This presentation will provide an overview of health authority expectations for those within pharmaceutical, medical device and combination product operations to include manufacturing, environmental monitoring and analytical supporting operations. Current trend information resulting from recent health authority inspections and field actions will be presented as well as contributing root causes resulting in these observations. Primary focus will be referenced to the EU requirements (EudraLex – Volume 4, Good Manufacturing Practices), ICH Q10 (Pharmaceutical Quality System) and the U.S. FDA guidance for Aseptic Processing and Sterile Manufacturing.
The presentation will also include an overview of verification and validation concepts as required by health authorities (U.S. FDA and EU) providing a general overview of approach strategies for validation. Additional trend information as a result of recent health authority inspections will be presented.