Analytical Quality Control News

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.

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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.

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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.

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China: NMPA publishes Draft Guidance on Inspection of Data Integrity in QC Laboratories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Medical Products Administration (NMPA) – through the Centre for Drug Evaluation and Inspection (CDEI) – has released a draft guidance for public comment on the inspection of data integrity in pharmaceutical quality control laboratories.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.

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EMA updates Q&A on Reduced Testing of Incoming Starting Materials

The European Medicines Agency (EMA) has published an update to its “Quality of medicines: questions and answers – Part 2”. The update focuses on the section “Reduced testing of incoming starting materials”.

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BP Publishes Key Insights on Chromatography and SST

The British Pharmacopoeia (BP) has published so-called “Key Insights” focusing on chromatography in the BP and selected system suitability test (SST) requirements described in the chapter “Chromatographic Separation Techniques”. The article covers system suitability requirements in Chromatographic Separation Techniques (CST), peak symmetry, and system sensitivity.

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How are Reference Standards used in the Pharmaceutical Industry?

The use of reference substances is a key component of pharmaceutical analysis and quality assurance. Reference substances (or reference standards) play a crucial role in ensuring the safety, harmlessness and efficacy of medicinal products. Find out more on how reference substances are used in the pharmaceutical industry.

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Endotoxin Test – Updated FDA Q&A document published

With the publication of a revised Q&A guide, the FDA is responding to the recommendations on endotoxin testing set out in USP chapters <85> and <161> and in the AAMI guidelines for medical devices.

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FDA: New Draft Guidance on Impurities in Antibiotics

In mid-April 2026, a new draft guidance document entitled 'Establishing Impurity Specifications for Antibiotics' was published on the FDA website. Comments on this 'Guidance for Industry' can now be submitted until 22 June 2026.

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What is meant by Good Documentation Practice?

Documentation fulfils several key functions within the GMP environment and is an indispensable component of quality assurance. This raises the question: what exactly is meant by the term 'Good Documentation Practice'?

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