Ever since the inception, Henlius has established a quality management system in line with international quality standards, which covers the entire product life cycle, from research and development to material management, product manufacturing, quality control, product supply management and particularly, product post-marketing surveillance. The system lays the foundation to commercialise products in multiple countries and regions.
Xuhui Manufacturing Facility has passed on-site inspections and / or audits conducted by the NMPA, EMA, the European United (EU) QP and international commercial partners such as Accord Healthcare and Cipla, with the production capacity for the current clinical and commercial stage. The drug substance (DS) line and drug product (DP) line for 汉曲优® (HLX02, trastuzumab injection, Zercepac® in the EU) have successfully passed China GMP compliance on-site inspection and EU GMP on-site inspection. Henlius received two EU GMP Certificates (Certificate of GMP Compliance of a Manufacturer) from Poland’s Chief Pharmaceutical Inspector. In September 2020, the drug substance (DS) line and drug product (DP) line for 汉达远® (HLX03, adalimumab injection) have also successfully passed China GMP compliance on-site inspection.
The Global Quality Operations department takes charge of the quality management system to ensure the realisation of the standard and the execution of the system. The demonstrated commitment to quality management will distinguish Henlius in the PRC market, highlighting the Company's long-term dedications to providing patients worldwide with access to reliable and quality therapies.