Bio-Rad Partners with the U.S. Pharmacopeial Convention
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Bio-Rad Laboratories, Inc. has announced the release of beta version of USP Spectral Library™ powered by Bio Rad's KnowItAll® software technology platform for spectral analysis, identification, search, data management, and reporting.
The USP Spectral Library Project is a new interactive, authoritative, and comprehensive collection of spectral information on food and drug quality. Manufacturers can use the USP Spectral Library on the KnowItAll platform for raw material identification during routine quality control measures to confirm the identity of active pharmaceutical ingredients (APIs) and excipients used in their products.
With applications in quality standards development, rapid screening in the field for counterfeit and substandard foods and medicines based on portable analytical technology, and the identification of raw materials as well as finished products, the USP Spectral Library can be a useful tool for regulatory authorities, law enforcement agencies, hospitals, pharmacies, manufacturers, and distributors around the world.
To ensure the highest quality, USP generates spectra for the USP Spectral Library using the collaborative testing model for which USP is renowned. The resulting spectral databases are made available in the KnowItAll platform in a new, Bio-Rad self-validating 21 CFR Part 11-compliant quality control application called QC Expert™.
"The USP Spectral Library has the potential to help ensure the quality of medicines and foods throughout the world," said Ed Zhao, USP's Vice President of Business Development and Allied Compendial Programs.
"Bio-Rad is honored to partner with USP on such an important project for quality control within the pharmaceutical and food industries," said Gregory M. Banik, Ph.D., General Manager, Bio-Rad Informatics.
Banik continued, "We are delighted that Bio-Rad's KnowItAll technology platform was such a perfect fit to bring USP's innovative vision for the USP Spectral Library to commercial reality."
