Billerica, MA - Do your current sampling and calibration methods and procedures meet global compliance regulations? In its Pharmaceutical Water Compliance guide, METTLER TOLEDO Thornton explain the requirements of USP <645> Water Conductivity and USP <643> Total Organic Carbon. Purified water, highly purified water, water for injection, and pure steam are used directly for pharmaceutical manufacturing processes and indirectly for system and equipment cleaning. Test sampling and calibration methods and procedures are critical to the monitoring and control of water quality, as well as meeting global compliance regulations.
In this free guide, we review the upcoming requirements of USP <645>, USP <643>, and the acceptable calibration methods and procedures that support the advantages of on-line testing.
Topics covered include:
- USP <645>Conductivity
- USP <643>Total Organic Carbon
- New requirements for 2014 including: temperature and USP <1644>, which expands on USP <645> and the operation, calibration, and maintenance of conductivity measurement systems;
- Validation of final rinse for clean in place (CIP)
- Compliance with FDA 21 CFR Part 11 and EC GMP Annex 11 and the use of electronic records in lieu of paper records
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