On November 30th, 2023, MabPlex International Co., Ltd. (MabPlex) once again passed an EMA QP on-site audit. This marks MabPlex’ s third successful EMA QP on-site audit.
The audit was conducted in support of a USA-based Client’s ADC program. The on-site inspection standards were also compliant with FDA and ICH regulations, covering equipment, validations, documents, and records relevant to the FDA’s six major systems. Compliance was also verified with the EMA’s new version appendix regarding aseptic medicinal products. This is MabPlex’s first compliance audit since the EMA appendix was formally implemented on August 25th, 2023.
To ensure full compliance of our Client’s products and remain internationally competitive, MabPlex has established a Quality system in accordance with requirements from FDA, EMA, TGA, NMPA, PIC/S, ICH, and other regulations both internationally and domestically. The company has undergone more than 180 audits.
With our commitment to satisfying the needs of both customers and regulatory authorities, MabPlex plans to further enhance its quality management standards in the future. Our mandate is to provide the highest level of CDMO services for our partners.
