Setup of a Contamination Control Strategy Using the Hazard Analysis Critical Control Point (HACCP) Methodology.

Abstract

A Contamination Control Strategy (CCS) is a document that focuses on how to prevent contaminations with microorganisms, particles, and pyrogens within sterile and/or aseptic and preferably also in nonsterile manufacturing facilities. This document determines to what extent measures and controls in place are efficient in preventing contamination. In order to efficiently evaluate and control all potential hazards associated with sources of contamination within a CCS, the Hazard Analysis Critical Control Point (HACCP) methodology could be a useful tool to monitor all Critical Control Points (CCPs) related to various sources of contamination. This article describes a way to set up the CCS within a pharmaceutical sterile and aseptic manufacturing facility (GE HealthCare Pharmaceutical Diagnostics) by applying the HACCP methodology. In 2021, a global CCS procedure and a general HACCP template became effective for the GE HealthCare Pharmaceutical Diagnostics sites having sterile and/or aseptic manufacturing processes. This procedure guides the sites through the setup of the CCS by applying the HACCP methodology and helps each site to evaluate whether the CCS is still effective taking all (proactive and retrospective) data following the CCS into account. A summary of setting up a CCS using the HACCP methodology, specifically for the pharmaceutical company GE HealthCare Pharmaceutical Diagnostics Eindhoven site, is provided in this article. Use of the HACCP methodology enables a company to include proactive data within the CCS, making use of all identified sources of contamination, associated hazards, and/or control measures and CCPs. The constructed CCS allows the manufacturer to identify whether all included sources of contamination are under control and, if not, which mitigatory actions need to be performed. All current states are reflected by a traffic light color to reflect the level of residual risk, thereby providing a simple and clear visual representation of the current contamination control and microbial state of the manufacturing site.