Non GMP processes in a GMP facility - Can it be done?

[Lingabathula]

Hi ,
Yes you can do non GMP process in GMP permitted company as long as you process both in two different rooms to avoid cross contamination and keep both process documentation separately. I have worked with the above conditions in one of my job. We kept GMP area separate and non GMP area separate under the same roof. As long as you are not interrupting the GMP process for the product or rules for the GMP process it is allowed.

 

[Lingabathula]

if you want to use GMP strile room and equpent you have to follow GMP rules , by following GMP rules you can manufacture non gmp products, as you need to use those again for the GMP process for the next product, so you have to maintain the same status as GMP. if you don't want to use the same equipment room again and if it is not interrupting other GMP process then it is fine.

 

[debjacqui]

The process are the same execpt the controls, documentation and release criteria,,,EXACTLY. That is what the FDA would be looking at in any inspection. How do you keep the two separate (materials, documentation WIP, people and product) The closer the processes are to one another the harder it is to maintain separation in the eyes of an inspector. Can it be done? Possible Would I try to do it? Probably Not

Thank you again for the response. I have relayed all the comments I have received in this forum to management for review. I appreciate the responses received.

 

[debjacqui]

If you "keep them totally separate i.e in another room completely and the two processes will never merge including no cross over of staff" then the risk may be reduced but it will still be significant in my opinion.

Just as an example:



Vs.



Many times organisations tend to go by cost / operational considerations once the quality set-up has been determined, rather than prioritizing quality over cost / operations on a strict basis; so, I guess that in time the need will arise and rules will be bent. It doesn't mean anything about your company, it's human nature. Human nature also holds that when a "GMP technician" returns to a "GMP facility" after spending some time at a "non-GMP facility", some erosion in attitudes will occur.

Cheers,
Ronen.

I agree about the possible erosion statement.

 

[debjacqui]

if you want to use GMP strile room and equpent you have to follow GMP rules , by following GMP rules you can manufacture non gmp products, as you need to use those again for the GMP process for the next product, so you have to maintain the same status as GMP. if you don't want to use the same equipment room again and if it is not interrupting other GMP process then it is fine.

If this were to occur, the processes will be in different rooms with no possible meeting of staff or components between GMP and non GMP products.

 

[Lingabathula]

Yes thats right.