Analytical Quality Control News

FDA Warning Letter: From Inadequate Investigations and Laboratory Controls to Supplier Qualification and Process Validation.

The U.S. Food and Drug Administration (FDA) issued a Warning Letter to a drug manufacturing facility in California. Inspectors identified inadequate investigations and CAPA management, missing identity testing for high-risk raw materials, and unvalidated manufacturing processes. The FDA also noted serious deficiencies in laboratory controls and overall quality oversight.

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Shelf Life vs. Retest Date - What's the Difference?

Both shelf life and the retest date are based on stability data, but they have different applications and implications, especially for the drug substance versus the drug product. So what exactly is the difference, and which regulatory requirements are most relevant?

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Mean Kinetic Temperature (MKT): Calculation, Benefits, and Limitations

The mean kinetic temperature (MKT) is a calculated value that describes the cumulative thermal load of a medicinal product over a certain period of time. In the context of storage and transport, it can be used to assess temperature deviations – however, its use is not always appropriate or permitted by regulations.

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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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