Analytical Quality Control News

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.

More
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.

More
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

More
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).

More
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).

More
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.

More
New Eurachem Guide on Measurement Uncertainty

Eurachem has published a new guide, “Evaluation of measurement uncertainty from in-house precision and recovery data”. Produced by a joint Eurachem/CITAC Working Group, the document provides practical guidance on using in-house method validation data to evaluate measurement uncertainty.

More
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.

More
FDA Warning Letter to EU OTC Manufacturer

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an EU-based OTC drug manufacturer (Czech Republic) after reviewing documents submitted after a request for records and other information. Key findings include missing incoming material identity testing, no stability program despite labeled expiry dates, inadequate process validation, insufficient method validation and microbiological control, and incomplete laboratory documentation.

More
China: NMPA publishes Draft Guidance on Inspection of Data Integrity in QC Laboratories

The Chinese National Medical Products Administration (NMPA) – through the Centre for Drug Evaluation and Inspection (CDEI) – has released a draft guidance for public comment on the inspection of data integrity in pharmaceutical quality control laboratories. The document highlights inspector expectations for data reliability (ALCOA++) in pharmaceutical quality control laboratories, covering governance, lifecycle data management, risk-based controls, and typical deficiencies in paper, computerized and hybrid environments.

More
x
Search