We run one here and trust me when I tell you the best thing to do is to actually go to one and see for yourself what the deal is. There is a lot to it. I suggest you take some classes as well in GxP. Imagine this, an FDA inspector comes in to the lab and picks out one HE slide. That slide has several SOP's attached to it and those SOP need to be in NAACLS format, the folks who did all the work on the HE from necropsy through labeling need to have a cv on file showing relevant training and experience that states they are trained to do whatever their part of the HE they did, and that they read the SOP used on the process. Which hurts people like Joe Nocito who still can't read(hi Joe). If they cut the section there needs to be proof they are trained to section. Then oh yeah all of the reagents used to perform necropsy, trimming, embedding, microtomy, staining, coverlsipping, labeling, archiving(another GLP situation) need to be dated and labeled with lot numbers, batch numbers. There needs to be logsheets on everything from temps of the water bath temps and water checks, when the slides were stained, when the tissue was run on the processor and all of the maintenance as well as proper use of maintenance SOP's. Did you use a scale or pipette? Where are the calibration logs? When you calibrated the Ph meter did you use outdated ph buffers, I hope not loser cuz you just failed that part of the inspection. Take any CAP inspection and multiply it 5 fold on the level of detail on everything. Running a GLP lab is doable and a great way to run a lab, but you will need to increase your staff in the lab just to cover the documentation. Good Luck. This is as far as we can go here due to the nature of our business.
Nick Madary, HT/HTL(ASCP)QIHC Medimmune Histology Mgr, OMW, Area 4, Lab 2438 301.398.4745(vm) 301.398.6360(lab) 301.398.9745(fax) To the extent this electronic communication or any of its attachments contain information that is not in the public domain, such information is considered by MedImmune to be confidential and proprietary. This communication is expected to be read and/or used only by the individual(s) for whom it is intended. If you have received this electronic communication in error, please reply to the sender advising of the error in transmission and delete the original message and any accompanying documents from your system immediately, without copying, reviewing or otherwise using them for any purpose. Thank you for your cooperation. _______________________________________________ Histonet mailing list Histonet@lists.utsouthwestern.edu http://lists.utsouthwestern.edu/mailman/listinfo/histonet