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

[debjacqui]

We have a company that compounds sterile products. We have a GMP facility and a non GMP state based compounding facility. They are operated separately with separate entrances although we are on the same site.
We are experiencing production limitations on the non GMP side of our operations and would like to be able to move some processes over to the GMP facility, if needed, but still retain their non-GMP status. Is this possible?
Could we use the GMP facility to produce preparations via non-GMP controlled processes? Are there any regulations or guidelines that specifically prevent this or allow this to occur? Thank you for your feedback.

 

[Ajit Basrur]

We have a company that compounds sterile products. We have a GMP facility and a non GMP state based compounding facility. They are operated separately with separate entrances although we are on the same site.
We are experiencing production limitations on the non GMP side of our operations and would like to be able to move some processes over to the GMP facility, if needed, but still retain their non-GMP status. Is this possible?
Could we use the GMP facility to produce prepartions via non-GMP controlled processes? Are there any regulations or guidelines that specifically prevent this or allow this to occur? Thank you for your feedback.

Welcome to the Cove

One clarification - you are using the term GMP and non GMP compounding facility. Do you mean Clean Room and non clean room ?

This is because GMP encompasses the entire chain of manufacturing right from raw material dispensing, compounding, filtration and filling of the sterile dosage formulations.

 

[Ronen E]

We have a company that compounds sterile products. We have a GMP facility and a non GMP state based compounding facility. They are operated separately with separate entrances although we are on the same site.
We are experiencing production limitations on the non GMP side of our operations and would like to be able to move some processes over to the GMP facility, if needed, but still retain their non-GMP status. Is this possible?
Could we use the GMP facility to produce prepartions via non-GMP controlled processes? Are there any regulations or guidelines that specifically prevent this or allow this to occur? Thank you for your feedback.

Hi,

If you intend to make some originally "non-GMP" products in a GMP facility and subject those non-GMP products to all requirements and processes enforced in the GMP facility, I see no problem with that (ignoring the costs aspect for a moment). But... if you intend to make those non-GMP products in your GMP facility, and exempt them from GMP controls that would not apply in the non-GMP facility - I think you're going down a risky route that will cause confusion, lack of proper control and quite likely deviations.

Ronen.

 

[PaulT]

I agree. Producting non GMP products in a designated GMP (FDA regulated) facility would take extra ordinary control measures to insure to the FDA that there is no possibility of product or component mix-up. In addition if you are using non GMP trained individuals in the GMP facility they would have to be trained not to have any involvement with the other GMP processes. The FDA is very adament about training of individuals in a GMP facility. The changes you are proposing will have numerous cost that your management might not be thinking of. Tread carefully!!!

 

[debjacqui]

Dear Ajit

Thank you for the welcome. To answer your question about what I mean when I say GMP and non-GMP, both processes will be performed in clean rooms, the only difference is the stringent requirements required by the GMP regulations regarding documentation, testing, facility, batch records etc. On the state based side (Non GMP), the pharmacist can release at his/her discretion whereas on the GMP side, QA reviews and releases batches.

 

[debjacqui]

Dear Ronen

Thank you so much for the feedback. The idea is to exempt the non GMP products from the processes and requirements enforced in the GMP facility. I do agree with your point that it could cause lack of control but what if we kept them totally separate i.e in another room completely and the two processes will never merge including no cross over of staff. Please note however, that the staff on the GMP side are also trained to perform the processes on the state based side. Would it then be possible do you think?

 

[debjacqui]

Dear Paul

Thank you for the response. The processes on the GMP side and the non GMP side are esssentially the same, except the controls and documentation and release criteria are very different. If the processes and staff were kept completely separate and line are done clearances done at the start of each batch, would the two processes be possible? Both sides (GMP and non GMP) utilise the same starting components, sterile consumables and equipment. A GMP technician can easily move between GMP and non-GMP processes if the need arose. Let me know your thoughts.

 

[MIREGMGR]

I'd think that a non-GMP compound--which as a matter of definition does not have a documented provenance, even if it began entirely with documented raw materials--that is present in a GMP facility would have to be regarded as a contaminant with regard to any GMP processing in that facility.

 

[PaulT]

Dear Paul

The processes on the GMP side and the non GMP side are esssentially the same, except the controls and documentation and release criteria are very different. If the processes and staff were kept completely separate and line are done clearances done at the start of each batch, would the two processes be possible? Both sides (GMP and non GMP) utilise the same starting components, sterile consumables and equipment. A GMP technician can easily move between GMP and non-GMP processes if the need arose. Let me know your thoughts.

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

 

[Ronen E]

Dear Ronen

Thank you so much for the feedback. The idea is to exempt the non GMP products from the processes and requirements enforced in the GMP facility. I do agree with your point that it could cause lack of control but what if we kept them totally separate i.e in another room completely and the two processes will never merge including no cross over of staff. Please note however, that the staff on the GMP side are also trained to perform the processes on the state based side. Would it then be possible do you think?

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:

A GMP technician can easily move between GMP and non-GMP processes if the need arose.

Vs.

...no cross over of staff.

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.