MIAS assists companies with their MAA application by providing a QP Declaration to substantiate their submission. As MIAS holds Manufacturer’s and Importer’s Authorisations (MIAs) we are often named as both Site of Batch Release and as the party with responsibility for Product Defects and Recalls.
“A QP declaration is a written document that provides formal confirmation for demonstrating compliance of the active substance manufacture with GMP requirements and that the manufacturer has relevant knowledge of the supply chain.”
To provide a QP Declaration the MIAS QP must confirm that the active substance has been manufactured in accordance with the detailed guideline on good manufacturing practice for active substances used as starting materials as required by Article 46(f) of Directive 2001/83/EC. This is generally done by either the QP carrying out a personal on-site audit or a review an audit conducted by a qualified third party.