STR-Registrar Becomes First Company to Offer ACLASS-Accredited GMP Audits
Receives ACLASS-Accreditation for OTC Drugs, Medical Device and Dietary Supplement Categories First; More Industry Specific Scopes to Follow
(firmenpresse) - STROUDSBURG, PA -- (Marketwire) -- 02/06/12 -- STR-Registrar (STR-R), a leading provider of management system registration services, recently became the first certification body to receive accreditation from ACLASS for its good manufacturing practices (GMP) factory assessment program for over-the-counter (OTC) drugs, medical device and dietary supplement manufacturers. Accreditation for cosmetics and non-regulated products is expected by the end of the month. No other certification body besides STR-R has ever had its GMP audit program accredited by an independent, outside organization.
Retailers and manufacturers that use STR-R will benefit from knowing that their GMP audits of quality systems and supplier facilities meet international guidelines, are conducted by experts with specific understanding of their products, and have been vetted by the world's leading authority on standardization and quality. ACLASS provides accreditation to ISO/IEC 17020 for inspection bodies and is part of the ANSI-ASQ National Accreditation Board.
"ACLASS-accredited GMP audits are a win-win for retailers and manufacturers in this global marketplace. Having an approved GMP audit process provides a level of standardization and quality that the industry has wanted and needed for quite some time," said Bryce E. Carson, Sr., General Manager of STR-R. "This helps companies achieve higher levels of quality and greater confidence in the integrity of their brands in a more efficient and cost effective manner."
In 2012, STR-R expects to certify at least 90 companies under the new ACLASS-accredited GMP audit program. STR-R's accredited auditors will assess how well a retailer, manufacturer, and supplier conforms with product regulations, standards, and specifications. This includes examining materials, products, installations, plants, processes, work procedures, and/or services. Inspection parameters may include quality, safety, quantity, fitness for use, and continued safety compliance of plant and/or systems in operation. The entire process takes approximately one to two months to complete for initial certification and then requires annual audits to maintain factory specific certification.
Assured Calibration and Laboratory Accreditation Select Services (ACLASS) provides accreditation to ISO/IEC 17025 for testing and calibration laboratories, ISO/IEC 17020 for inspection bodies, ISO Guide 34 for reference material producers, and ISO/IEC 17043 for proficiency testing providers. ACLASS also provides ISO 17025 training and training on other topics. ACLASS is internationally recognized as a signatory of multilateral recognition arrangements that facilitate acceptance of test and calibration data internationally and is one of two brands of the ANSI-ASQ National Accreditation Board, a non-profit, non-governmental organization that provides accreditation services to public- and private-sector organizations and is jointly owned by the American National Standards Institute and the American Society for Quality.
STR-Registrar (STR-R) is an ANSI-ASQ National Accreditation Board (ANAB) accredited international provider of management system certification and registration services. In addition to ANSI ISO/IEC Guide 65 Accreditation, STR-R maintains accreditations and offers ISO 9001 and AS9100, management system certifications as well as ANSI/AIHA Z10 and OHSAS 18001 Occupational Health and Safety management system certifications. Further accreditations held include SA8000, Social Accountability International granted by Social Accountability Accreditation Services (SAAS) and ANSI Guide 65 Accreditation for the provision of GFSI (Global Food Safety Initiative) benchmarked standard, SQF2000 Certification for food manufacturing facilities. STR-R is a division of the UL family of companies. Additional information about STR-R may be found at .
UL is a premier global independent safety science company with more than 117 years of history. Employing more than 6,800 professionals in over 96 countries, UL has five distinct business units -- Product Safety, Environment, Life & Health, University, and Verification Services -- to meet the expanding needs of our customers and to deliver on our public safety mission. Additional information about UL may be found at .
Contact:
Amy Blumenthal
Blumenthal & Associates
617-879-1511
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Datum: 06.02.2012 - 09:47 Uhr
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