Quality & Compliance

· In accordance with cGMP and ICH guidelines, develop and manufacture active pharmaceutical ingredients and pharmaceuticals that meet the regulatory requirements of the European Union, the United States, Japan and China, as well as high quality standards for human use.

· Drive continuous improvement through annual internal self-inspections;

· Pursue continuous improvement via hundreds of customer audits every year;

· Since 2020, in accordance with remote audit guidelines issued by EMA, USFDA and TGA, we have taken the lead domestically in achieving full Wi-Fi coverage within GMP production areas. A relatively complete remote audit system has been gradually established from both hardware and software dimensions.

· Strictly comply with relevant laws and regulations issued by the World Health Organization (WHO);

· Establish the quality management system in line with mainstream GMP standards including China’s Pharmaceutical GMP, US cGMP, EU GMP, PIC/S guidelines and ICH guidelines;

· Set up an independent Quality Assurance department, and implement full coverage management of quality system elements across all GMP-related activities;

· Construct cGMP-compliant production workshops meeting international standards (covering conventional APIs, high-potency APIs, biological products, beta-lactam APIs, chemical macromolecules, continuous manufacturing technology, biocatalyst technology, and pharmaceutical formulations), and consistently maintain stringent quality supervision requirements;

· Carry out full-lifecycle product management covering R&D, technology transfer, clinical-stage and commercial-stage manufacturing;

· Systematically deploy various GMP computerized systems to cover all aspects of GMP management;

· Fully ensure that manufactured products consistently meet predefined requirements and quality specifications.