TGA expectations for overseas manufacturing sites hosting remote inspections during the COVID-19 pandemic
(WorldNews Politics)

The COVID-19 pandemic has had a significant impact on regulatory bodies and business organisations around the world. Travel restrictions and ensuring a safe working environment for all staff currently prevents face-to-face on-site overseas GMP inspections from being conducted. Industry and regulatory bodies need to work together to help maintain appropriate regulatory oversight of GMP activities to ensure the continued quality, safety efficacy and continuity of supply of therapeutic products and services to protect patients. Following the publication of the GMP approach to overseas manufacturers of medicines and biologicals during the...