Where high-care areasare part of the manufacturing site there should bephysical segregation between these areas and other parts of the site. Segregation shall take into account the flow of product, nature of materials, equipment, personnel, waste, airflow, air quality and utilities provision. Where physical barriers are not in place, the site shall have undertaken a full evaluation of the risks of cross-contamination and alternative effective processes shall be in place to protect products from contamination.