Analytical Quality Control News

Proposal for new USP Chapter <319> on NMR Block Length Determination

In Pharmacopeial Forum 52(1), a new USP General Chapter, <319> Nuclear Magnetic Resonance Spectroscopy Block Length Determination for Lactide–Glycolide Polymers has been published for comment..

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Which GMP Requirements Apply to Stability Studies in the Pharmaceutical Industry?

Stability studies are the scientific cornerstone for understanding how the quality of an active substance or medicinal product evolves over time when exposed to environmental factors such as temperature, humidity, and light. Thoughtfully designed and consistently executed stability programs are essential – not only to meet regulatory expectations, but also to support robust lifecycle management and enable confident, risk-based decision-making.

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New USP Stimuli Articles on Dissolution Testing

In the Pharmacopeial Forum, PF 52(2), two Stimuli articles addressing the mechanical performance qualification of USP Apparatus 3 (Reciprocating Cylinder) and USP Apparatus 4 (Flow-Through Cell) were published.

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FDA Warning Letter to US Manufacturer Highlights Laboratory Deficiencies

In a recent Warning Letter, the U.S. Food and Drug Administration (FDA) identified significant weaknesses in laboratory controls, missing analytical validation, and an inadequate stability program.

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Process of Sampling and Sample Management in the Pharmaceutical Industry

Sampling and sample management are critical interfaces between manufacturing and quality control. Only when sampling and sample management are performed systematically, representatively, and in accordance with GMP and regulatory requirements can analytical results be considered reliable and acceptable to competent authorities.

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EMA: Reflection Paper on Non-Mutagenic Impurities published

The 'Reflection paper on the qualification of non-mutagenic impurities' was published on the EMA website at the beginning of February 2026. It is intended to supplement the existing guidelines for non-mutagenic impurities (NMI) with regard to qualification and safety assessments.

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Your Input is Requested: AQCG Survey on OOS Investigations

How does your organization handle Out-of-Specification (OOS) results in practice? The ECA Analytical Quality Control Group (AQCG) invites you to share your experience and contribute to the ongoing update of AQCG OOS guidance. We would be pleased if you would participate in a short survey, which takes only a few minutes to complete.

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EMA: Q&A 'Co-Processed Excipients' published

In January 2026, the Q&A document 'Questions and Answers regarding co-processed excipients used in solid oral dosage forms (H & V)' was finally published on the EMA website.

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ECA Survey Results II: How is Statistical Process Control used in the Pharmaceutical Industry?

Phase 3 (ongoing/continued process verification) is the longest phase in the validation life cycle. Many companies use statistical process control (SPC) for this purpose. Concept Heidelberg conducted a survey for the ECA specifically on this topic. Among other things, the ECA wanted to know which control charts are used and what the limits are for cpk-values, etc. Read part II of the survey results summary. 

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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.

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