Ablynx is a biopharmaceutical company dedicated to the development of the next generation of biological drugs: Nanobodies® (patented therapeutic proteins based on single-chain antibody fragments). Their products are used for the treatment of diseases such as inflammation, haematology, respiratory diseases, immuno-oncology and oncology.
The pharmaceutical sector is strictly controlled and must comply with very specific legislation. The production process of medicines is subject to very strict legislation. Patient safety and data integrity, compliance with legislation is monitored. Failing an audit can have serious consequences, from high fines to even completely shutting down production.
Ablynx called on Ordina’s Quality & Compliance expertise to prepare and conduct a Belgian audit. Ordina’s Quality consultants have a thorough knowledge of the regulations and legislation (cGxP, CFR21 Part 11, ISO, etc.) and can estimate data integrity risks for systems that store data. They guide the customer through their qualification and validation process without any problems.
Ablynx successfully passed the audit, but above all meets the strict quality requirements. Ordina Q consultants will continue to fine-tune guidelines, procedures and customer training in the future