STERIS presents a series of webinars that equip medicinal drug product manufacturers and industry stakeholders with information to better manage compliance with the newly released revision of EU GMP Annex 1 in contamination control strategy (CCS) development and documentation.
The presented topics cover a range of process activities, including identification of contamination risks and mitigation strategies critical for compliance with Annex 1. Additionally, the webinars present opportunities for quality and productivity improvement.
Annex 1 FAQs
To comply with Annex 1, pharmaceutical manufacturers are required to identify, review and update critical controls to ensure holistic confidence in the measures implemented for contamination prevention.
STERIS Life Sciences has answered a list of frequently asked questions related to implementation and evaluation of a contamination control strategy for Annex 1 compliance.
On Demand Webinars
Implementation of a Contamination Control Strategy for Compliance with Annex 1
This webinar presents an overview of the contamination control strategy (CCS) process in a medicinal production facility. We introduce the European Compliance Academy (ECA) template as a tool for documenting the CCS process with examples of elements to consider, including cleaning, decontamination, sterilization and sterility maintenance.
The webinar also covers an overview of Annex 1 changes in contamination control and a discussion of challenges manufacturers may face with the holistic CCS approach. We discuss how to leverage modern technology (e.g., software, virtual reality) and statistical analysis to overcome these challenges. Finally, attendees will participate in a survey to share their experience and benchmark status regarding Annex 1 implementation.
