Abstract
Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act provides, in part, that a drug is adulterated if “the methods used in, or the facilities or controls used for its manufacture, processing, packing, or holding do not conform to current good manufacturing practice...” The Current Good Manufacturing Practice regulations, 21 CFR 210 and 211, or CGMP, convey requirements to ensure that all members of the drug industry, including those who make PET radiopharmaceuticals, are aware of the level of performance expected of them to be in compliance with the Act.
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
Preview
Unable to display preview. Download preview PDF.
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 1995 Springer Science+Business Media New York
About this chapter
Cite this chapter
Levchuk, J.W. (1995). Compliance with Good Manufacturing Practice. In: Emran, A.M. (eds) Chemists’ Views of Imaging Centers. Springer, Boston, MA. https://doi.org/10.1007/978-1-4757-9670-4_11
Download citation
DOI: https://doi.org/10.1007/978-1-4757-9670-4_11
Publisher Name: Springer, Boston, MA
Print ISBN: 978-1-4757-9672-8
Online ISBN: 978-1-4757-9670-4
eBook Packages: Springer Book Archive