Analytical Quality Control News

EMA publishes Considerations regarding the Implementation of ICH M13A on Bioequivalence

The European Medicines Agency (EMA) has published a new document entitled "Considerations regarding the implementation of ICH M13A on bioequivalence for immediate-release solid oral dosage forms".

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Further Modifications to USP Chapter <621> Chromatography Published for Comment

In the Pharmacopeial Forum, PF 51(2), a new version of USP General Chapter <621> Chromatography has been published. The System Sensitivity and Peak Symmetry subsections were further modified to clarify the applications of these new requirements. Comments can be submitted until 31 May 2025.

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WHO: Updates on Method Transfer

In 2022, the WHO published the "Technical Report Series 1044, 2022" called "TRS 1044 - Annex 4: WHO guidelines on technology transfer in pharmaceutical manufacturing" on the subject of technology transfer.

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Proposed Update to USP <1058> on Analytical Instrument and System Qualification

In the Pharmacopeial Forum, PF 51(2), a proposed revision of USP Chapter <1058> Analytical Instrument Qualification has been published for comments. The chapter provides general guidance in a scientific, risk-based approach for carrying out an analytical instrument and system qualification (AISQ). Comments can be submitted until 31 May 2025.

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Illegally imported Medicinal Products into Switzerland in 2024: Fewer Shipments, but increasing Risks

Swissmedic, the Swiss authorisation and supervisory authority for drugs and medical products, has provided information on illegal drug imports into Switzerland. In 2024, 5,668 illegal drug imports were seized, representing a 15% decrease in shipments compared to the previous year. However, the danger remains: Illegal products from dubious online sources often contain incorrectly declared, overdosed, or even no active substances at all, posing significant health risks.

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Eurachem publishes Leaflet on Analytical Equipment and Systems

Eurachem has recently published a leaflet titled “Fitness for the intended use of analytical equipment and systems”. The document outlines the role and handling of analytical equipment and systems in the process of a laboratory dealing with the analysis of chemical elements and molecules. It was prepared by the Eurachem Analytical Equipment and Systems Qualification Working Group, which is chaired by Dr. Ernst P. Halder.

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EMA Q&A - When is Testing for Endotoxin Masking Effects necessary for biological Products?

The EMA has recently published an update to its question and answer catalog for biological medicinal products. Among other things, it also addresses the question of when endotoxin masking effects must be taken into account for biological products.

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FDA Warning Letter Highlights Responsibilities of Contract Testing Laboratories

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an American contract testing laboratory, emphasizing that it considers contractors as extensions of the manufacturer’s own facility. The authority identified critical deficiencies, including the failure to validate microbiological testing methods in accordance with USP standards and inadequate investigation of temperature and humidity deviations in laboratory equipment.

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New ISO/TR 33402:2025 on Reference Material Preparation

The International Organization for Standardization (ISO) has published ISO/TR 33402:2025 "Good practice in reference material preparation". This new technical report replaces ISO Guide 80:2014 and expands its scope to cover all types of matrix reference materials, not just those used for statistical quality control.

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FDA Warning Letter: Chinese API Manufacturer on Import Alert Due to CGMP Violations

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter highlighting significant deviations from Current Good Manufacturing Practice (CGMP) for Active Pharmaceutical Ingredients (APIs). A facility in China was found to have multiple compliance deficiencies based on a review of records submitted in response to an FDA request.

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