USP Acceptable TOC Levels For Pharmaceutical Water: How To Achieve Them?

Meeting the regulations and validation rules is an important task for the pharmaceutical industry. In order to be compliant with the regulations and meet the required quality and safety standards, the Pharmaceutical industry must develop economical and competitive production and cleaning methods, which in turn will help the industry develop appropriate operational methods.

Compliance with the regulations must be maintained within the pharmaceutical industry throughout the different processes. The processes can be grouped under three general categories: Preparation (includes processing and innovation), Production, and Waste Discharge.

Throughout such processes, requirements include using pharmaceutical quality water, monitoring the pharmaceutical water used, and achieving the required cleaning level to avoid any cross contamination. During the process of monitoring the pharmaceutical water and maintaining the required quality and safety to meet the regulations, the FDA does not recommend any one specific analytical technique to be used for the analysis. The FDA states that any "Specific" or "Non-Specific" analytical technique can be used, as long as the technique provides results that prove its ability to detect any contaminants that would affect the quality of the water used.