By Patrick Hutchins and Mike Dingle
Regulatory requirements do not change regardless of the scale of the operation. However, if scale up includes distribution to additional geographical regions, additional or different requirements may need to be met. In the United States (US) market, you must follow the Food and Drug Administration (FDA) Aseptic Processing Guide. Most other markets are guided by the harmonized Annex 1 of the European Union (EU), Pharmaceutical Inspection Co-operation Scheme (PIC/S), and World Health Organization (WHO) Good Manufacturing Practices (GMPs).
To meet immediate vaccine demand, aseptic manufacturing capacity must increase quickly. This means environmental monitoring programs must adapt rapidly as well. Thoughtful planning can help.