GMP: New IMPD Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials

The application to carry out a clinical trial (Investigational Medicinal Product Dossier, IMPD) is a document which must contain all the relevant quality information regarding the manufacture, testing and packaging of APIs as well as of investigational medicinal products. The new guidance document applies to proteins, polypeptides, their derivatives, and conjugates.