EU GMP Annex 1 Update: Enhancing Contamination Control Strategy

The European Medicines Agency (EMA) has released an updated version of EU GMP Annex 1, focusing on the Manufacture of Sterile Medicinal Products. This update, effective from August 25th, 2023, introduces significant changes to the regulatory landscape of sterile manufacturing, with an emphasis on risk assessment and management to prevent contamination.

Key Highlights of the Update:

• Stronger focus on risk assessment and management to prevent contamination.
• Increased importance of supplier and vendor qualification in developing Contamination Control Strategies (CCS) for products.
• Introduction of requirements for Single-Use Systems (SUS) and their providers.

While this landing page provides valuable insights into the regulatory changes, we encourage you to learn more about Venair's comprehensive support for Annex 1 implementation by downloading our detailed PDF document. This PDF contains essential information about how Venair's solutions align with the updated requirements, ensuring your continued success in compliant manufacturing.

Stay ahead of regulatory changes with Venair as your trusted partner in contamination control.