Analytical Quality Control News

BP Publishes new Draft Texts

The British Pharmacopoeia (BP) has published a new consultation period with 28 draft texts, including 6 new and 22 revised monographs. Comments can be submitted until 31 December 2026.

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FDA Identifies Critical Deficiencies in Analytical Testing and CGMP Oversight

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter concerning significant shortcomings in laboratory testing, supplier qualification, process validation and quality unit (QU) oversight. Particular concerns involved inadequate release testing, incomplete identity testing of incoming materials and insufficient control of the pharmaceutical water system.

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Bioassays in the United States Pharmacopoeia - Two Chapters come into Force in Spring

With the publication of chapters <1032> and <1034> on methods and statistics, the United States Pharmacopoeia continues its series of revised and new chapters in the field of bioassays.

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Analytical Quality Group Developments May through August 2026

Find out what the ECA Analytical Quality Control Group was working on and accomplished in the second four months of 2026 - in the latest report.

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Pharmeuropa: Revision Proposed for Chapter 2.5.32 on Coulometric Karl Fischer Water Determination

A draft revision of European Pharmacopoeia (Ph. Eur.) general chapter 2.5.32. Water: micro determination has been published in Pharmeuropa 38.4. The public consultation deadline is 31 December 2026.

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Two New FDA Warning Letters Put OOS Investigations in Focus

Two new FDA Warning Letters address, among other issues, significant deficiencies in out-of-specification (OOS) investigations. Both letters underline that retesting, procedural changes or a revised specification cannot replace a scientifically sound investigation, a detailed root cause analysis and an assessment of potential impact on other batches and products.

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New Japanese Pharmacopoeia Drafts (September 2026) Open for Public Comment

The Pharmaceuticals and Medical Devices Agency (PMDA) has published the second set of Japanese Pharmacopoeia (JP) draft texts for September 2026. The drafts include new monographs, natural drug monographs, and ultraviolet-visible and infrared reference spectra. Comments can be submitted until 30 November 2026.

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EMA publishes final ICH M13B Guideline and Q&A on Bioequivalence

The European Medicines Agency (EMA) has published the final  ICH M13B guideline on bioequivalence for immediate-release solid oral dosage forms - additional strengths biowaiver - Step 5, together with an accompanying Questions and Answers document.

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FDA Warning Letter: Deficiencies in Impurity Testing, Stability, OOS Investigations and Temperature Control

A new FDA Warning Letter highlights serious deficiencies in impurity testing, stability programmes, OOS investigations and warehouse temperature control at an OTC drug manufacturer in California.

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FDA Warning Letter: Deficiencies in Stability Testing, Supplier Qualification, Validation and CGMP Oversight

In a recently published Warning Letter, the FDA describes significant and repeated CGMP deficiencies at a U.S. manufacturer of over-the-counter (OTC) products. The observations concerned incoming material controls, stability testing, process and cleaning validation, quality unit oversight, and the implementation of previously committed corrective actions.

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