Generation Of A Contamination Control Strategy

An unaddressed regulatory compliance issue prompted a small-scale parenteral nutritional compounding facility in Europe to seek remediation support. The facility engaged an external partner to develop a contamination control strategy (CCS) document, a critical requirement under the revised Eudralex Volume 4, Annex 1 guideline. Through direct observation of operations and a gap assessment, a senior agent collaborated with the facility's team to identify critical control points and potential contamination sources.

The project involved updating procedures, defining remediation actions, and securing budget approval for necessary investments. Ultimately, a comprehensive CCS document was delivered on time and within budget, with the final document submitted and accepted by the regulatory authority. Learn how a collaborative, pragmatic approach can support compliance and continuous improvement.