Analytical Quality Control News

China: NMPA publishes Draft Guidance on Inspection of Data Integrity in QC Laboratories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Medical Products Administration (NMPA) – through the Centre for Drug Evaluation and Inspection (CDEI) – has released a draft guidance for public comment on the inspection of data integrity in pharmaceutical quality control laboratories.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FDA: New Draft Guidance on Impurities in Antibiotics

In mid-April 2026, a new draft guidance document entitled 'Establishing Impurity Specifications for Antibiotics' was published on the FDA website.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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Laboratory Controls in Focus in FDA Warning Letter to U.S. OTC Manufacturer

The FDA has issued a new Warning Letter to an OTC drug manufacturer in Palm Bay, Florida. The agency cites significant CGMP deficiencies, with a strong emphasis on laboratory control and analytical oversight, including missing finished-product testing prior to batch release, weaknesses in incoming-material testing and supplier/COA qualification, an inadequate stability program, and inadequate QU oversight.

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IPEC: Updated Stability Guide for Excipients

At the end of March 2026, the IPEC announced the updated Version 3 of its 'Excipient Stability Guide for Pharmaceutical Excipients' in a notice on its website. This was first published in 2010 and is currently only available and viewable in the IPEC members' area. Following a three-month period (expected to end on 30 June 2026), the updated guide is to be published in full.

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Revised Chapter 2.8.25 HPTLC of Herbal Products” Published in Ph. Eur. 13.1

At the beginning of April, Issue 13.1 of the European Pharmacopoeia (Ph. Eur.) was published. It will be applicable as of 1 January 2027. Among other texts, it includes the revised general chapter 2.8.25 High-performance thin-layer chromatography of herbal products.

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