Analytical Quality Control News

USP publishes Comments rereived on Chapter <317>

In its recently published USP-NF 2026 Issue 1 Commentary (posted 25 July 2025), the United States Pharmacopeia (USP) addressed public comments received on the draft of General Chapter <317> ICP-OES Testing for Sodium Hydroxide and Potassium Hydroxide.

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EMA publishes Overview of Comments received on ICH M13B Guideline on Bioequivalence

On 25 July 2025, the European Medicines Agency (EMA) published an overview of the comments received on the draft version of the new "ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b".

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FDA Warning Letter: Company Voluntarily Ceases Drug Production

In a recently published Warning Letter, the U.S. Food and Drug Administration (FDA) outlined systemic failures in stability testing, storage practices, material testing, finished product release, and water system control at a facility in Utah. During the inspection, the company voluntarily submitted a written statement indicating that it would discontinue the manufacturing of various drug products.

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WHO: TRS 1060 Nitrosamine Guideline published

In April 2025, the WHO published the new guideline ‘TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products’ on its website, which must be taken into account by manufacturers and packagers of excipients, active ingredients, processing aids and finished medicinal products. It should be noted that WHO Annex 2 is to be regarded as a supplement to the existing GMP guidelines and their requirements with regard to nitrosamines, as set out, for example, in ICH M7 (R2).

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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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