MONITORING ORGANICS PHARMACEUTICALS STANDARDS TOC USP MEASUREMENTS

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Abstract

Monitoring the quality of water used to manufacture pharmaceutical products is critical to their quality. Traditionally, manufacturers have used laboratory equipment for monitoring. Because laboratory testing is separate from the water system, ongoing process improvement is difficult. Pharmaceutical quality systems are moving to monitoring water on-line within the water system because the industry and regulators are realizing the inherent quality improvements and cost advantages of continuous in-process measurements. Achieving the advantages of real-time testing and release of pharmaceutical water is not without challenges. Implementations must negotiate a complex regulatory environment. Regulators must be convinced that pharmaceutical companies understand their new processes and have the knowledge and data to control them. A quality systems approach simplifies the implementation, reduces risks associated with change, and quickly achieves cost advantages.

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