We have a small lab which runs both non-GLP and GLP compliant studies and I'd like to get some feedback on how others run their facilities with this setup. Do you manage all studies in the same process/documentation as if for a GLP study or do you have a differentiation such as a tier system in place? Any feedback and insight on how best to manage would be appreciated
Cate 23/10/2020 16:32
In my experience facilities have one approach to the conduct of studies regardless if the work is making a formal claim of compliance with GLP or not. The only difference is the involvement of QA. A non-GLP study would not be audited..
RQA GLP Committee 20/11/2020 08:40
Thank you Cate for your response, we agree with you. You should not have two systems in place and should go with the 'higher' practice. It is difficult running two systems alongside each other.