ISPE

OCTOBER 26, 2022

ATMP facilities are different from conventional pharmaceutical facilities that process other traditional modalities, such as vaccines and monoclonal antibodies (mAbs), and often require heightened segregation and smaller footprints. EU human tissues and cells directive 2004/23/EC; 7. Complete Data Gathering.

Vaccines 97

Vaccines Compounding Documentation FDA 97

ISPE

SEPTEMBER 8, 2023

A highlight of the session was the mutual praise from industry and regulators on how well the two parties worked together during the pandemic to bring vaccines and drugs to the patients in record time. The Emergency Use Authorization approval for the COVID-19 vaccines was a major success.

FDA 52

FDA Vaccines Documentation 52

ISPE

SEPTEMBER 11, 2023

September 2004. Distributed Manufacturing and Point-of-Care Manufacturing of Drugs.” “Sanofi Pumps $554M into New Vaccine Manufacturing Facility in Eastern France.” www.fiercepharma.com/manufacturing/sanofi-pumps-554m-into-new-vaccine-manufacturing-facility-eastern-france 41 Boccard. Journal of Pharmaceutical Sciences 111, no.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

AUGUST 30, 2022

During the pandemic, the pharmaceutical industry faced challenges in the production of COVID-19 therapeutics and vaccines to meet global demand, as well as mitigation of drug shortages for non-COVID-19-related products, without compromising product quality or patient safety. Additional requirements are described in ICH Q7.

Documentation 52

Documentation FDA Packaging Communication 52