Practical Application of Setting up an Annual Contamination Control Strategy (CCS) Assessment

Abstract

A Contamination Control Strategy (CCS) is a strategy that focuses on how to prevent contaminations with microorganisms, particles, and pyrogens and manages risks to medicinal product quality and patient safety within a Good Manufacturing Practices (GMP) facility. A CCS should reflect on all proactive and retrospective data within a sterile and/or aseptic and/or non-sterile manufacturing environment to identify all sources of contamination and associated hazards and/or control measures. It should outline associated Quality Risk Assessments (QRAs) and Critical Control Points (CCPs) and suggest necessary control measures. An effective way to perform QRA for CCS is by adopting the Hazard Analysis Critical Control Point (HACCP) methodology, a proactive risk assessment tool. This tool can be ideally used to monitor all CCPs associated with various sources of contamination. To keep the CCS effective, it is highly recommended to have the CCS reviewed by a multidisciplinary team and updated periodically and to re-review it as necessary in the event particular issues arise. An annual review of the CCS effectiveness can be performed by constructing an assessment tool in the form of a report. The report provides an overview of all proactive and retrospective Quality Management System (QMS)-related data that may have an impact on the CCS. This report then acts as a tool to drive continual improvement of the manufacturing and control methods, as required per EudraLex Volume 4 GMP guidelines Annex 1. This article describes a practical application of setting up an annual CCS assessment within a pharmaceutical manufacturing company to keep the CCS effective. This assessment will facilitate the process of reviewing the effectiveness of all control measures over time and facilitates escalation of issues that are not under control.