Sensors for GMP Environments: Compliance with GAMP 5 - Part 11 & Annex 11

The goal of process analytical technologies (PAT) is to make production processes reliable through real-time process monitoring and control. In bioprocesses for medicines as e.g. monoclonal antibodies (mAb) or viral vaccines production, “reliable” means that the process sensors have to be compliant with the Good Manufacturing Practices (GMP) guidelines.

As stated by the International Society for Pharmaceutical Engineering (ISPE): “Although the responsibility for compliance with GMP regulations lies with the regulated company, the supplier may have considerable involvement in the process”. This webinar will provide an overview about how Hamilton Process Analytics supports regulated companies' efforts with its GMP ready products and services.

What you'll learn:

• The regulations and guidance applying to process analytical solutions
• GAMP 5 and computerized systems: what are we talking about?
• How GMP users can leverage suppliers along the DQ-IQ-OQ-PQ sensor’s lifecycle
• Examples of product and services ready for Part 11/ Annex 11 compliance