Particulate and microbial contamination are among the leading causes of FDA recalls and have the potential to cause adverse effects for patients. The European Medicine Agency recently issued a revision of the Annex 1 of Good Manufacturing Practices aiming at improving patient safety, but this puts pharmaceutical manufacturers under pressure to meet these increasing quality standards.
In this webinar, our experts will explain how these new guidelines may impact your industrial strategy, its scope including sterile primary packaging suppliers and the role that closure components manufacturers must play to support your compliance to EMA GMP Annex 1.
Our experts will show how Aptar Pharma’s solutions already help you meet new Annex 1 guidelines related to:
- Establishing a Contamination Control Strategy for mitigating the risks of particulate and microbial contamination
- Adopting best practices regarding aseptic transfer of components on filling lines
- Guaranteeing sterility of primary packaging components at the time of use
Join us for getting ahead of your Contamination Control and compliance with EMA GMP Annex 1 revision guidelines.
Key Learning Objectives
- Understand the context and scope of the EMA Annex 1 Revision
- Learn about the role of suppliers and Primary packaging within Annex 1
- Discover Aptar Pharma’s solutions to help drug manufacturers address Annex 1
