Getting you ahead of annex 1 7.2
Annex 1 of the EU GMP guidelines, “Manufacture of Sterile Products,” is a critical document that outlines the regulatory expectations for sterile manufacturing processes.
Maximizing Compliance, Safety, and Efficiency: The Importance of Monitoring Maximum Capacity in Clean Rooms
Maintaining the integrity of clean rooms is critical for industries such as pharmaceuticals, biotechnology, and semiconductors. These controlled environments are essential for ensuring product quality and compliance with stringent regulatory standards.
White Paper: Human Contamination and Controlled Access in Clean Room Environments – Compliance with Annex 1, Paragraph 7.2
The critical issue of human contamination in clean room environments, with a focus on compliance with Annex 1, Paragraph 7.2, of the European Union Guidelines to Good Manufacturing Practice (GMP). Personnel represent a significant contamination risk in sterile manufacturing, introducing both viable and non-viable particles into controlled environments. Annex 1 mandates stringent access control to mitigate these risks, including minimizing personnel in clean rooms and tracking entry and exit points.
