Optimizing Cleaning Validation Practices

Rubrik: GxP

(Treffer aus pharmind, Nr. 09, Seite 798 (2025))

Angelikaki F

Optimizing Cleaning Validation Practices / In Complex Contract Development Manufacturing Environments · Angelikaki F · Compass by Famar
Cleaning Validation Life cycle Contamination risk Efficiency The scope of cleaning validation (CV), as outlined by global regulatory authorities, encompasses the documented evidence that cleaning procedures consistently and effectively remove chemical, microbiological, and particulate contaminants to predefined and acceptable levels. Regulatory bodies such as the FDA and EMA emphasize that cleaning validation must demonstrate the removal of residues from active pharmaceutical ingredients (APIs), excipients, and cleaning agents (e.g. detergents), ensuring that no carryover poses a risk to product quality or patient safety [ 1 , 2 ]. Additionally, it must address the control of microbiological contamination, including microbial bioburden, endotoxins, and ...