(STR-R: Stroudsburg, PA) -- 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 nonregulated products is expected by the end of the month.
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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,” says Bryce E. Carson, Sr., general manager of STR-R. “Having an approved GMP audit process provides a level of standardization and quality that the industry has wanted and needed for quite some time. 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 services. Inspection parameters may include quality, safety, quantity, fitness for use, and continued safety compliance of plant 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.
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