Using an eDMS to enable EU-compliant batch release of medicinal products

Annex 16 of the European Union (EU) Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use provides detailed requirements for batch certification and release. A key stipulation for batch release by the Qualified Person is confirmation that the batch being released has been manufactured in compliance with the requirement of its marketing authorization, regardless of whether the batch is intended for patients within the EU or for export. Management of these registered details can be challenging, especially for complex supply chains, or when registered details differ between markets. One solution is to utilize an electronic document management system (eDMS) to store, organize, update and track registered details. The presentation will provide an overview of how an eDMS can be used to manage registered details in multiple markets to enable compliance with Annex 16 expectations.