We adhere to the following standards and guidelines:
- European cGMPs (2001/83/EC, 2003/94/EC, 2003/63/EC)
- U.S. cGMPs (21 Code of Federal Regulations Part 210 and 211 + annexes)
- ICH Guidelines (Good Manufacturing Guidelines for Active Pharmaceutical Ingredients and Drug Products)
Our biologics custom manufacturing sites in Belgium (Seneffe and Gosselies) are inspected on a regular basis by Belgian authorities with last inspections in 2012 for Gosselies and in 2013 for Seneffe. These sites also undergo approximately 10 customers’ audits each year.
The Quality team ensures that our staff is continuously trained, and that our equipment and utilities are qualified, maintained and ready to ensure production, testing, and storage in controlled conditions.
The Quality Control department validates analytical methods and performs ICH stability studies.
Our analytical method validation activities are performed in compliance with ICH Q2 (R1) guidelines, FDA and European Medicines Agency (EMA) requirements.
All the current analytical methods are used to assess the:
- Identity (ELISA, Western-Blot, HPLC…)
- Quantity (UV, HPLC, Lowry, TCID50…)
- Purity and product-related impurities (SDS-PAGE, IEF, HPLC…)
- Process-related impurities (residual DNA and residual HCP)
- Potency (in vitro or in vivo test, infectious titers…)
- Compliance to general chapter of Pharmacopoeia (bioburden, pH, osmolality, LAL, sterility test…)
Depending on the development stage of the project, we can propose a full or partial validation of the QC analytical tests used for the release of raw materials and/or release of the production steps, intermediates products, or final products.
We can organize the transfer of an already validated analytical method to our QC laboratory or organize the transfer to our customer’s site if the method was validated on our site.
Novasep’s QC also performs ICH stability studies including services such as: protocol design; development and validation of stability methods; long term and accelerated stability studies.
The Quality Assurance team routinely conducts internal and external audits which guarantee that internal and external operations are in compliance with appropriate regulations, guidelines, and internal procedures for the manufacture and control of biologic drug substances and drug products.
Each key service subcontractor or product provider to our company is qualified by our services in order to maintain the highest standards you can expect from us.
Our staff is ready to assist you in your drug submissions in the United States, Europe and the rest of the world.
Our storage facilities are operated under cGMP conditions and submitted to regular qualification and validation. Our equipment and services include:
- Storage capacities :
- + 4 / - 20 °C in individual equipment (fridge-freezers)
- + 4 °C in large area (2 x 15m²)
- - 20°C in large area (1 x 12m²)
- - 80°C in individual equipment (super freezers)
- - 160°C in nitrogen tank (x4)
- Back-up storage capabilities
- In-house maintenance
- Continuous monitoring of conditions
- Secure site with restricted access and complete alarm system