Grace European Facility Receives GMP Excipient Certification for SYLOID® FP Silica Gel

WORMS, GERMANY – May 26, 2015 – W. R. Grace & Co. (NYSE: GRA) announces that its manufacturing facility in Worms, Germany has received good manufacturing practice (GMP) certification from EXCiPACT™, an independent organization that certifies manufacturers, suppliers, and distributors of pharmaceutical excipients.

All three Grace facilities that produce its SYLOID® FP brand of pharmaceutical grade excipient silica gels have now received GMP certification, following the Curtis Bay, Maryland (USA) and Sorocaba, Brazil locations. The certification provides Grace customers an independent verification of quality, ensuring product safety while minimizing overall supply chain costs.

“This certification provides our customers with an extra level of certainty about the quality and standards used by our silica manufacturing facilities,” said Adam Grose, Vice President and General Manager of Grace Discovery Sciences. “GMP certification is increasingly important in pharmaceutical manufacturing to ensure the highest standards for safety and performance of all ingredients in drug production. Also, this certification removes an auditing requirement, which saves our customers time and money.”

Five years ago, Grace’s Curtis Bay facility received the first GMP certification ever issued from an IPEC-sanctioned audit, setting the standard for the industry.

EXCiPACT is a voluntary, self-regulated initiative of the global pharmaceutical excipient industry, supported by manufacturers, distributors, and pre-formulators. The organization ensures that cGMP and cGDP requirements are applied to pharmaceutical excipients through a recognized auditing and certification process, thereby increasing safety, reliability, and transparency of the supply chain.  Certification ensures quality and efficacy in pharmaceutical excipients, promoting their best use in medicines as a means of improving patient treatment and safety.

For over 40 years, Grace has been manufacturing silica excipients for the pharmaceutical and related industries. More recently, there is a focus on drug delivery applications and utilizing mesoporous silica-based technology to enhance the oral bioavailability of poorly water-soluble active pharmaceutical ingredients.

 

Grace European Facility Receives GMP Excipient Certification for SYLOID® FP Silica Gel, May 26, 2015,  https://investor.grace.com/news/news-details/2015/Grace-European-Facility-Receives-GMP-Excipient-Certification-for-SYLOID-FP-Silica-Gel/default.aspx