METTLER TOLEDO Thornton has produced a guide for the pharmaceutical industry on compliance with global pharmacopeias for pharma waters. The complimentary guide covers existing regulations and new requirements for 2014.
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
About Mettler Toledo:
METTLER TOLEDO specializes in the area of precision instruments for professional use. METTLER TOLEDO laboratory instruments are used in research, scientific, drug discovery, and quality control labs, amongst many others in the pharmaceutical, chemical, food and cosmetics industries. METTLER TOLEDO comprehensive industrial solutions cover the various steps in a host of manufacturing processes at many of the same customers that laboratory serves. Solutions range from receiving raw materials through various manufacturing processes, in-line process control and end-of-line packaging control, to logistics and shipping. Increasingly, these solutions are fully integrated into the customer's IT environment, helping automate their workflows. In food retail, our offering for fresh food management ranges from receiving and pre-packaging, to in-store solutions for self-service departments, deli counters, and checkout terminals.
Mettler-Toledo International Inc.
Im Langacher, Zip Code 8606
E-Mail : [email protected]
Phone : +41-44-944 33 85
Website : www.mt.com
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The Complimentary Guide to Water Compliance for Global Pharmacopeia Requirements is available to download now. Please visit us.mt.com/us/en/home/supportive_content/specific_overviews/product-organizations/pro/Pharma-Water-Compliance.html?crel=ePR_PP_EN
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