Suzhou Ribo Life Science Co., Ltd.，the leading innovative oligonucleotide therapeutics company in China, announced today that it has recently received the European Union Qualified Person Declaration (QPD) from the Qualified Person based on the positive results of the EU GMP audit conducted for its oligonucleotide manufacturing facilities located in Kunshan, China. The on-site QP audit included a comprehensive inspection covering the equipment and facilities, personnel training, materials management, computerized system, qualification and validation, laboratory control, manufacturing process, and quality assurance system according to the EU GMP regulations and ICH guidelines. The issuance of the QPD is a verification and confirmation that the Kunshan facilities have been established and operated in compliance with the EU GMP.
This QPD will enable Ribo to apply clinical trial application (CTA) and conduct clinical trials in EU countries, which have become increasingly important for Ribo´s globalization strategy.
"As a biotech company devoted to the research and development of innovative oligonucleotide therapeutics, Rio has always valued quality as a key element in our culture and therefore we have established the quality system to ensure that quality is built into products through all of our daily activities covering research, development and manufacturing"，commented Hongyan Zhang, Ph.D., President of Ribo,“The significance of this milestone achievement cannot be overstated in the history of our company, because it not only recognizes our quality system, but also exemplifies Ribo’s commitment to striving for excellence, and ensuring that high quality products can be developed, manufactured and accessed globally by patients in need.”