[Histonet] GLP lot# documentation

[Eileen Akemi Allison]

Hello Histo Land:

I am the new IHC manager for a research lab which works primarily with animal tissue and we are moving towards GLP compliance for our department. We have an extremely large client base which consists of Big Pharma, private research companies, universities, etc…  We are in the process of updating our SOW and SOP forms, Stain line maintenance forms, solution stainer change logs, etc…  

I have a question regarding documenting lot #’s for our hematoxylin counterstain protocol for IHC's.  Do any of you who are GLP compliant document lot numbers for your alcohols and xylenes?  Our director and QA officer would like to incorporate documenting lot numbers for alcohols and xylenes.  Our histology department who is GLP certified only documents their lot numbers for Hematoxylin, Eosin, Bluing solution and High Def solutions for their H&E stain line.  They currently do not document lot numbers for  alcohols and xylenes.   I have primarily worked for Clinical pathology labs, who did not document lot numbers for alcohols or xylenes.  Please let me know if you do.

Thanks,
Akemi
 
Eileen (Akemi) Allison, BS, HT/HTL (ASCP)
Manager – IHC Department
HistoTox Labs, Inc.
2108 55th St. Suite 120
Boulder, CO 80301
Cell: 408-335-9994
www.histotoxlabs.com <https://histotoxlabs.com/>