CONTAMINATION CONTROL
Generation of a Contamination Control Strategy
PROJECT OVERVIEW
A small-scale parenteral nutritional compounding facility in Europe engaged CAI to support remediation efforts required by its local Regulatory Authority. The client site had been operational for several years, with experienced management staff. However, a comprehensive contamination control document, outlining all critical control points and assessing the effectiveness of control and monitoring measures, had yet to be established.
CAI, leveraging its access to various suitable templates, collaborated with the client to select a document
format suitable to their company needs. Where gaps were identified, corrective and preventive actions (CAPA) were documented.
CAI brought deep expertise in Quality Compliance and Regulatory Affairs, combined with a strong collaborative relationship with the client, enabled the successful authoring, review and approval of the CCS document, delivered on time and within budget. The document was submitted to the regulatory authority which was accepted without further comment.