According to the EXCiPACT Good Manufacturing Practice (GMP) Certification Standard, Corel Pharma Chem sites in Kadi, Mehsana and Gujarat India, comply with the requirements for manufacturing pharmaceutical excipients. The scope of certification covers manufacture of carbomers, methacrylic acid copolymers and ready-to-use coating materials, comprising methacrylic acid copolymer mixtures or other film former with plasticizer, opacifier and color for the pharmaceutical industry.
EU and US pharmaceutical regulations require drug manufacturers to either conduct their own audits or commission third-party physical audits of all their starting material suppliers to demonstrate GMP and/or Good Distribution Practice (GDP) compliance. The independent, high-quality, third-party EXCiPACT certification scheme is already helping users and suppliers to reduce their audit burden, save costs and assure quality.
Jeff Dowson, SGS Global Head of International Sales and Accounts, said: "This certification is an important one, especially in the realm of excipient supply. Not only does it signify that this organization complies with the appropriate regulations, it also proves that all materials being produced in this site are safe, as confirmed by SGS."
For full details of all sites that have been EXCiPACT certified to date in 16 countries (Canada, China, Belgium, France, Germany, India, Israel, Italy, Japan, Saudi Arabia, Singapore, Spain, Switzerland, The Netherlands, UK and USA) see EXCiPACT Certificates.
To learn more about obtaining EXCiPACT Certification, contact:
Global Head International Sales and Accounts
t: +44 (0) 7889 939 725
EXCiPACT asbl is a non-profit organization that owns and manages oversight of an independent, high-quality, third-party certification scheme available to pharmaceutical excipient manufacturers and distributors worldwide.
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 95,000 employees, SGS operates a network of over 2,400 offices and laboratories around the world.