Analytical Quality Control News

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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ECA AQCG OOS Survey: Detailed Report and Recorded Discussion Now Available

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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WHO Draft Guidance: Selecting the Right Analytical Screening Technologies for Substandard and Falsified Medicines

The World Health Organization (WHO) has published a new draft working document (QAS/26.1004, June 2026) titled "WHO Guidance on the Selection and Use of Technologies to Screen and Detect Substandard/Falsified (SF) Medicines", which is currently open for public consultation until 31 August 2026.

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Analytical Quality Group Developments January through April 2026

Find out what the ECA Analytical Quality Control Group was working on and accomplished in the first four months of 2026 - in the latest report.

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FDA Warning Letter: Deficiencies in Incoming Component Testing, Stability Program, and Data Integrity Controls

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturing facility in Illinois. The agency highlights three interlinked failures: insufficient incoming-material testing, lack of stability data to justify expiry, and data integrity / quality unit oversight weaknesses.

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What are the Requirements for Testing for Impurities in the Pharmaceutical Industry?

In the pharmaceutical industry, the management of impurities - in particular, control via suitable analytical methods and reporting requirements - is clearly regulated. The main requirements are set out in the ICH Q3B(R2) guideline. What are the requirements for testing for impurities in the pharmaceutical industry?

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EMA Provides an Outlook on the Product-Specific Bioequivalence Guidelines Expected in 2026

A new section has been added to the EMA website under “Product-specific bioequivalence guidance”, featuring a list of the product-specific guidance documents expected in 2026.

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