Analytical Quality Control News

At the end of July 2025, the report 'Nitrosamine impurities in human medicines - The response of the European Medicines Regulatory Network' was published on the EMA website.

The U.S. Food and Drug Administration (FDA) has issued a Warning Letter to an Indian contract testing laboratory. Investigations of out-of-specification (OOS) results lacked adequate scientific rationale, and new test results were used to invalidate prior OOS findings without sufficient justification. Furthermore, FDA investigators discovered torn and discarded original CGMP documents in the facility's waste disposal area, and electronic data had been improperly altered or deleted.

On 25 July 2025, the European Medicines Agency (EMA) published an overview of the comments received on the draft version of the new "ICH Guideline M13B on bioequivalence for immediate release solid oral dosage forms - additional strengths - Step 2b".

In April 2025, the WHO published the new guideline ‘TRS 1060 - Annex 2: WHO good practice considerations for the prevention and control of nitrosamines in pharmaceutical products’ on its website, which must be taken into account by manufacturers and packagers of excipients, active ingredients, processing aids and finished medicinal products. It should be noted that WHO Annex 2 is to be regarded as a supplement to the existing GMP guidelines and their requirements with regard to nitrosamines, as set out, for example, in ICH M7 (R2).