EMEA
Proven in facilitating registration and change of source materials.
Our certificates of analysis are according to EMEA/CHMP/BWP/304831/2007 and European Pharmacopeia guidelines. The following items are described:
Biological
Description of collection or way of producing
Biological identity
Biochemical
All paramaters
ELISA
Pharmaceutical
Water content
Heavy metals
Description of the form color
GMP
Citeq Biologics anticipates the GMP guidelines that will apply to allergen production in the near future. We are familiar with GMP practices, because of previous experience with GMP in biopharmaceutical companies. To meet the GMP regulations, we implemented several measures:
- Our mites are cultivated on defined media without any animal or human components.
- Mammals are kept within a maximum barrier with strict personnel access procedures.
- Our documentation is GMP ready. All chemical, microbiological, and plant source components of the mite cultivation media are well documented.
- We provide full documentation with our products.
Citeq Biologics meets the European GMP guidelines. In addition, we have an anticipative attitude towards all new guidelines. It is our goal to always stay ahead of new quality standards.
