US Pharmacopeia Achieves ISO Accreditation For Certified Reference Materials

Main Category: Public Health
Article Date: 13 Aug 2008 - 3:00 PDT

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The U.S. Pharmacopeial (USP) Convention has announced that it has achieved accreditation from ACLASS to the International Organization for Standardization (ISO) Guide 34 for reference material producers (RMP) as an internationally accredited producer of Certified Reference Materials (CRM). The CRM designation represents additional rigor in the methods used to create, analyze and assign values to reference materials, many of which are well-characterized chemicals that form official USP standards. USP is the only pharmacopeia to have achieved this ISO designation. Building on its prior ISO 9000 certification and 17025 accreditation, the designation represents USP's continuing commitment to the highest standards of quality.

According to William Koch, Ph.D., USP's chief metrology officer, "This accreditation is a real landmark not only for USP but for public health as well. Measurement technology has made significant strides in the past decades. By adhering to the more stringent criteria required to become an authorized producer of CRM, USP is staying at the forefront of advances to assure the quality, strength and purity of medicines and food ingredients. Those who rely on USP standards worldwide will welcome this additional measure."

USP is developing criteria to identify which of its reference standards are candidates to become CRM, based on such properties as stability, homogeneity, customer need and others. Over time, in collaboration with stakeholders including manufacturers, regulatory bodies, other pharmacopeias and research scientists, USP will build its CRM library. This will provide manufacturers with greater accuracy and decreased uncertainty about how their products compare to the USP standards with which they must comply. With the ACLASS accreditation, USP intends to release its first CRM in the near future.

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USP - Advancing Public Health Since 1820

The United States Pharmacopeia (USP) is a private, non-profit, standards-setting organization that advances public health by helping to ensure the quality and consistency of medicines, food ingredients, and dietary supplements, promoting the safe and proper use of medications, and verifying ingredients in drugs and dietary supplements. Its standards, which are recognized worldwide, are developed by a unique process of public involvement through the contributions of volunteers representing pharmacy, medicine, and other health care professions, as well as science, academia, government, the pharmaceutical and food industries, and consumer organizations. For more information about USP and its public health programs, visit http://www.usp.org/newscenter.

Source:
Sandra Kim
US Pharmacopeia

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