Analytical Quality Control News

FDA issues Warning Letter due to GMP Violations at Chinese Drug Manufacturer

The United States Food and Drug Administration has issued a Warning Letter to a Chinese manufacturer. The violations include inadequate raw material testing and insufficient stability testing programs.

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CMDh/EMA: Appendix 1 for Nitrosamines Revised

Appendix 1 to the nitrosamine Q&A document "Questions and answers for marketing authorization holders/applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 referral on nitrosamine impurities in human medicinal products" of the EMA/CMDh was updated in February 2025.

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USP-NF Stimuli Article on Analysis of Residual Solvents

In the Pharmacopeial Forum, 51(2), a Stimuli Article entitled "Direct Analysis of Class 2 Residual Solvents Using Molecular Rotational Resonance Spectroscopy" has been published. The study focuses on the development and validation of a continuous headspace-MRR method for analyzing selected Class 2 residual solvents.

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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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