EU GMP Chapter 5, Production, new Q&A

Date

July 16, 2026

Category

EU Regulations

Description

On 13 July 2026, the EMA published a new Q&A interpreting Chapter 5 GMP requirements entitled "What are technical and organisational measures that should be taken into consideration to prevent microbial contamination of non-sterile medicinal products?", see www.ema.europa.eu/en/documents/other/what-are-technical-organisational-measures-should-be-taken-consideration-prevent-microbial-contamination-non-sterile-medicinal-products_en.pdf

This requires that to prevent microbial contamination in non-sterile medicines, companies should take the following measures:

• Technical: to include facility design, validated cleaning and disinfection, supplier evaluation, and microbiological controls.
• Organisational: to involve proper gowning, personnel training, hygiene, health monitoring, and environmental controls.  Risk management guide implementation, emphasising cleaning validation, suitable water, and disinfection methods to ensure product quality and patient safety.