Porton Pharma Solutions Gains EU QP Approval for Shanghai Fengxian Site

• Porton’s Shanghai Fengxian Manufacturing Site has passed a five-day EU Qualified Person (QP) audit.

• The site is now approved to offer CDMO services for small molecules, peptides, oligonucleotides, proteins, and conjugates to global markets.

Porton Pharma Solutions Ltd. has announced the successful completion of a Qualified Person (QP) audit at its Shanghai Fengxian Manufacturing Site, confirming the site’s compliance with EU GMP standards. The five-day audit, conducted by a German QP auditor, assessed quality systems, production practices, facility equipment, and packaging operations.

The audit determined that the site meets the requirements set by EudraLex Volume 4, the EU Clinical Trial Regulation, GMP for Investigational Medicinal Products (IMP), and ICH Q7. This certification allows Porton to provide CDMO services to global clients across a range of modalities including small molecules, peptides, oligonucleotides, proteins, and conjugated drugs.

The company emphasised that this outcome is a reflection of its global quality policy, stating: “One Porton, One Quality.” With more than ten R&D and manufacturing locations across China, the United States, and Europe, Porton maintains a unified and consistent quality management framework.

Porton highlighted that the Shanghai site’s approval not only supports its commitment to global compliance but also enhances its ability to deliver contract manufacturing services to international standards. The company plans to further invest in strengthening its quality management systems and maintain high levels of performance across its global network.