Determination of the worst case for cleaning validation of equipment used in the radiopharmaceutical production of lyophilized reagents for 99mTc labeling

ABSTRACT Cleaning validation, a requirement of the current Good Manufacturing Practices (cGMP) for Drugs, consists of documented evidence that cleaning procedures are capable of removing residues to predetermined acceptance levels. This report describes a strategy for the selection of the worst case...

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Main Authors: Luciana Valéria Ferrari Machado Porto (Author), Neuza Taeko Okasaki Fukumori (Author), Margareth Mie Nakamura Matsuda (Author)
Format: Book
Published: Universidade de São Paulo.
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3rd Floor Main Library

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Call Number: A1234.567
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