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The guideline 'Additional guidance on the assessment on the risk assessment for presence of N-nitrosamines in APIs', first published in February 2020, has now been revised by a subgroup of the 'APIC Nitrosamines Task Force' and recently published in its latest version on the APIC website. The document is now called 'Nitrosamine Risk Management: Guidance for API Manufacturers' and has been extensively updated.

The FDA found serious GMP deficiencies during an inspection of a Chinese pharmaceutical manufacturer in November 2024. These include, above all, inadequate hygiene and ensuring the sterility of the products. For example, medicinal products were labelled as 'sterile' although neither sterilisation nor sterility tests were carried out.

In November 2024, the US FDA inspected a French sterile manufacturer of prescription and OTC medicines. The inspectors found significant GMP violations. Deficiencies were cited in the handling of complaints, the microbiological control of aseptic processes and the cleaning and maintenance of production equipment.

In a recent Warning Letter, the FDA outlines severe GMP deficiencies in the manufacture of OTC hand sanitizers and antibacterial soaps, including missing identity testing, lack of stability data, and absent process validation. Critical raw materials such as glycerin and ethanol were accepted without proper testing – despite their known risk of contamination with diethylene glycol (DEG), ethylene glycol (EG), or methanol, substances that have caused fatal poisoning incidents worldwide.