PROCESS VALIDATION MAINTENANCE
This article was originally published in The Gold Sheet
...after product approval is drawing close scrutiny from FDA’s Team Biologics as part of its intensified GMP inspection program. Of concern are how deviations and changes in a manufacturing process are handled and their implications on the validation status of that process. Process validation problems have been found to be particularly acute for older products such as vaccines, although newer biotech products are also getting attention where there is a lack of consistent process performance or unapproved changes. [A discussion by CBER compliance officials of -- validation and post-approval changes, and -- reprocessing, reworking, and blending is included in a box beginning on p. 19.]
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