On November 30th, 2023, Yantai MabPlex International Co., Ltd. (referred to as “MabPlex”) once again passed the EU QP on-site audit. This marks MabPlex’ s third successful EU QP on-site audit.
The audit was conducted for an ADC project of a U.S. client. The on-site inspection standards not only had to comply with EU GMP and related regulations but also meet the requirements of FDA cGMP and ICH regulations. The audit content covered on-site, validation, documents, and records related to the FDA’s six major systems. It also included EU GMP regulations, especially the compliance audit of the EU GMP new version appendix on aseptic medicinal products. This is MabPlex’ s first EU new version regulatory compliance audit since the EU appendix was formally implemented on August 25th, 2023.
To ensure the quality compliance of customer products, adherence to production processes, and enhance international competitiveness, MabPlex has established a quality system in accordance with regulatory requirements from FDA, EU, NMPA, PIC/S, ICH, and other international and domestic regulations. The company has undergone more than 180 audits.
With the commitment to satisfying both customers and regulatory authorities, MabPlex plans to further strengthen its quality management standards in the future. The aim is to provide high-quality CDMO (Contract Development and Manufacturing Organization) services for its partners.
