25 April 2023 | Tuesday | News
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Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, today announced that it recently received a zero-deficiency report from the GMP compliance audit of Ascentage Pharma's Global Manufacturing Center by a Qualified Person (QP) of the European Union (EU). This successful audit indicates that the company's Global Manufacturing Center and quality management system implemented at the site are now compliant with the standards of the EU GMP, marking the achievement of a major milestone that will pave the way for the company's continued global expansion.
In March 2023, a QP of the EU carried out an inspection at Ascentage Pharma's Global Manufacturing Center over a four-day period. Under guidance by the EudraLex Volume 4 regulations (Guidelines for Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Volume 4), the audit covered quality assurance, manufacturing processes, lab control, material management, facilities and equipment, data integrity, and IT systems of the manufacturing site.
The auditor spoke highly of Ascentage Pharma's Global Manufacturing Center at the end of the audit, and confirmed that the site possesses a high-standard quality management system, facilities, equipment, as well as experienced staff that make the site completely compliant with the requirements of the EU GMP. As a result, Ascentage Pharma received a zero-deficiency audit report from the EU QP that will pave the way for the manufacturing and global commercialization of the company's innovative drugs.
"Ascentage Pharma's Global Manufacturing Center, which was granted a Drug Manufacturing License (Certificate A) in China in November 2022, has built a quality management system that is compliant with GMP standards of China, the US, the EU, and guiding principles of the ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)," said Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma. "The clearance from this inspection by the EU QP indicates approval by a major international certification body for the quality management system implemented at our Global Manufacturing Center. It is a significant milestone in our global expansion and it will accelerate our transition into a fully vertically-integrated biopharma. Remaining steadfastly committed to the mission of addressing unmet clinical needs in China and around the world, we will forge ahead with the development of innovative drugs and observe the most stringent quality management to bring more high-quality novel therapeutics to patients around the world."