PromoCell Obtains EXCiPACT Certification
PromoCell receives EXCiPACT certification as manufacturer of pharmaceutical excipients to Good Manufacturing Practice (GMP) standards.
FREMONT, CA: PromoCell, one of the leading European manufacturers of human cell culture and cell biology products, has announced the successful completion of a rigorous EXCiPACT compliance audit that certifies the organization as a manufacturer of pharmaceutical excipients to Good Manufacturing Practice (GMP) requirements.
“The EXCiPACT certification scheme for pharmaceutical excipients provides a GMP standard that is accepted worldwide and builds on PromoCells existing ISO 9001:2015 quality management system,” says Dörte Keimer, Head of Quality Assurance at PromoCell. “Furthermore, this certification is also compliant with the widely established ANSI 363:2016 standard. To achieve EXCiPACT GMP certification, PromoCell was required to demonstrate that its pharmaceutical excipients are manufactured according to the GMP guidelines, as well as ensuring compliance in our raw material supply chain, production environment, production processes and storage conditions.”
With 30 years of experience, the organization is internationally known for providing scientists with the resources and preparation they need for ground-breaking research. Both PromoCell goods conform with the highest ethical and legal requirements. By compliance with European biomedical conventions, the company respects human rights and the dignity of donors and is equally committed to the quality of its products, training, and customer services.
“The EXCiPACT certification brings several benefits to PromoCells customers. It minimizes risk by ensuring the high quality of the cell culture media and reagents portfolios when used as pharmaceutical excipients,” says Dr. Irma Börcsök, CEO of PromoCell. “It also enables PromoCell to attend the growing demand of researchers planning to work under a regulatory environment by providing tailor-made cell culture media and reagents based on these regulatory requirements. This is achieved by a streamlined definition of raw material specifications and documentation required from our customers, thus reducing the regulatory burden, and ultimately saving cost and time. Thanks to this certification, PromoCell will make important contributions in the transition from research to application.”