Regulatory affairs: workspace

[bartjoosen]

Hello,

currently we are planning some reorganisations in our lab, and there is a discussion about the GLP rules about a workspace setup.

The setup we would like is an long table, on one side an HPLC, connected with the computer, this computer is also used for the writing of reports, so there is some space for paperwork, and on the same table a place for making up the dilutions, ......
Our QA department says it isn't GLP because of the sensitive instruments and the use of the solvents for the dilutions (which is mostly in mobile phase).

Are there labs running with the setup described above, which are GLP conform? Or is our QA department right?


Thanks for your time


Bart

[Dan]

Bart,

I do not see a GLP (or GMP) non-compliance issue with the workspace design that you describe.

Perhaps your QA group is concerned if there is an accident where some solvent is spilled on the analyst's paperwork. If the paperwork is destroyed and cannot be replaced, then it is a loss of GLP documents. Experiments would then need to be repeated. Of course, this is an issue with all labs, not just the specific design that you describe. I have seen some lab notebooks that have had solvent spilled on them, but usually the raw data that was recorded was recoverable.

That said, I would not want to use the workspace that you describe from a practical point of view. My reasons:
1) It may not be easy to share the computer for both the HPLC and the report writing.
2) Many people are not comfortable working on the computer for report writing while wearing their lab safety equipment. I have known many people that cannot wear safety glasses/goggles while working on the computer because of eye strain. This is a safety issue.

Therefore, I would invest in a second computer and have two separate workstations: one for the lab work and one for the report/documentation work.

Regards,
Dan

[Bruce Hamilton]

The obvious answeris to ask your people to explain their reasons more clearly.

I wonder if it's a GLP issue because of chemical safety issues, rather than electronic data issues. We have a dedicated write up area/desk very close ( ususally adjacent ) to benches - so people can put reference texts/methods there and write reports, rather than on a surface that may have had glove contact, or chemical containers ( opened or closed), stored on it.

I'm with Dan on this - I think his recommendations are spot on. In my experience, it's never a good idea to use an instrument-controlling computer for other tasks, regardless of the convenience.

Not only are there user access, chemical safety ( unless all are wearing gloves ), and potential software conflict issues ( On Win NT some versions of Chemstation could crash randomly if Microsoft Office programmes were also installed and used ), but whenever some software or hardware on the computer is updated, the qualifciation circus comes to town again.

Please keep having fun,

Bruce Hamilton

[Jumpshooter]

The laboratory area that I work in is obviously in severe violation of all the codes---we have 2 LC's, an LC-MS, 3 GCMSD's, 5 computers each with a laser printer, solvent bottles precariously balanced on top of the flourscent detector and between the printers, an untold number of computer cables snaking between the LC's, under the lab bench, and finally retro-fitted tygon tubing protruding from at least 5 cieling panels and connect to the compressed air and nitrogen lines.