GenScript ProBio has passed the European Union Qualified Person (QP) Certification Audit

12 November 2021 | Friday | News

GenScript ProBio announces that the Nanjing antibody and protein manufacturing facility has successfully passed an audit for certification by a European Union Qualified Person (QP) in October 2021.

This means that GenScript ProBio Nanjing's manufacturing facility is European pharmaceutical GMP compliant and can provide high-quality clinical products and CMC services to European and international customers. This is GenScript ProBio's first QP audit, and it is a continuous improvement in the quality system's compliance status with Chinese national and international regulatory requirements. The facility has undergon various successful audits by third-party clients and auditors from China, the United States, Asia and, now,Europe.

The lead auditor supports clients in the pharmaceutical and biotechnology sectors in clinical research, development and commercial manufacturing. Due to COVID-19 travel restrictions, the audit was conducted remotely by two auditors over a two-day period. The inspection was carried out in accordance with the EudraLex Volume 4 (European Union Good Manufacturing Practice or EU GMP) and CHI (International Council for the Harmonization of Technical Requirements for the Registration of Medicinal Products for Human Use) guidelines. The audit covered the production system, facilities and equipment management, QC, QA, materiel management, CSV and other systems. The auditors indicated that they found that the facility was operating at a very high level of GMP compliance, that staff were well informed, and that the quality systems were adequately structured and met current scientific and recognized standards. They concluded that the facility was operating in full compliance with EU standards and regulatory directives.

GenScript ProBio Nanjing GMP's manufacturing center follows the state-of-the-art international concept and is a true "zero crossover, one-way flow" factory, which meets the regulatory requirements of the FDA, EMA and NMPA. Strict physical insulation measures are adopted throughout the facility, which ensures that several samples are manufactured at the same time. In September 2021, GenScript ProBio announced the signing of a clinical manufacturing service contract with a German company called Synimmune.


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