ISPE

SEPTEMBER 8, 2023

Attendees were invited to submit questions to the FDA representatives. 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. How will the FDA use Annex 1 in its final version?

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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

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. EU human tissues and cells directive 2004/23/EC; 7.

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Vaccines Compounding Documentation FDA 97

ISPE

AUGUST 30, 2022

Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). A formal change control system under the company’s pharmaceutical quality system (PQS) is required to evaluate all raw material changes, with established procedures for identification, documentation, review, and approval.

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Documentation FDA Packaging Communication 52