Site in Pennsylvania manufactures and distributes lake pigments for use as pharmaceutical excipients
Colorcon Inc. Westpoint site in Pennsylvania, USA, has recently been awarded an EXCiPACT GMP and GDP Certificate from SGS, one of EXCIPACT’s internationally-recognised Certification Bodies.
The Certificate demonstrates that this site manufactures and distributes lake pigments (wet and dry dispersions) and polyvinyl acetate phthalate (phthalin-coating materials) for use as pharmaceutical excipients according to the EXCiPACT Good Manufacturing Practice (GMP) and the Good Distribution Practice (GDP) Certification Standards.
EU and US pharmaceutical regulations require drug manufacturers to conduct either their own or third-party physical risk-assessment audits of all their starting material suppliers to demonstrate GMP and/or GDP compliance thus increasing the audit burden.
However, using GMP and GDP standards designed specifically for pharmaceutical excipients, the voluntary, independent, high quality, EXCiPACT Certification Scheme helps pharmaceutical excipient users and their suppliers to demonstrate their commitment to GMP/GDP, to reduce their audit burden, to save costs and to assure product quality.