W.R. Grace & Company has earned Good Manufacturing Practices (GMP) certification of its facility in Baltimore, Md. The certification encompasses Grace's Quality Management System that includes the standards, procedures and manufacturing operations used by the company in the production of pharmaceutical grade silica (commonly marketed by Grace under the SYLOID brand name).
The certification is a verification that Grace's Quality Management System meets the requirements of the Joint International Pharmaceutical Excipients Council – Pharmaceutical Quality Group (IPEC-PQG) GMP Guide for Pharmaceutical Excipients. Pharmaceutical excipients are inactive ingredients (additives) used in drug formulations.
The certification included a two-day onsite audit of Grace's Quality Management System and the company's production, maintenance, laboratory and warehouse operations by International Pharmaceutical Excipients Auditing (IPEA), Inc. The audit was reviewed on February 22 by a panel of industry experts assembled by IPEA Inc., which came back with a recommendation for certification. This is the first certification for conformance to Excipient GMP granted by IPEA, Inc. for a pharmaceutical excipient in the world.
"We are extremely pleased to earn this certification," said Greg Poling, vice president, W.R. Grace & Company, and president, Grace Davison. "Our customers can be assured that we maintain the highest levels of quality. We continuously test ourselves and our business processes with this audit being an example of that dedication."
Grace's current manufacturing operations in Baltimore consist of 10 production areas that produce hundreds of products from four general product lines: fluid cracking catalysts, hydroprocessing catalysts, polyolefin catalysts and silicas. Production processes include crystallization, mixing, filtering and washing, drying and calcination (high-temperature drying).
Grace markets to customers in the life science, pharmaceutical, anesthesiology, forensic and biotechnology industries through Grace Davison Discovery Sciences, an established leader in silica chromatographic media and detector technologies. Products include liquid chromatography columns, detectors, instruments, accessories, bulk media and purification systems.
Grace is a leading global supplier of catalysts and other products to petroleum refiners; catalysts for the manufacture of plastics; silica-based engineered and specialty materials for a wide range of industrial applications; sealants and coatings for food and beverage packaging, and specialty chemicals, additives and building materials for commercial and residential construction. Founded in 1854, Grace has operations in more than 40 countries.
