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...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
| Published: |
Universidade de São Paulo
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| Series: | Brazilian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.scielo.br/scielo.php?script=sci_arttext&pid=S1984-82502016000100012&lng=en&tlng=en |