recently, tot biopharm received official notices of gmp certification from egyptian food and drug administration and indonesian food and drug administration (indonesia is a member of pic/s organization), respectively, stating that bevacizumab injection developed and manufactured by the company had successfully passed the gmp certification in egypt and indonesia.
tot biopharm's quality management system was established according to the gmp standards of china, the united states and the european union. the company’s large-scale commercialization base of biopharmaceuticals in suzhou, jiangsu province, had passed gmp compliance inspection in china (2021) and qp audit in the european union (2022) previously. this time, it was recognized by indonesian and egyptian drug regulatory authorities, which means that the company's quality management system has also passed pic/s and who gmp overseas certification, further laying a solid foundation for overseas cdmo business development.
high-standard quality system and complete commercialization ability
tot biopharm currently has four complete commercial production lines, with an annual production capacity of 300,000 liters of antibody drug substance, and also has flexible production lines and sufficient production capacity. international leading and large-scale commercial production lines of adc drug product have also been constructed and put into operation, with an annual production capacity of over 5 million bottles. the commercial strength of cdmo continues to increase. at the same time, the company is committed to innovative and high-quality production and management, continuously improves its international quality management system, strengthens the establishment of system documents and implements them effectively, in order to truly escort customers’ projects.
in the future, based on high-standard quality management system and complete and flexible large-scale commercialization capability, tot biopharm will also continue to explore the international cdmo market, deepen cooperation with global customers to jointly promote the development of biomedical industry, and contribute to the cause of human life and health.
about pic/s
the pharmaceutical inspection cooperation scheme (pic/s) is a cooperative organization consisting of drug inspection agencies in more than 50 countries and regions, with members all over europe, africa, america, asia and australia. it has established cooperative relations with many international organizations such as european medicines agency (ema), the international council for harmonisation of technical requirements for pharmaceuticals for human use (ich) and world health organization (who).
as an authoritative organization in the field of international drug inspection, pic/s coordinates and unifies drug gmp standards in various countries by formulating internationally accepted drug gmp guidelines, and promotes cooperation and mutual trust among drug regulatory agencies in various countries. the gmp guidelines issued by pic/s have become internationally accepted guidelines and gold standards.