessment for the GMP training of a recently recruited QA Officer.

沒(méi)有證據(jù)表明近期招聘的QA辦公人員已得到GMP培訓(xùn)相關(guān)的評(píng)估

?

? The training record of production operator did not show they were trained in the operation of the isolator despite being signed off for aseptic manufacturing.

提供操作員的培訓(xùn)記錄未顯示他們已得到隔離器操作的培訓(xùn)，但是他們已經(jīng)在無(wú)菌提供中簽了名。

?

? There was no control to ensure that only trained contract cleaners enter the manufacturing facilities.

沒(méi)有控制確保只有得到培訓(xùn)的合同清潔人員才能進(jìn)入廠(chǎng)房。

?

? There was no robust process for the monitoring of analyst training and qualification.

沒(méi)有健全的流程來(lái)監(jiān)測(cè)檢驗(yàn)人員的培訓(xùn)和確認(rèn)。

?

? When an analyst was qualified on one chromatography system, he was considered qualified on the other two systems used on site without any further competency checks performed related to understanding of differences between the systems.

但一個(gè)檢驗(yàn)人員已獲得色譜系統(tǒng)的資質(zhì)，他被認(rèn)為可以操作公司的另外兩臺(tái)系統(tǒng)，而沒(méi)有進(jìn)一步的關(guān)于系統(tǒng)間差異理解的能力檢查。