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Panel points to USP chapter guidance for visual inspection of injectables
Summary
When asked which USP chapter covers visual inspection of injectables, the panel recommended starting with USP chapter 1790 (visible particulates) and USP chapter 1, and following references those chapters cite.
An online question asked which USP chapter covers visual inspection of injectables. Dr. Aldridge recommended starting with USP chapter 1790 for visible particulates and USP chapter 1 as a general starting place; the panelist noted those chapters will point to additional relevant material.
"If it's an injectable, start with 1790. You can also look at USP chapter 1," Aldridge said, adding that those sections are good places to begin and may refer users to other resources.
Why it matters: Manufacturers and reviewers rely on USP chapters to establish inspection criteria and acceptance thresholds for particulates and visible defects; identifying the right chapters helps sponsors prepare appropriate data for ANDA submissions.
