Analytical Quality Control News

FDA Warning Letter Highlights OOS Handling and Stability Failures

In late September 2025, the FDA published a new Warning Letter describing significant deficiencies at an OTC drug manufacturer. Inspectors identified critical issues related to data integrity, OOS investigations, stability testing, process validation, and quality oversight.

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Pharmeuropa: Revision of Residual Solvents Chapter 2.4.24 Published for Comments

The European Pharmacopoeia has published a fully revised draft of Chapter 2.4.24. Identification and control of residual solvents in Pharmeuropa 37.4 for public consultation.

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USP: Harmonized Chapter <701> Disintegration Adopted

The United States Pharmacopeia (USP) has announced the adoption of the revised harmonized chapter <701> Disintegration, approved by the Pharmacopeial Discussion Group (PDG).

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What is the ATP?

The Analytical Target Profile (ATP) has become a central element in the development and lifecycle management of analytical procedures. But how is the ATP defined in current regulatory guidance, such as ICH Q14 and USP <1220>?

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What is the Difference between Bracketing and Matrixing?

In the context of stability studies, bracketing and matrixing strategies allow for a reduction in testing effort without significantly compromising the integrity of the results – provided they are scientifically justified and documented in accordance with regulatory requirements.

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USP-NF Stimuli Article on Apex Vessels used in Dissolution Testing: Corrected Version Published

In the Pharmacopeial Forum, PF 51(5), a corrected version of the Stimuli article entitled "Characterization of Apex Vessel Geometries and Irregularities", originally published in PF 51(1), was made available.

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Analytical Quality Group Developments May through August 2025

Find out what the ECA Analytical Quality Control Group was working on and accomplished from May to August 2025 - in the latest report.

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Meet the AQCG Board Members at PharmaLab 2025

PharmaLab 2025 continues to expand its range of current topics for Europe and beyond. Accordingly, several new tracks will be added this year, particularly in the field of analytics. The ECA Analytical Quality Control Group (AQCG) will organise a dedicated one-day conference track.

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Who is allowed to perform Sampling?

Sampling of raw materials, intermediates and finished products is a critical quality-related activity that directly affects product quality, patient safety and GMP compliance. This raises a frequently discussed question in our GMP training courses: Who is actually permitted to perform sampling – and in particular, is production personnel allowed to do so?

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WHO Guidelines on Reducing Animal Testing

WHO: With the publication of new guidelines, another relevant organisation is now emphasising the importance of the 3R principle in the quality control and quality assurance of biopharmaceutical products. This means that efforts in Europe and, for some time now, in the USA are now also moving in the same direction globally.

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