Compared to commercial medicinal products, the manufacturing of investigational medicinal products (IMPs) has certain particularities and additional requirements, for instance there are many manual process steps and there’s less routine. There are different study designs with verum, placebo and comparator products, the handling of randomization codes, blinding processes, the handling of returns, etc. and up to now not fully validated production processes. Our auditors have experience and are trained to take into account the special requirements for IMPs. Our audit approach is highly customized and takes into account our clients’ specific requirements, for instance the review of certain deviations, changes, complaints or studies.
