Analytical Quality Control News

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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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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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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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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FDA Warning Letter: Missing Method Validation - From a QC Topic to a Market-Access Problem

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter to a drug manufacturing facility in South Korea, illustrating how missing method validation can rapidly escalate from a QC topic to a broader compliance, supply, and market-access issue.

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WHO Working Document on Bioequivalence open for Public Consultation

A new WHO draft working document "Bioequivalence for Immediate Release Oral Dosage Forms" (QAS/25.990) is currently open for public consultation. It is intended to update WHO’s recommendations for demonstrating bioequivalence (BE) for orally administered immediate-release (IR) products such as tablets, capsules and oral suspensions. Comments can be submitted until 23 June 2026

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PharmaLab 2026: AQCG Organises Pre-Conference and APLM Track

PharmaLab has been the annual event for all areas of pharmaceutical laboratory development for 13 years. With the 14th PharmaLab Congress, it will move to a new venue: the “Darmstadtium”, the Congress Center of the “Science City Darmstadt”, located close to Frankfurt International Airport. This year, the ECA Analytical Quality Control Group (AQCG) will organise one of the pre-conferences and a dedicated one-day conference track on Analytical Procedure Lifecycle Management (APLM).

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LCGC Article on Analytical Procedure Lifecycle Approaches

In a new article published in LCGC International, Amanda Guiraldelli Mahr (AQCG Board Member), Jean-Marc Roussel, and Luis Flores Ortiz explain how ICH Q14 and ICH Q2(R2) are reshaping analytical procedures through a lifecycle approach centered on the Analytical Target Profile (ATP).

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