Colorcon at Stoughton, Wisconsin USA, received an EXCiPACT Goods Manufacturing Practice (GMP) certificate following an audit by SGS.
This certification covers Colorcon's manufacture of pharmaceutical sugar spheres, uniform drug layering pellets, made of sucrose and starch, for sustained or extended release dosage forms.
EXCiPACT certification demonstrates Colorcon's production of safe, high-quality and compliant pharmaceutical excipients. This award also shows the dedication of pharmaceutical companies in assuring optimum products for the market.
Commission audits are required by pharmaceutical regulations for the manufacturers of drugs and other related products, conducted either done internally or by a third-party, to show GMP compliance. The EXCiPACT certification scheme offers manufacturers, suppliers and other stakeholders a simplified audit process to assure safety and quality in the pharmaceutical supply chain.
A complex assessment process was undergone by SGS and Colorcon's auditors to become EXCiPACT-registered. Colorcon's auditors also completed the two-day EXCiPACT Auditor Training course and an examination to attest that their training and competency satisfied the requirement of the standard. As part of the process, SGS also arranged for the internal auditor's report to be verified by a third-party certification board before any certificate was issued.
Jeff Dowson, SGS Global Head of International Sales and Accounts, noted the significance of this certification, and said: "Colorcon, a company dedicated to pharmaceutical product development, aimed to provide the best-in-class quality of products while being compliant to the regulations. The growing number of certified companies like Colorcon reflects how the pharmaceutical industry values the safety of its end-users. At the same time, we were able to take part in this industry's efforts to the market through showing our expertise to certification and standards. We continually uphold the value of quality and safety in the pharmaceutical supply chain."
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SGS is the world's leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 97,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.