1. Carryover of residual materials into successive batches shall not result in the carryover of degradants or microbial contamination that may adversely alter the established active substance’s impurity profile.
2. Production operations shall be conducted in a manner that prevents contamination of active substances or intermediates thereof by other materials.
3. Precautions to avoid contamination shall be taken for the handling of active substances after purification.
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 38 of Commission Implementing Regulation (EU) 2025/2154 (LawPlayer, data as of 2026-07-04)
