White Paper: Environmental monitoring data

ABSTRACT

An environmental monitoring (EM) program is required to document, that the manufacturing environment of a product is compliant, with its specifications and performs in an adequate state of control. Due to technical limitations of the conventional culture method and scientific concerns, the microbiological monitoring is not able to prove quantitative information about the sterility assurance of a product. Even an extensive microbiological sampling plan cannot prove the absence of contamination. As a consequence, there is a current shift in the thinking about the microbiological EM, leading away from an approach based on compliance with arbitrary numerical levels to a quality-by-design, risk-based approach. Until now, only United States Pharmacopeia chapter <1116> "Microbiological Control and Monitoring of Aseptic Processing Environments" reflects the evolution of guidance documents towards this new direction. Meanwhile, pharmaceutical manufacturers are still concerned about the best way to take full advantage of the huge amount of data generated by their microbiological EM. While inescapable answer at this complex question is well beyond the topic of this whitepaper, some qualitative approaches reflecting current trends towards a parametric product release will be addressed.Pharmaceutical companies want to produce safe & effective high quality products within a set budget.In this aim, the Environmental monitoring (EM) program is mainly proactively used as a quality assurance tool. It validates the sanitization program and helps in determining how often cleaning & sanitization is required.

1    INTRODUCTION

Pharmaceutical companies want to produce safe and effective, high quality products within a set budget. In this aim, the EM program is mainly proactively used as a quality assurance tool. It validates the sanitization program and helps in determining how often cleaning and sanitization is required. It proceeds by measuring the overall effectiveness of sanitary processes, personnel practices, and operational methods used when a given batch is being manufactured. If the EM is used correctly it can act as an early warning system, by quickly detecting trends and drifts in the manufacturing environment. Globally, the EM program gives relevant information to document that all manufacturing steps were realized in an environment in a coherent, validated state of control. And that is exactly what regulatory authorities want.
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