2019年人员培训相关的缺陷

• 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.

生产员工没有完成所有相关的学习,例如混合机的清洁,就签字确认具备生产溶液和悬浮液的能力。


2017年人员培训相关的缺陷


 

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

规程意识评估表没有按照培训规程的要求得到培训人的签字。

 

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

没有体系来确认所有需要培训的人员已经得到培训。

 

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

没有证据表明近期招聘的QA办公人员已得到GMP培训相关的评估

 

• 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.

生产操作员的培训记录未显示他们已得到隔离器操作的培训,但是他们已经在无菌生产中签了名。

 

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

没有控制确保只有得到培训的合同清洁人员才能进入厂房。

 

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

没有健全的流程来监测检验人员的培训和确认。

 

• 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.

但一个检验人员已获得色谱系统的资质,他被认为可以操作公司的另外两台系统,而没有进一步的关于系统间差异理解的能力检查。


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