W. R. Grace & Co. has earned Good Manufacturing Practices (GMP) certification of its facility in Baltimore, Maryland. 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,” commented Greg Poling, Vice President, W. R. Grace & Co. 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 ten 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.