2019年人員培訓相關的缺陷

? 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.

生產員工沒有完成所有相關的學習,例如混合機的清潔,就簽字確認具備生產溶液和懸浮液的能力。


2017年人員培訓相關的缺陷


?

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

規程意識評估表沒有按照培訓規程的要求得到培訓人的簽字。

?

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

沒有體系來確認所有需要培訓的人員已經得到培訓。

?

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

沒有證據表明近期招聘的QA辦公人員已得到GMP培訓相關的評估

?

? 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.

生產操作員的培訓記錄未顯示他們已得到隔離器操作的培訓,但是他們已經在無菌生產中簽了名。

?

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

沒有控制確保只有得到培訓的合同清潔人員才能進入廠房。

?

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

沒有健全的流程來監測檢驗人員的培訓和確認。

?

? 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.

但一個檢驗人員已獲得色譜系統的資質,他被認為可以操作公司的另外兩臺系統,而沒有進一步的關于系統間差異理解的能力檢查。


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