Quality Management

apceth’s pharmaceutical manufacturing is an integral part of the established quality management  system.

The quality control and quality assurance are essential elements of apceth’s production. Each step of the manufacturing process is strictly controlled and carefully documented.

apceth’s two experienced Qualified Persons (QP) are responsible for the final product release according to all current EU Directives and ensures the undisputable quality and consistency of each batch of every cell product.

Through external GMP / GLP audits performed by apceth’s qualified personnel, apceth ensures that all external partners fully comply with the high EU regulatory standards and apceth’s own standards.

The “quality-by-design” concepts and the “risk-based-approach” underline all stages of apceth’s pharmaceutical development in order to minimize the danger of potential set-backs to the lowest level possible.

The interplay of all quality management components enables control over the manufacturing process and the quality of apceth’s cell product, full traceability of the production procedure as well as the highest level of cGMP compliance. In this way apceth guarantees a robust manufacturing process and an exceptional and consistent batch-to-batch quality of every cell product.