Analytical Quality Control News

In the Pharmacopeial Forum, PF 51(1), a Stimuli article entitled "Characterization of Apex Vessel Geometries and Irregularities" was published. Apex vessels, previously referred to as PEAK vessels, are commonly used in dissolution experiments with Apparatus 2. The study highlights the importance of understanding the geometric variability of apex vessels and its potential impact on dissolution results.

The U.S. Food and Drug Administration (FDA) has published two new documents: a draft guidance referred to as "Considerations for Complying with 21 CFR 211.110" and a final guidance for industry titled "Advanced Manufacturing Technologies Designation Program."

The EDQM has announced the addition of a new FAQ to its existing series, addressing the system suitability test (selectivity) in chromatographic assay procedures. This update comes in response to user inquiries received via the HelpDesk.

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a Chinese OTC manufacturer based on a review of records. As seen in other recent FDA Warning Letters reported in the ECA newsletters, the cited violations include issues with identity testing, specifications, stability testing, and quality unit oversight.