Continuous Manufacturing and GMP Compliance – yes but how? (10587)

On 16th November 2022 the International Council for Harmonisation (ICH) published the Q13 guideline for Continuous Manufacturing for APIs and finished product. This guideline expands the draft of the FDA Center for Drug Evaluation and Research (CDER) concerning quality considerations for continuous manufacturing (CM). In this draft the FDA see Continuous Manufacturing as a chance for the industry to improve the experiences with the manufacturing process and to improve the process controls.

The realization of CM referring to equipments and technology is the one side, but how to realize it from the GMP-compliance point of view is the other side. In this course we will have a detailed look into the ICH Q13, as well as into the requirements by the FDA. Examples from the guidelines and from equipment manufacturers will be presented and discussed. You can check your knowledge about CM during the course with many Multiple Choice Questions. 

Key aspects:

• Overview about the GMP-compliance requirements for CM 
• Detailed look into the new ICH Q13 
• Overview of the FDA requirements
• The batch term in CM
• Handling of disturbances during the CM
• Meaning of research and development for CM
• Monitoring and PAT during the CM process
• Meaning of CM in presence and future
• Many examples from the guidelines and from manufacturers
• Check of CM knowledge with many Multiple Choice Questions

Duration of the recording: approx. 90 minutes
Lecture language: English | Slides: English

...your speaker Dr. Felix Kern...

If this training is of interest to multiple colleagues in your teams, please contact us. For group trainings we offer favorable scale prices.

Note on quota call-off: When booking this single part described here, one part per trained person will be deducted.