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News 2025-12-30

Porton Achieves EU QP Certification for Chongqing Manufacturing Facility

Porton Pharma Solutions Ltd. (hereinafter “Porton”) today announced that its Chongqing Manufacturing facility has successfully completed the European Union Qualified Person (QP) certification. This achievement marks Porton’s third site to attain EU QP certification, joining its Shanghai Fengxian and Shanghai Pudong facilities in meeting the stringent quality standards required for pharmaceutical production for European markets.




This five-day audit, led by a German QP Auditor, covers quality management, production management, facility and equipment, material management, and packaging and labeling systems. The GMP Compliance Statement declares that quality system and facility of the company are in compliance with the standard of EU GMP Guidelines EudraLex Volume 4, EU Clinical Trial Regulation (536/2014), and GMP for IMP.




As an important component of Porton's Drug Product CDMO business, Chongqing Manufacturing Site has consistently adhered to the quality principle of "systemic compliance, continuous improvement, and customer orientation," focusing on quality management system development. This third certification demonstrates our unwavering commitment to consistent quality standards across all Porton sites, reinforcing our position as a preferred CDMO partner for global pharmaceutical companies seeking reliable manufacturing solutions that meet the world's most demanding regulatory requirements.

Looking forward, Porton will continue to adhere to the quality management principle of "One Porton, One Quality", and integrate quality management throughout the entire lifecycle of drugs, providing high-level end-to-end CDMO services for global customers, and enabling earlier access to good medicines.



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