What Does The New Annex 1 Mean For The Aseptic Fill/Finish Industry?

The revised Annex 1 regulation has prompted the pharmaceutical industry to strategize on the best compliance methods. The Annex provides general guidance that should be used in the design and control of facilities, equipment, systems, and procedures used to manufacture all sterile products applying the principles of Quality Risk Management. The regulations outlined in Annex 1 cover various sterile product types and processes, aiming to prevent various types of contamination in the final product. The 2023 version of Annex 1 introduced the term Contamination Control Strategy (CCS) and emphasized the importance of unidirectional airflow and the "First Air" principle. Annex 1 recommends the use of barrier technology, specifically isolators, due to their effectiveness in providing a low-risk environment for drug production. The regulation also expands on environmental monitoring and encourages automation to reduce the risk of decontamination. Learn more about how the new Annex 1 represents significant progress towards harmonizing regulations across the pharmaceutical manufacturing industry, emphasizing the vital roles of automated and barrier technology in ensuring medicinal production safety and quality.