February 8, 2012
STROUDSBURG, Pa.Assured Calibration and Laboratory Accreditation Select Services (ACLASS) accredited STR-Registrar under its good manufacturing practices (GMP) factory assessment program for and dietary supplement, over-the-counter (OTC) drugs and medical device manufacturers. Accreditation for cosmetics and non-regulated products is expected by the end of the month. According to STR-R, no other certification body has its GMP audit program accredited by an independent, outside organization.
The accreditation ensures STR-R's 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. 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," said 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-Rs auditors 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.
Learn more on choosing a GMP-compliant contract manufacturer with this on-demand video, "GMP Compliance and Contract Manufacturers: The Legal View."
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