NSF International, a global independent public health organization with 66 years of experience, including 25 years of pharmaceutical expertise through its NSF Health Sciences Division, is launching NSF Reference Standards™, which will produce reference standards that are traceable to official U.S. and European pharmacopeial standards. Pharmaceutical manufacturers worldwide use reference standards as comparative standards to demonstrate the identity, purity, quality and strength of their pharmaceutical products and ingredients.
Completely traceable to both US and European pharmacopeial standards, NSF Reference Standards are:
- Tested independently by a minimum of three collaborating laboratories
- Traceable to both United States Pharmacopeia® (USP) and European Pharmacopeia (EP) reference standards
- Verified to conform to U.S. Food and Drug Administration (FDA) and European Directorate for the Quality of Medicines & HealthCare (EDQM) regulatory requirements
- Produced and tested following the principles of current Good Manufacturing Practices (cGMPs)
- Accompanied by documentation that includes a Certificate of Analysis and Material Safety Data Sheet
Traceability of NSF Reference Standards to official pharmacopeial standards is established through rigorous collaborative laboratory testing against official standards in accordance with the principles of cGMPs. Each NSF Reference Standard is tested to meet the compendial requirements of the individual pharmacopeial monographs and includes a detailed documentation package with a Certificate of Analysis and Material Safety Data Sheet.
“NSF Reference Standards will set the bar for the quality and purity of pharmaceutical products while also offering companies favorable pricing,” said Lori Bestervelt, Ph.D., NSF Chief Technical Officer and Senior Vice President over the NSF Health Sciences Division.
“Developing the NSF Reference Standards program is a natural step for NSF’s Health Science Division, which has over 25 years of pharmaceutical industry experience gained through NSF-DBA, NSF Pharmalytica, and through the team of experts leading the NSF Reference Standards program, each of whom has significant expertise in reference standards manufacturing, including quality and regulatory requirements. This is in addition to NSF’s 66-year history developing public health standards and providing testing and inspection services to the food, water, dietary supplement and consumer products industry.”
The NSF Reference Standards program is led by industry experts with 20-35 years of pharmaceutical experience, including extensive expertise in reference standard manufacturing, quality assurance and testing:
- Steven Lane, General Manager, has more than 22 years experience in FDA- and DEA (Drug Enforcement Administration)-regulated industries, including expertise managing reference standards operations.
- Tom Savage, Director of Scientific and Regulatory Compliance, has more than 35 years of experience with the U.S. FDA, including expertise in testing reference standards candidates in FDA laboratories.
- Linda Carlisle, Technical Program Manager, has more than 20 years of industry experience, with expertise in the technical aspects of reference standards production, quality assurance and testing.
- Chris Aiyer, Senior Business Development Manager, has more than 20 years of technical sales experience working with the global pharmaceutical and biotechnology industries, understanding and serving customer requirements.
NSF Reference Standards for many commonly tested products have already been released and are available for immediate purchase on NSF’s dedicated website at nsf-rs.org. The NSF Reference Standards program will continue to add new titles to this portfolio throughout the remainder of 2011 and 2012, with an ultimate offering of over 300 items. Check the website on a regular basis for updated offerings.
NSF Reference Standards may be purchased online at nsf-rs.org. An electronic PDF of the catalog also is available on that site.
In addition to NSF Reference Standards, the NSF Health Sciences Division includes NSF Pharmalytica, a GLP & GMP contract laboratory that offers analytical testing, consulting, training, registration and R&D services; NSF-DBA, which offers training, auditing and consulting to the pharmaceutical, medical devices and dietary supplements industry; and the NSF Dietary Supplement program, which offers dietary supplement testing and certification, banned substances screening and certification, and GMP audits.
About NSF International: NSF International, an independent, not-for-profit organization, certifies products and writes standards for food, water, dietary supplements and consumer goods to protect human health and the environment (nsf.org). Founded in 1944, NSF is committed to protecting public health and safety worldwide. NSF operates in more than 120 countries and is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment. NSF services include pharmaceutical, medical device and dietary supplement services through NSF Health Sciences; food safety audits, global food safety certification, foodservice equipment and bottled water certification through NSF Food Safety and Quality; drinking water products certification through NSF Water Systems; consumer product and toy testing; sustainability services through NSF Sustainability; management systems registrations through NSF International Strategic Registrations (NSF-ISR); and NSF Education and Training courses.
The NSF Health Sciences Division offers reference standards, certification, training, consulting, GMP and GLP testing, R&D and auditing for the pharmaceutical, dietary supplement and medical device industries. It includes NSF Reference Standards, NSF Dietary Supplement Certification, NSF Pharmalytica and NSF-DBA, and operates globally throughout North America, Europe, Middle East, Africa, Asia and Latin America. Additionally, NSF led the development of the official American National Standard for Dietary Supplements, NSF/ANSI 173.