Sensors for GMP Environments: Compliance with GAMP 5 - Part 11 & Annex 11
In this 30-minute webinar you will learn about:
- The Regulations and guidances applying to process analytical solutions
- GAMP 5 and computerized systems: what are we talking about?
- How GMP users can leverage on suppliers all along the DQ-IQ-OQ-PQ process sensor’s lifecycle
- Examples of product and services ready for Part 11/ Annex 11 compliance
The scope of process analytical technologies (PAT) is to make production processes reliable trough reliable real-time process monitoring and control. When this applies to bioprocesses such as the ones used to produce medicines as e.g. monoclonal antibodies (mAb) or viral vaccines, “reliable” means that the process sensors have to be compliant with the Good Manufacturing Practices (GMP) guidelines. In those regulated companies, computerized systems, such as pH, dissolved oxygen or viable cell density sensors, have to be developed, manufactured and implemented according to guidances like the Good Automated Manufacturing Practices (GAMP). This is the most concrete way to ultimately achieve the CFR 21 Part 11 or Eudralex Volume 4 Annex 11 compliance, all along the sensor’s DQ-IQ-OQ-PQ lifecycle.
Now as stated by the International Society for Pharmaceutical Engineering (ISPE): “Although the responsibility for compliance with GxP 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 through its GMP deliverables: products and services.
Giovanni Campolongo, Market Segment Manager Process Analytics