Thursday, November 26, 2015

NSF First to Earn ANSI Accreditation to Certify Manufacturers to Current GMP Standard

NSF and International Pharmaceuticals Excipients Council encourage manufacturers to achieve certification to demonstrate compliance to multiple regulatory and industry requirements for excipients

ANN ARBOR, Mich. and ARLINGTON, Va. – NSF Health Sciences Certification, LLC (NSF), which provides testing, auditing, certification and training for the pharmaceutical industry, has been accredited by the American National Standards Institute (ANSI) to certify excipient manufacturers to the American National Standard for pharmaceutical excipients, NSF/IPEC/ANSI 363: Good Manufacturing Practices (GMP) for Pharmaceutical Excipients.
The globalization of the pharmaceutical industry, combined with a global regulatory focus on preventing counterfeit and adulterated products, led to the need for an updated excipient quality and control standard. The new standard was published by NSF International and the International Pharmaceutical Excipients Council (IPEC). It provides a comprehensive framework that incorporates the most current regulatory and industry requirements into a single rigorous standard for the manufacturing and distribution of pharmaceutical excipients.
Excipient manufacturers that earn NSF/IPEC/ANSI 363 certification from an accredited organization such as NSF provide additional assurance of excipient quality to their pharmaceutical customers. Additionally, an accredited NSF/IPEC/ANSI 363 Certificate of Conformance from NSF may replace the need for multiple audits from suppliers, saving manufacturers cost associated with audit redundancy and production disruption.
“NSF/IPEC/ANSI 363 incorporates the most current thinking and best practices for pharmaceutical excipient manufacturing and is aligned with major regulatory guidelines such as PQG 2006, ICH Q9 and ICH Q10. Accreditation from the American National Standards Institute is a testament to the high caliber of NSF’s audit team and their ability to deliver truly independent evaluations against the most comprehensive and current excipient GMP standard available,” said Maxine Fritz, Executive Vice President of NSF Pharma Biotech Consulting, part of NSF International’s Health Sciences Division.
“Both regulators and industry benefit from the time and cost savings of a harmonized excipient GMP standard like NSF/IPEC/ANSI 363,” said John Giannone, Chairman, IPEC-Americas. “IPEC-Americas will be offering training seminars to help the industry better understand the new NSF/IPEC/ANSI 363-2014 Good Manufacturing Practices (GMP) for Pharmaceutical Excipients Standard and how it improves upon other global excipient standards.”
The NSF/IPEC/ANSI 363 standard was developed with balanced input from a committee of pharmaceutical excipient experts from regulatory, industry and academic fields. The standard references 14 regulatory guidelines and industry standards for excipients, including U.S. Food and Drug Administration regulations, International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), and International Pharmaceutical Excipients Council (IPEC-Americas) and Pharmaceutical Quality Group (PQG) guides for pharmaceutical excipients.
For more information about NSF’s Excipient Certification Program, please contact Austin Caudle at +1 734-545-3376 or excipients@nsf.org, or visit NSF International’s website. To purchase a copy of NSF/IPEC/ANSI 363, visit the NSF International bookstore.
Editor’s note: If you would like to set up an interview with an excipient quality expert, please contact NSF International Communications Manager Liz Nowland-Margolis at media@nsf.org
About NSF International: NSF International is a global independent organization that writes standards, and tests and certifies products for the health sciences, food, water and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. NSF International is a Pan American Health Organization/World Health Organization Collaborating Center on Food Safety, Water Quality and Indoor Environment. The NSF Health Sciences Division offers training and education, consulting, auditing, GMP and GLP analytical testing, certification, R&D, regulatory guidance and corporate compliance for the pharma biotech, medical device and dietary supplement industries throughout the product lifecycle. NSF Health Sciences Certification, LLC does not provide consulting services and use of any NSF International consulting service does not, in any way, make certification simpler, easier, faster or less expensive. NSF Health Sciences Certification, LLC makes its certification evaluations and decisions impartially and independent from any NSF International activity.
About IPEC – Americas: IPEC- Americas is the industry association that develops, implements, and promotes global use of appropriate quality, safety, and functionality standards for pharmaceutical excipients and excipient delivery systems. IPEC-Americas, along with our counterparts in Europe, China and Japan serves as primary international resource on excipients for its members, governments and public audiences.

NSF International and Global-Mark Partner to Certify to Australia’s WaterMark Program

WaterMark certification essential for manufacturers selling pipes and other plumbing products into the Australian and New Zealand markets

