Analytical Quality Control News

FDA Publishes Draft Guidance on Potency Testing of Active Immunotherapy Products

In August 2026, the U.S. Food and Drug Administration (FDA) published draft guidance on potency testing for Active Immunotherapy Products (ACTIMPs). It is intended for manufacturers and sponsors who must ensure the consistent efficacy of active immunotherapies throughout the entire product lifecycle. The draft is non-binding and is initially being issued for public comment.

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USP-NF Publishes Responses to Comments on Stimuli Article on Apex Vessel Geometries

In the Pharmacopeial Forum, PF 52(5), the USP has published its responses to comments on the Stimuli article “Characterization of Apex Vessel Geometries and Irregularities”. The original article examined the geometrical characteristics and irregularities of commercially available apex vessels used with USP Apparatus 2 in dissolution testing. The responses indicate that further studies are planned before scientifically justified specifications and tolerances for apex vessels can be established.

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USP Article: Supporting the Detection of Asbestos in Pharmaceutical Talc

The USP has published an article on the implementation of current requirements for asbestos testing in pharmaceutical talc. The article provides an overview for manufacturers, suppliers and contract testing laboratories.

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New USP Requirements for Asbestos Testing in Pharmaceutical Talc

Since 1 June 2026, the revised USP Talc monograph has been official. Both X-ray diffraction (XRD) and polarized light microscopy (PLM) are now mandatory for the USP test for asbestos in pharmaceutical talc. However, many companies still face practical implementation challenges.

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FDA Warning Letter: Averaging Data to Override OOS Findings

A recent FDA Warning Letter to a US veterinary drug manufacturer reveals a pattern of out-of-specification (OOS) mismanagement. Confirmed OOS results were overridden by averaging retest data, specifications were changed by hand to accommodate failures, and products were distributed regardless. Additional findings cover the use of raw materials beyond their retest dates and the absence of formal validation protocols and reports.

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ECA's Analytical Control Group Publishes Detailed Report on OOS Survey

As previously reported, the ECA Analytical Quality Control Group (AQCG) conducted a survey on Out-of-Specification (OOS) results. Following the recent publication of a short summary, a detailed report is now available, complemented by a recorded video discussion highlighting key findings. Both are available free of charge in the group's members' area.

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BP Publishes Key Insights on Limits in Chromatographic Tests

The British Pharmacopoeia (BP) has published a new "Key Insights" article focusing on the topic of limits in common BP monograph tests, specifically chromatographic limits in related substances tests and assay.

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BioPhorum Publishes a Roadmap for QC Sample Test Execution

BioPhorum has published a new paper, “Sample test execution: Strategic guidance for advancing digital maturity”, addressing the following gap: many QC laboratories have not progressed through digital transformation as consistently as manufacturing, which can limit efficiency and slow batch release to patients.

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Several FDA Warning Letters and Untitled Letters on Asbestos Testing of Talc in OTC Drug Products

The U.S. Food and Drug Administration (FDA) has recently published several Warning Letters and Untitled Letters to OTC drug manufacturers, highlighting deficiencies in asbestos risk control for talc-containing products. FDA cites insufficient testing programs and inadequate monitoring to ensure talc is appropriately verified for quality and the absence of asbestos.

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USP AISQ Virtual Workshop: ECA AQCG Board Members Contributed as Speakers

In late June, the USP hosted a virtual “Analytical Instrument and System Qualification (AISQ)” workshop. Members of the ECA Analytical Quality Control Group (AQCG) Advisory Board contributed to the program as speakers.

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