FDA updates guidance on evaluating out-of-specification results for drugs The US Food and Drug Administration (FDA) has revised its 16-year-old final guidance on procedures for reviewing ...
Susan J. Schniepp, distinguished fellow at Nelson Labs, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, provide advice on creating a robust out-of-specification procedure. Welcome to ...
In-house harmonization of excipient specifications ensures compliance with multiple pharmacopoeias, reducing redundant testing and aligning with global regulatory expectations. Specification ...
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