EN PL

EMA: Scientific guideline: Draft template for the Qualified Person’s declaration concerning GMP compliance of the active substance used as starting material and verification of its supply chain “The QP declaration template”, draft

14.01.2011
The objective of this Qualified Person (QP) Declaration Template is to emphasise the importance of providing a comprehensive declaration, to harmonise the format for the declaration, to forestall questions during assessment, and to enhance the efficiency of the regulatory process.