recently, tot biopharm (stock code: 1875.hk)
gained the compliance inspection report approved by the eu qualified person
(qp). tot biopharm’s commercial antibody and antibody drug conjugates (adc)
manufacturing site in suzhou industrial park headquarters have passed the qp
audit with zero defect, which proves that the company’s commercial
manufacturing site and quality management system comply with eu gmp standards.
this audit was conducted eu (ireland) qp in
accordance with eudralex vol 4 (eu gmp) and international conference on
harmonization of requirements for registration pharmaceuticals for human use (ich)
guidelines for antibody intermediate, adc ds and adc dp of an adc drug developed by tot biopharm. the audit covered various
aspects such as manufacture management system, quality management system, plant
facility and equipment management system, validation and computerization
system, validation and management of data integrity, material management
system, testing and release management.
tot biopharm passed this audit in one go with
zero defect and was highly recognized by the auditors. this is one of the few
commercialization sites in china that have passed the eu qp certification for
both antibody and adc drugs; it is also another milestone in the quality
management system of tot biopharm after passing the gmp on-site verification in
china, which lays a solid foundation for tot biopharm to provide one-stop cdmo
services for biologics that meet the requirements of ema, nmpa and fda drug
regulations to its clients.
dr.
jun liu, ceo of tot biopharm, said:
the eu qp audit is one of the important steps
in the globalization strategy of tot biopharm. the antibody drug manufacture
plant and the chemical oral preparation manufacture plant of tot biopharm have
passed the on-site verification of china’s drug registration and manufacture
and gmp compliance. the passing of the eu qp audit proves that the quality
management system of tot biopharm has been recognized by international
professional organizations.
in the future, tot biopharm will strengthen its
technology development and commercialization manufacture capacity, and continue
to strengthen the advantages of quality management system to provide one-stop
cdmo services for domestic and foreign clients with higher efficiency and
better quality, empowering partners and driving high-quality industrial
development.