Author: Pascal Puig, CMC-RA Director at Eurofins CDMO
Sometime it is good to go back to basics, knowing that everything is not carved instone with early phase IMPs.
This whitepaper does not impose mandatory commandments but presents warm recommendations. For IMPs in clinical trials we should refer to the EMA guidelines on the requirements for Quality documentation. There is one guideline for ChemicalsIMPs and another for Biologicals IMPs.
Generally we already apply them, since there are simpler and more flexible than the ICH guidelines about stability (ICHQ1 series and ICH Q5C) which apply to pre-marketing authorization or marketed medicinal products.
