On Demand
Viable Monitoring to Include in a CCS for Annex 1
Contamination control in aseptic processing is important for Annex 1 but is complicated. This webinar reviews the GMP expectations and answers audience questions.
Annex 1 gives us guidelines that we should apply to a Contamination Control Strategy (CCS) in asepetic processing (including a cleanroom monitoring plan). Annex 1 has some critical changes that are important to understand and start applying. While the drafts cover many areas of environmental monitoring in-depth, this webinar by Particle Measuring Systems (PMS) experts focuses on the Viable/Microbial Air Monitoring aspects including:
- Designing an effective Contamination Control Strategy (CCS) based on a scientific assessment to understand the process and to apply risk management principles.
- Newest Annex 1 Single Use Requirements relevant solutions
- Microbial Plate Incubation and Pharmaceutical Risk Assessments
- Importance of Continuous Viable Air Monitoring
- How the underlying need of a Quality Risk Management (QRM) approach, along with Risk Assessments based on science are to be the fundamental principles driving decisions to protect product quality
- When, Where, and How to do Environmental Monitoring and a cleanroom monitoring plan.
- Changes in Viable Monitoring Requirements
- Solutions to meet these cleanroom monitoring requirements
- Concepts regarding the requirements for a Pharmaceutical Risk Assessment to set appropriate Microbial Plate Conditions
- Much more!
During the live webinar we had several questions submitted and made these into an Annex 1 Microbial FAQ paper that you can access at any time.
