I work in an corporate analytical lab where manufacturing work is not required to done according to GLP guidelines but some R&D work is. Does anyone know how regulatory agencies feel about a lab where some of the people perform GLP work and report through a "GLP-oriented structure" but others in the same lab report to a non-GLP regulated structure? In other words, in the same lab there would be some people performing GLP work for R&D and reporting to R&D, while others in the same lab would perform non-GLP work and report to manufacturing. Much of the equipment could not be separated so both GLP and non-GLP people would be using the same equipment.

I work in corporate R&D where some of our products are OTC pharmaceuticals and work for them is done by strict cGMP with 21CFR11, whereas for the non-pharmaceutical stuff isn't. Some of our instrumentation is dedicated to pharmaceuticals and is 21CFR11, some isn't.

In my workplace, we have both GLP and non-GLP analytical work going on with overlapping instruments. In our audits, the auditors always want to see documentation in the instrument logbooks as to which type of analysis is being performed (GLP or non-GLP).

You may want to consider a document (SOP) which will define which instruments, procedures, etc are being used for GLP, and how the Study Director adn the QAU will ensure that only these are followed. Actually, for the lab operation, it seems to me that much of what is required for GLP would fit in welll with what is required for GMP. The GLP, for example require that you document when a instrument is found to need non-routine maintenance, how it was discovered, when it was discovered, who discovered it, etc. Implementing this type of control would probably do nothing but improve your control of the instruments in the non-GLP environment Try it- you may like it (remember Sam-I-Am and the green eggs and Ham)

From original anonymous:

Manufacturing is not required to be GMP and thus, is not. Nor, I would guess, do they have any interest in setting themselves up to be GMP compliant. The problem that I am seeing is that there would be personnel operating under GLP and different people using some of the same equipment in the same lab that are not required to operate under GLP. Some equipment might be able to be set up under password protection to preclude its use by non-GLP personnel, but some equipment could not and would be operated by both "groups". We would essentially have two labs operating from the same physical location using much of the same equipment. One lab would be operating under GLP, the other lab would be under a different reporting structure with no requirement or perceived need to operate under GLP.

The issue is probably not as hard a question as you may think. In terms of GLP, this is a protocol driven quality system. For the instrumentation, one needs some sort of documentation as to what is being run under GLP, and who is running it. The people who are doing the GLP need to be appropriately trained in the methods, etc, as well as in GLP. This must be documented. Also, there must be a system for routine maintenance and non-routine maintenance for the instruments. It is not a heinous thing to implement in a lab in any case, whether GMP, GLP, or any other quality system. Why would you not want to know when the instruments have needed service,or when they have needed "emergency" service and why. A good GLP auditor would definitely come in and want to know how you could differentiate in terms of the instrument care, training, maintenance, etc. You may want to get a copy of 21 CFR Part 58. If you want to ask questions about GLP in a lab, off-line or on line. please feel free to contact me.

Second thoughts.

I have worked in non-GMP, non-GLP, GMP and GLP labs over the years. I will say without a doubt, that in terms of what GLP requires in the actual operation of the lab is relatively easy to implement and in no way inhibits the activity of the lab. It is, after all, a quality system. In regard to the lab, a little bit of effort will serve to answer most auditor questions. The hard questions would be in terms of the study director and QAU roles, archives, etc.

Good luck.