FDA Guidance Document addresses sterility issues
If you make a sterile medical product, and you want to avoid sterility testing by instead confirming container and closure system integrity, the Food and Drug Administration has prepared a written Guidance Document just for you. The FDA Guidance Document on the subject has been in draft form since 1998, and was made final in February 2008.
Oct 22, 2008
FDA warning letters surge - is your team prepared?
New guide reveals expert strategies to prevent regulatory issues and respond effectively to FDA enforcement actions in pharmaceutical and medical device manufacturing.
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