Abstract
Good Manufacturing Practice (GMP) is sometimes forgotten until a production process has been developed, and on occasion is ignored until a plant is built and ready to run. This is in part caused by a tendency to view GMP as a nuisance, as something forced on the scientist or engineer by regulatory authorities. The aim of this article is to run through the outlines of a GMP code, emphasising those points most relevant to cell culture, and bringing out the ways in which the manufacturer can benefit by GMP compliance.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsPreview
Unable to display preview. Download preview PDF.
References
Code of Federal Regulations. Volume 21. General Service Administration. Washington DC. (1987) (published annually)
Harrison, F.G. Current Good Manufacturing Processes for BioTechnology — Oriented Companies. BioTechnology 3 43–46
Petricciani, J.C., P.L. Salk, J. Salk and P.D. Noguchi. Theoretical Considerations and Practical Concerns Regarding the Use of Continuous Cell Lines in the Production of Biologics. In Developements In Biological Standardisation, 50, 15–25, S. Karger, Basel (1982).
Tetzlaff, R.F. Regulatory Aspects of Aseptic Processing. Pharmaceutical Tchnology 8 38–44 (1984)
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1989 Kluwer Academic Publishers
About this chapter
Cite this chapter
Edy, V.G. (1989). Good Manufacturing Practice in the Production of Biologicals by Cell Cultures. In: Miller, A.O.A. (eds) Advanced Research on Animal Cell Technology. NATO ASI Series, vol 156. Springer, Dordrecht. https://doi.org/10.1007/978-94-009-0875-8_10
Download citation
DOI: https://doi.org/10.1007/978-94-009-0875-8_10
Publisher Name: Springer, Dordrecht
Print ISBN: 978-94-010-6881-9
Online ISBN: 978-94-009-0875-8
eBook Packages: Springer Book Archive