Abstract
The regulation of the manufacturing of cellular therapy products and vectors is under the auspices of the Food and Drug Administration (FDA) in the United States. For cells that are more-than-minimally manipulated, the regulations require that manufacturing is performed according to current Good Manufacturing Practices (cGMPs) (1). To ensure compliance the FDA sends out inspectors to audit manufacturers of both cGMP products and producers of Human Cells, Tissues, and Cellular and Tissue-Based products (HCT/Ps) (2). The latter are inspected for current Good Tissue Practices (cGTPs). This chapter recommends procedures to be followed when an audit is performed by a regulatory authority.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Similar content being viewed by others
References
Code of Federal Regulations. Drug good manufacturing practices (GMP). Title 21, Parts 210 and 211. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=210https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=211. Last accessed 13 July 2020.
Code of Federal Regulations. Human cells, tissues, and cellular and tissue-based products, Title 21 Part 1271. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=127. Last accessed 13 July 2020.
CBER. (2010). Compliance program guidance manual chapter – 45 biological drug products inspection of biological drug products 7345.848. https://www.fda.gov/media/73834/download. Last accessed 13 July 2020.
Federal Drug Administrations. (2008). Guidance for industry: CGMP for phase 1 investigational drugs. https://www.fda.gov/media/70975/download. Last accessed 13 July 2020.
U.S. Department of Health and Human Services Food and Drug Administration. (2004). Guidance for industry: Sterile drug products produced by aseptic processing—Current good manufacturing practice. September 2004. https://www.fda.gov/media/71026/download. Last accessed 13 July 2020.
European Medicines Agency. Human regulatory, good manufacturing practice. https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice. Last accessed 13 July 2020.
European Commission. (2017). Good manufacturing practice guidelines on good manufacturing practice specific to advanced therapy medicinal products. https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2017_11_22_guidelines_gmp_for_atmps.pdf. Last accessed 13 July 2020.
European Medicines Agency. Eudra GMDP Website. Compliance with good manufacturing practice. http://eudragmdp.ema.europa.eu/inspections/gmpc/index.do. Last accessed 13 July 2020.
Food and Drug Administration. Pre-operational reviews of manufacturing facilities. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/field-management-directives/pre-operational-reviews-manufacturing-facilities. Last accessed 13 July 2020.
Acknowledgments
This work was supported in part by a Core Grant (RP180785) from the Cancer Research and Prevention Institute of Texas.
I would like to thank Sara Richman of the center for Cell and Gene Therapy for reviewing this chapter.
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2022 Springer Nature Switzerland AG
About this chapter
Cite this chapter
Gee, A.P. (2022). FDA Inspections. In: Gee, A.P. (eds) Cell Therapy. Springer, Cham. https://doi.org/10.1007/978-3-030-75537-9_8
Download citation
DOI: https://doi.org/10.1007/978-3-030-75537-9_8
Published:
Publisher Name: Springer, Cham
Print ISBN: 978-3-030-75535-5
Online ISBN: 978-3-030-75537-9
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)