Porton Shanghai Fengxian Manufacturing Site Has Passed the EU QP Audit

Porton Pharma Solutions Ltd. (hereinafter “Porton”) is glad to announce that its Shanghai Fengxian Manufacturing Site has passed the EU Qualified Person (QP) audit.

This five-day audit, led by a German QP Auditor, covers quality management, production management, plant equipment and facilities, material systems, and packaging and labeling systems of small molecule and new molecule API business. The GMP Compliance Statement declares that the quality system and facility of Shanghai Fengxian Manufacturing Site are in compliance with the standard of EU GMP Guidelines EudraLex Volume 4, EU Clinical Trial Regulation, GMP for IMP and ICH Q7.

The successful completion of the QP audit is a recognition of the quality management system of Shanghai Fengxian Manufacturing Site, demonstrating Porton's commitment to practicing high standard quality management. It marks that Shanghai Fengxian Manufacturing Site can provide CDMO services for small molecules, peptides and oligonucleotides, proteins and conjugate drugs that meet international standards to global customers.

Porton adheres to the quality management principle of "One Porton, One Quality", strictly follows the ICH guiding principles, and implements unified quality management for more than 10 R&D and manufacturing sites in China, the United States, and Europe to ensure the reliable and stable operation of the quality management system. In the future, Porton will continue to strengthen the construction of its quality management system, continuously improve its quality management capabilities, and provide high-quality and high standard CDMO services to customers.