Analytical Quality Control News

WHO Draft Guidance: Selecting the Right Analytical Screening Technologies for Substandard and Falsified Medicines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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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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ECA AQCG OOS Survey: A First Short Summary

How does your organisation handle OOS results in practice? The ECA AQCG conducted a survey and received 169 responses. Read a first short summary here.

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