Analytical Quality Control News

New HPTLC Chapter Proposed for The International Pharmacopoeia

The World Health Organization (WHO) has published a new general chapter "1.18 High-performance thin-layer chromatography" (HPTLC) to be included in The International Pharmacopoeia. The draft is currently open for public consultation. Comments can be submitted via the WHO platform until 09 September 2025.

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Analytical Quality Group Developments January through April 2025

Find out what the ECA Analytical Quality Control Group was working on and accomplished in the first four months of 2025 - in the latest report.

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ICH publishes Training Materials on Q2(R2) and Q14

On 8 July 2025, the ICH published Training Modules 1 to 7 on ICH Q2(R2) “Validation of Analytical Procedures” and ICH Q14 “Analytical Procedure Development.” The files are available for download on the ICH website.

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Free Webinar on Sampling and Sample Management: Recording & Q&A Document

A free one-hour webinar on ECA’s new Guidance on Sampling and Sample Management was held on 17 June 2025 for all members of the Analytical Quality Control Group (AQCG). After the event, the speaker, Dr Christopher Burgess, answered the submitted questions in writing. The resulting Q&A document, containing 39 questions and answers, is now available in the members’ area. If you haven’t seen it yet: the webinar recording and presentation slides are also accessible.

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AQCG welcomes two new Board Members

The ECA Analytical Quality Control Group (AQCG) is pleased to announce recent changes to the Board. As of June 2025, Dr Amanda Guiraldelli Mahr has joined the Board. Lance Smallshaw has been serving as a member since November 2024.

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AQCG Organises One-Day Track at PharmaLab 2025

PharmaLab Congress – the event for all pharmaceutical laboratory sectors – will take place from 24–26 November 2025 in Düsseldorf/Neuss. This year, the ECA Analytical Quality Control Group (AQCG) will organise a dedicated one-day conference track. The draft programme is now available.

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Inadequate Sampling and Component Testing Highlighted in FDA Warning Letter

An FDA inspection revealed serious CGMP violations related to sampling, testing, and quality oversight at a U.S.-based drug manufacturer, underscoring the critical importance of scientifically sound sampling strategies.

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EMA publishes new Product-Specific Bioequivalence Guidance

The European Medicines Agency (EMA) has added new entries to its “Product-specific bioequivalence guidance” section, publishing updated guidelines for individual products.

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Revision of USP Chapter <1039> Chemometrics Published for Comments

In Pharmacopeial Forum 51(4), the USP has published a major revision of General Chapter <1039> Chemometrics for public comment. The update reflects the rapid evolution of the field, particularly driven by developments in machine learning and AI.

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Proposal for new USP Chapter <318> NMR Monomer Ratio Determination for Lactide-Glycolide Polymers

In the Pharmacopeial Forum, PF 51(4), a proposal for a new USP General Chapter <318> Nuclear Magnetic Resonance Spectroscopy Monomer Ratio Determination for Lactide–Glycolide Polymers has been published for public comment. Developed by the Excipients Test Methods Expert Committee, the chapter introduces a validated proton NMR method to quantify the monomer ratio in ring-opening copolymers of DL- or L-lactide and glycolide.

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