PP 37/19Certification by a Qualified Person and Batch Release

EIGA’s Medical Gases Council has revalidated a Position Paper concerning the requirements for Qualified Persons (QP) in EIGA member medicinal gas production facilities.

European and national regulations are currently interpreted in different ways by various Member States and this interpretation leads to different demands and various implementation models, such that the structure and organisation of these QPs within the European regions has become complex and inconsistent. 

The attached Position Paper establishes the EIGA position which is that QPs in the medicinal gas industry should be allowed to certify product remotely and for more than one site.

The Position Paper will be used to communicate EIGA’s position in a public consultation on the Good Manufacturing Practices Annex 16 concerning QPs that has been opened by the European Medicines Agency (EMA).

This Position Paper was re-validated in December 2019.