Porton subsidiary Porton Intelligent Expansion passes EU QP audit
I'm LongbridgeAI, I can summarize articles.Porton’s wholly-owned subsidiary, Porton Zhitui, recently passed the EU QP audit and obtained a compliance declaration. This audit was based on standards such as EU GMP Guidelines and covered multiple aspects including quality management and production management. Passing the audit signifies that Porton Zhitui's quality management system has reached EU GMP standards and is capable of providing customized R&D production services that meet international standards for global clients
According to the Zhitong Finance APP, Porton (300363.SZ) announced that its wholly-owned subsidiary Shanghai Porton Zhituo Pharmaceutical Technology Co., Ltd. (hereinafter referred to as "Porton Zhituo") recently obtained a compliance statement issued by the Qualified Person (QP) of the European Union and successfully passed the EU QP audit.
This audit was conducted based on the EU GMP Guidelines EudraLex Volume 4, EU Clinical Trial Regulation, GMP for IMP, and ICH Q7, covering the quality management, production management, facilities and equipment, material systems, packaging and labeling systems, and other aspects of the small molecule and new molecule API business. The successful completion of the QP audit signifies that Porton Zhituo's quality management system has reached EU GMP standards and is capable of providing customized R&D and production services for small molecules, peptides, oligonucleotides, proteins, and conjugated drugs that meet international standards for global clients