Beckman Coulter Life Sciences -Enhancing Root-Cause Investigations in Pharmaceutical Water System Contamination Using TOC Analyzers. - Express Pharma

Express Pharma

Factuality

Ownership

Beckman Coulter Life Sciences -Enhancing Root-Cause Investigations in Pharmaceutical Water System Contamination Using TOC Analyzers. - Express Pharma

The FDA’s 21CFR guidance highlights the importance of corrective and preventative action (CAPA) in addressing deviations that could affect product quality. Regulatory authorities expect thorough investigations, corrective measures, and ongoing assessment to prevent recurrence of these deviations. TOC or conductivity contamination events can be transient in nature. For example, a water system that is experiencing gradual biofilm build up may expe…