Viable Monitoring Solutions to Prepare Your Contamination Control Strategy (CCS) for ANNEX 1
While the new Annex 1 is still in draft stage, the drafts tell us clearly where the committee is heading as far as priorities and gives us guidelines that we can apply now to your Contamination Control Strategy (CCS) to be ready for the final Annex 1 update release. The New 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
- Changes in Viable Monitoring Requirements
- Solutions to meet these 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.