Analytical Quality Control News

EMA: Stability Data for Variations - Update to the Guideline

In December 2025, Revision 3 of the 'Guideline on stability testing for applications for variations to a marketing authorization' was published on the EMA website. It entered into force on 15 January 2026.

More
EDQM: New General Chapter 'Quality of Data' available

The new general chapter '5.38. QUALITY OF DATA' was made available in January with the release of version 12.3 of the European Pharmacopoeia (Ph. Eur. 12.3). This new chapter was open for public comment in 2024 and is scheduled to come into force in July 2026.

More
Become a Speaker at PharmaLab 2026 - Analytic, Bioanalytic, Microbiology

PharmaLab 2026 - become a speaker at the leading congress on analytics, bioanalytics and microbiology. Meet over 500 colleagues as part of the speaker team in Darmstadt (near Frankfurt Airport). We also welcome poster requests.

More
FDA Warning Letter: OOS Handling and HPLC Method Validation

When out-of-specification (OOS) laboratory results are explained rather than thoroughly investigated, and HPLC methods are not demonstrably fit for purpose, regulatory action may follow. A recent FDA Warning Letter highlights how recurring weaknesses in OOS handling and analytical method validation can result in significant CGMP compliance risks.

More
Eurachem Publishes New Guide on the Fitness for Intended Use of Analytical Equipment and Systems

Eurachem has published a new Guide titled The Fitness for Intended Use of Analytical Equipment and Systems – A Laboratory Guide to the Life Cycle of Analytical Equipment and Systems, their Qualification and Related Topics. The document addresses the entire life cycle and qualification of analytical equipment and systems used in laboratories, ranging from simple apparatus to complex computer-based systems, and promotes an integrated, risk-based approach to ensure fitness for intended use.

More
Analytical Quality Group Developments September through December 2025

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

More
Revised Ph. Eur. Chapters 2.9.42 and 2.9.43 on Dissolution Testing

In Pharmeuropa, the “Comments concerning texts published in Issue 12.3” were published. These include explanations of the new, revised, and corrected texts adopted by the European Pharmacopoeia Commission, including Chapters 2.9.42 and 2.9.43 on dissolution testing.

More
Korean MFDS Publishes Data Collection on Dissolution Test Methods

The Korean Ministry of Food and Drug Safety (MFDS) has published a Dissolution Test Method Data Collection, which includes structured information on dissolution testing, comparisons with major pharmacopoeias, and a checklist for practical use.

More
FDA Warning Letter: 1,500 OOS Results with Numerous Inadequate Investigations

The U.S. Food and Drug Administration has issued a Warning Letter to an API manufacturing site in India. Since 2023, approximately 1,500 laboratory incidents (including OOS results and major analytical events) have been recorded, and the authority identified systemic failures in the handling of Out-of-Specification (OOS) results, laboratory investigations, and the overall CAPA system.

More
Questions and Answers on System Suitability Tests (SST) - Part 1

During the ECA Live Online Training “System Suitability Tests (SST) and Troubleshooting for HPLC Methods” on 04 November 2025, a number of interesting and practice-oriented questions were raised by the participants. These questions have been answered in writing by the speakers’ team after the event. To share some of the key insights with a broader audience, we have compiled a selection of these Q&As. Read Part 1 here.

More
x
Search