Guidance on visible particulates in products intended for parenteral administration
This standard provides guidance on QC processes for all products intended for parenteral administration (i.e., injection), including the need for 100% visual inspection, without magnification, and conformance with an Acceptable Quality Limit (AQL) of ≤ 0.65% at batch release.
Specifically, USP <790> mandates that products must be visually inspected for—and essentially free of—the presence of particulate matter as defined in USP <788>. Examples of visible particulate matter include fibers, glass, metal, elastomeric materials and precipitates.
Where the nature of the contents/container enables only limited capability for inspecting contents, 100% inspection of a batch must be supplemented with an inspection of constituted (e.g., dried) or withdrawn contents of a sampling of containers from each batch. Containers showing evidence of visible particulates must be rejected.