When manufacturing an Advanced Therapy Medicinal Product (ATMP) it is important to pay attention to the choice of raw materials used. These influence the entire process, from Investigational Medicinal Product Dossier (IMPD) to market authorization. Good Manufacturing Practice (GMP) guidelines contain important considerations, but what does this mean in practice for the ATMP manufacturer? How to take into account the origin, traceability and composition of the raw materials? How to collaborate with a supplier in the audit process of these raw materials?
at.las, eyetec and anicells are pleased to offer you a GMP audit checklist for the qualification of suppliers and their products.
This document supports an ATMP manufacturer to assess its suppliers, which is a legal obligation in EU GMP Part IV.
Download your copy below.
