Quality control and quality assurance are essential elements of apceth Biopharma’s production, ensuring the quality and consistency of every batch of every cell product. Each step of the manufacturing process is strictly controlled and carefully documented.
apceth Biopharma’s experienced Qualified Persons (QP) are responsible for the final product release, according to all current EU Directives and GMP-guidelines, including FDA and other regulatory territories.
Through external GMP/GLP audits performed by our qualified personnel, apceth Biopharma ensures that all external partners fully comply with the high EU regulatory standards, with the FDA guidelines and with apceth Biopharma’s own stringent requirements.
The quality-by-design concept and the risk-management based approach embedded in all stages of apceth’s pharmaceutical development minimize the risk of potential setbacks.
The combination of a full range of quality management components with apceth Biopharma’s quality control procedures enables tight control of the manufacturing process, full traceability throughout the production procedure and the highest level of cGMP compliance.
In this way, apceth Biopharma is able to provide a robust manufacturing process and to guarantee reliable excellence in all our cell products and highly consistent batch-to-batch quality.