Drug Security: Brazil Gets Its Own US Pharmacopeia Branch

    Drug manufacturing

    Drug manufacturing The standards-setting authority for all prescription and over-the-counter medicines made or sold in the United States, the U.S. Pharmacopeia (USP) Convention has just opened its newest international site located in São Paulo, in southeastern Brazil.

    Located at the WTorre Technology Park, the USP-Brazil facility supports USP's international public health mission to improve the health of people around the world through public standards and related programs that help ensure the quality and safety of medicines and foods. USP's standards and information are recognized in more than 130 countries worldwide.

    These standards have helped to ensure public health around the world for close to 200 years. USP is a non-governmental, not-for-profit public health organization. 

    To commemorate the opening of the site, a delegation of USP volunteers and executives, including Dr. René Bravo, president, USP Convention; Dr. Duane Kirking, at-large trustee, USP Board of Trustees; Dr. Roger L. Williams, executive vice president and CEO; Dr. Darrell Abernethy, chief science officer; Dr. William Koch, chief metrology officer; John Fowler, chief global services officer; and Dr. Flavio Vormittag, vice president, international-Brazil, joined officials from the National Health Surveillance Agency (ANVISA); the Brazilian Pharmacopeia Committee (CFB); the Health Quality Control National Institute (INCQS); the Brazilian Association of Research-based Pharmaceutical Manufacturers Association (Interfarma); the Brazilian Federation of the Pharmaceutical Industry (Febrafarma); and many others for a ribbon-cutting ceremony at the new facility.

    "This new site demonstrates USP's commitment to ensuring the quality and safety of pharmaceuticals, dietary supplements and food ingredients for everyone, regardless of geographic, economic or political borders," said Dr. Williams. "As the world continues to focus on these issues, it is even more important for standards-setting bodies and governments to collaborate. This office and laboratory facility will help USP work with Brazilian regulators and manufacturers to move toward that goal."

    "USP-Brazil will work closely with ANVISA, the Brazilian Pharmacopeia, Febrafarma and other organizations to help ensure the quality of medicines and food ingredients and better serve our customers," said Dr. Vormittag. "Our presence will benefit Brazilian manufacturers, government agencies and ultimately patients in Brazil, the U.S., and the many countries to which Brazil exports."

    The USP-Brazil facility will provide local manufacturers with better access to USP's publications and reference standards as well as other related services. USP's reference standards are used to help assure quality through testing to assess whether an article conforms to the published standards in the United States Pharmacopeia and National Formulary (USP-NF) or the Food Chemicals Codex (FCC).

    The new facility, which is approximately 1,800 square meters, has both state-of-the-art office and laboratory space, and is ideally located near many of USP's key pharmaceutical clients. Dr. Vormittag oversees the facility and in the process of hiring staff to begin operations.

    USP-Brazil will further expand USP's capacity to reach those countries around the world that rely upon USP standards. With headquarters in Rockville, Maryland in the United States, USP also operates facilities in Hyderabad, India; Shanghai, China; and Basel, Switzerland.

    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.

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