ANN ARBOR, Mich. — Global public health organization NSF International and Australian-based certification organization Global-Mark have partnered to provide WaterMark certification, which is required for all plumbing products used in Australia. The partnership combines Global-Mark’s expertise in Australian water regulations with NSF International’s experience in testing and certifying plumbing products to national and international standards.
WaterMark certification demonstrates that plumbing products comply with the quality and safety regulatory requirements of Australia and New Zealand, including the Plumbing Code of Australia. The aim of the partnership is to streamline WaterMark certification and enable plumbing manufacturers to bring their certified products to Australian and New Zealand (AS/NZ) markets.
Under the terms of the agreement, Global-Mark will serve as the program administrator, providing facility audits, reviewing audit and test reports and issuing the WaterMark certificates. NSF International will continue to provide testing of products to the AS/NZ standards and other WaterMark test criteria and will supply the test reports to Global-Mark for review.
“NSF International is committed to providing our clients with high quality certification services,” said Clif McLellan, Vice President of NSF International’s Global Water Division. “This partnership will ensure NSF clients access to the Australian and New Zealand markets with the most accurate, timely WaterMark updates through Global-Marks local expertise in the AS/NZS standards.”
“Both NSF International and Global-Mark share a commitment to ensuring the safety and quality of products that come into contact with drinking water. Combining our expertise in plumbing product testing and certification will be a great benefit to our customers,” said Herve Michoux, Managing Director at Global-Mark.
For additional information about the NSF International and Global-Mark partnership, please contact Laurent Michoux atlaurent.michoux@global-mark.com.au.
Editor’s Note: To schedule an interview with an NSF International WaterMark expert, please contact Liz Nowland-Margolis atmedia@nsf.org or +01 (734) 418-6624.
About NSF International: NSF International is a global independent organization that writes standards, and tests and certifies products for the water, food, health sciences and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide. Operating in more than 165 countries, NSF International is a Pan American Health Organization/World Health Organization Collaborating Center on Food Safety, Water Quality and Indoor Environment.
NSF’s global water services include testing, certification and auditing for municipal water treatment components and chemicals, plastic piping systems, plumbing fixtures and fittings, point-of-use and point-of-entry water systems and filters.
About Global-Mark: Global-Mark is one of the leading conformity assessment bodies (CABs) in Australia, accredited by the Joint Accreditation System of Australia and New Zealand (JAS-ANZ). The organization started trading around 10 years ago, and now supports around 4000 certificates (in management systems, program certification and sustainability). For more information, please contact Global-Mark at +61 2 9886 0222 or visit the Global-Mark website

Thursday, November 13, 2014

NSF Expands Food Safety Certification Services in UK and Ireland with Acquisition of Knight

NSF International and Knight customers benefit from integrated food quality certification services tailored to the local, regional and global markets

ANN ARBOR, Mich., USA and NORTHWICH, UK – Global public health organization NSF International has acquired Knight International Inspectorate. The acquisition strengthens NSF International’s integrated food safety and quality auditing and certification services in the UK and Ireland while providing customers in the region access to an enhanced range of auditing and certification services.
Knight International Inspectorate is a UKAS (United Kingdom Accreditation Service)-accredited certification company specializing in a variety of food safety certifications. They include, GFSI (Global Food Safety Initiative) and ISO quality management systems certification and specific industry schemes such as RSPO (Round Table Sustainable Palm Oil), FSSC 22000 (Food & Packaging) and PS 9000 (Pharmaceutical Standard).
The organization will be known as NSF Knight and the staff and location will remain in Northwich under the leadership of Phillip Knight as Managing Director of NSF Knight.
NSF Knight customers will continue to benefit from highly integrated food safety and quality certification services including GFSI-benchmarked standards bundled with ISO 9000 (quality management systems), ISO 14000 (environmental management systems), OHSAS 18001 (occupational health and safety) and ISO 50001 (energy management systems). Bundling these programs provides cost and time savings to companies operating in the UK and Ireland as well as multinational organizations with operations in this region.
“Because of NSF International’s 70 years of excellence in food safety and quality our customers in the UK and Ireland now have access to a greater range of auditing and certification services on a global scale,” said Phillip Knight, Managing Director of NSF Knight.
Additionally, Knight customers will gain access to a broad array of food safety testing, auditing, certification and training services as well as specialist knowledge in areas like agriculture, horticulture and seafood.
“For more than 30 years, Knight has built an exceptional team of experts known for their outstanding customer service and technical excellence and together we will provide unmatched farm to fork food safety and quality services that support the growth of our customers locally as well as globally,” said David Richardson, Vice President - Europe, the Middle East and Africa, NSF International Global Food Division.
To learn more about the NSF Global Food Division, visit the NSF Food Safety website or contact us at foodsafetysolutions@nsf.org or +1 877-893-1325.
Editor’s note: To set up an interview:
UK media can contact: Chris Slack at cslack@nsf.org or +44 (0) 1993 885684.
U.S. media can contact: Greta Houlahan at media@nsf.org or +1 734-913-5723.
About Knight: Located in Northwich UK, Knight International Inspectorate Ltd provides high quality certifications for food safety and quality including GFSI (Global Food Safety Initiative), ISO Quality Management Systems Certification and specific industry schemes such as RSPO (Round Table Sustainable Palm Oil), FSSC 22000 (Food & Packaging) and PS 9000 (Pharmaceutical Standard).
About NSF International: NSF International is a global independent organization that writes standards, and tests and certifies products for the food, water and consumer goods industries to minimize adverse health effects and protect the environment (nsf.org). Founded in 1944, NSF is committed to protecting human health and safety worldwide.
The NSF Global Food Division provides expertise and accredited services across all supply chain sectors, from agriculture, produce, processing, distribution and dairy, to seafood, retail and restaurants. Services include Global Food Safety Initiative (GFSI) certification (SQF, BRC, GLOBALG.A.P., FSSC, IFS, BAP and CanadaGAP), plus expert auditing, consulting and technical services, HACCP validation and inspection, organic food certification through Quality Assurance International (QAI), and specialty food verification and certification (including Non-GMO Project and gluten-free).. NSF is also the leading certifier of foodservice equipment, nonfood compounds and bottled water/beverages.