Analytical Quality Control News

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FDA: New Draft Guidance on Impurities in Antibiotics

In mid-April 2026, a new draft guidance document entitled 'Establishing Impurity Specifications for Antibiotics' was published on the FDA website.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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USP plans new General Chapter on Supercritical Fluid Chromatography (SFC)

The United States Pharmacopeia (USP) plans a new general chapter on Supercritical Fluid Chromatography (SFC), covering principles, practical application, and guidance for experimental setup. A preliminary outline has been published and public comments are invited until 28 May 2026.

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Ph. Eur.: Updated Guidelines for analytical Balances now available

In April 2026, the updated texts of Ph. Eur. 13.1 were published and listed on the EDQM website under the Ph. Eur. section. These include, for example, the revised general chapter '2.1.7. Balances for analytical purposes'.

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FDA Warning Letter: Batch Release Without Appropriate Laboratory Evidence

The U.S. Food and Drug Administration (FDA) has published a new Warning Letter that refers back to an inspection at a Chinese drug manufacturing facility. At the center of the letter is an analytical compliance failure frequently cited in Warning Letters: release decisions without appropriate laboratory evidence.

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