Commission Implementing Regulation (EU) 2025/2154 Article 72

Cell bank maintenance and record keeping

Article 72

1. Access to cell banks shall be limited to authorised personnel. 2. Cell banks shall be maintained under storage conditions designed to maintain cell viability and prevent contamination. The international guideline ICH Q5A Guideline shall be taken into account. 3. Records of the use of the vials from the cell banks and storage conditions shall be maintained. 4. Where appropriate, cell banks shall be periodically monitored to determine suitability for use.

Read the full instrument → · Read this in context: CHAPTER XVIII — SPECIFIC REQUIREMENTS FOR ACTIVE SUBSTANCES MANUFACTURED BY CELL CULTURE OR FERMENTATION →

Other provisions in CHAPTER XVIII — SPECIFIC REQUIREMENTS FOR ACTIVE SUBSTANCES MANUFACTURED BY CELL CULTURE OR FERMENTATION

Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗ · Data as of 2026-07-04

CitationArticle 72 of Commission Implementing Regulation (EU) 2025/2154 (LawPlayer, data as of 2026-07-04)

What to look at next

Commission Implementing Regulation (EU) 2025/2154, full textChapter navigation and full text, so you can read this section in contextEuropean Union legislation EU Legal Acts by type and yearGrouped by instrument type and year of enactment, so you can find others of the same kindBrowse by type and year CHAPTER XVIII — SPECIFIC REQUIREMENTS FOR ACTIVE SUBSTANCES MANUFACTURED BY CELL CULTURE OR FERMENTATION — read this in contextThe surrounding text of the act in order, so you can see what comes before and afterChapters and sections