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Hi all,
I would have a question regarding the in vivo potency testing performed for the batch release.
The experiment consists of 2 parts: 1) the in life part in mice and 2) analysis of the mice derived samples. Part 2) is done under GMP and is the value reported in the specifications/CoA.
My question is related to part 1) in life part in mice. What are the quality standards to be applied, is GLP mandatory?
Could you please provide any guideline as reference (EU, US)?
Thank you very much!