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Demonstrating ongoing commitment to quality in all its efforts, the U.S. Pharmacopeial Convention (USP) has been recommended for global re-certification of its quality management system in accordance with ISO 9001:2008 based on a successful audit by the BSI Group. The ISO 9001:2008 re-certification demonstrates that USP's quality management system complies with the ISO standard and provides effective management of internal processes to meet international quality requirements. All USP’s global sites are included in the current re-certification: India, China, Brazil and Switzerland as well as headquarters in Maryland.
USP’s ISO 9001:2008 accrediting body is the independent registrar, the BSI Group. Additionally, USP’s ISO 17025:2005 accrediting body is ACLASS, one of three ANSI-ASQ National Accreditation Boards.
USP is a nonprofit, scientific organization that develops public standards to help ensure the identity, strength, quality and purity of pharmaceuticals, food ingredients and dietary supplements. USP’s standards for medicines are enforceable in the United States by the Food and Drug Administration, and USP’s quality standards are used in more than 140 countries.
“People around the world count on USP standards to help ensure the quality of medicines, food ingredients and dietary supplements,” said Roger L. Williams, M.D., USP’s chief executive officer. “Because of this trust and obligation, we must adhere to the most rigorous standards of quality in all our work. This global ISO re-certification is a clear affirmation of our commitment. I am very proud of USP’s staff around the world for ensuring that our internal processes reflect our long-standing dedication to upholding quality.”
To achieve this global re-certification, BSI Group auditors looked at USP’s quality management system as well as information security plans, implementation of tools for improved reporting in quality assurance, accounting and finance, organizational operation manuals and standard operating procedures among other measures. Following thorough assessment at all USP sites, BSI Group recommended re-certification.