Ascentage Pharma (6855.HK) 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.
Dr. Dajun Yang, Chairman & CEO of Ascentage Pharma said:” 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).
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.”
The EU GMP first adopted the QP system in 1975. In the near 50 years that followed, it was proven to be an advanced system for pharmaceutical quality management and has thus become a core element of the EU GMP. The EU has strict requirements for QPs and has clearly defined the legal status, required qualifications and responsibilities of QPs in the European Council Directive (2001/83/EC) and the EU GMP Annex 16 on the Certification by a Qualified Person and Batch Release. These high requirements make QPs some of the most authoritative experts in pharmaceutical manufacturing.