EU GMP

[AQARA]

HI EVERYONE,

Would appreciate your input.

Are lab coats required for QA team members who occasionally enter the lab for quick checks? Is there a standard or guidance specifying PPE requirements for different roles within EU RUO manufacturer company that has ISO 13485 CERT?

THANKS.

 

[Ed Panek]

Why do your lab members wear lab coats? That will help us.

 

[AQARA]

Why do your lab members wear lab coats? That will help us.

because they are develop/manufacture products that use human urine/whole blood or plasma as samples/control panel.

 

[Ed Panek]

If it's a controlled environment I think it needs to be all the time unless I'm missing a detail.

 

[AQARA]

If it's a controlled environment I think it needs to be all the time unless I'm missing a detail.

no, it is not a controlled environment.
i can not see the point why QA needs to wear lab coat when they enter the lab for quick check since they don't perform any task with direct contact with hazardous materials!

 

[Ed Panek]

If there is no risk with QA entering this room to do work then document that rationale. Our production requires hair nets and masks for direct production employees. QA can visit for batch records without hair nets and masks.

For you, this sounds like writing "Personnel that handle biohazard (Or whatever your work in process is called) are required to wear the required PPE" If your engineering design team hasn't required it I think you can justify what you are asking for.

 

[SeanN]

Manufacturing products that use human urine/whole blood or plasma is very likely a controlled environment (there are different levels of control/requirements). The point is not only about safety for QA staff if they "don't perform any task with direct contact with hazardous materials" but more about (cross-) contaminations to the products from their clothes (different types of microorganisms could be found). Further, QA staff move from room to room. They are in daily contact with people from both controlled and non-controlled env. I am a QA person and I use lab coast & wash every week.

 

[AQARA]

Manufacturing products that use human urine/whole blood or plasma is very likely a controlled environment (there are different levels of control/requirements). The point is not only about safety for QA staff if they "don't perform any task with direct contact with hazardous materials" but more about (cross-) contaminations to the products from their clothes (different types of microorganisms could be found). Further, QA staff move from room to room. They are in daily contact with people from both controlled and non-controlled env. I am a QA person and I use lab coast & wash every week.

we are manufacturing RUO products. our products are not regulated under any current jurisdiction. do QA still need to wear lab coat?

 

[planB]

Occupational safety regulations are independent of how your product is (not) regulated or of how you define your personnel roles in your company. As @Ed Panek pointed out: document your rationales in line with (typically national) occupational safety regulations, preferably signed by the person responsible for occupational safety in your organisation, and move on from there.

 

[SeanN]

we are manufacturing RUO products. our products are not regulated under any current jurisdiction. do QA still need to wear lab coat?

Probably no since RUO products are often not subject to the same level of regulatory oversight as products intended for clinical or diagnostic use. So it totally depends on you, as planB and Ed Panek said above.