Making quality count
Quality counts for everything. It gives our customers the assurance of knowing that our entire process is certified to applicable standards and meets all requirements. To assure consistency in manufacturing quality we always use standard operating procedures, stringent processes and controls to govern the handling of our allergen source materials. This ensures that all our manufacturing processes are reliable and reproducible. Furthermore, we are continously audited by our customers to confirm the high quality level of our maunfacturing processes as well as our quality system.
Allergon is certified according to ISO 9001:2008 and we have been inspected by the FDA, compling with Code of Federal Regulations, since the 1980's. We are able to assist our customers with product references, required documentation and supply Site Master Files on request to the authorities. Allergon comppy with cGMP and are inspected continuosly in accordance with the ISO 9001:2008 standard.
We stringently adhere to the following regulations:
- The European Pharmacopoeia monograph Allergen Products
- The US Code of Federal Regulations 21, with respect to allergenic products, source materials
- The EMEA guidelines on Allergen Products
- The EU guidelines on current Good Manufacturing Practice (cGMP)
- Good Agricultural Practice (GAP)
- Swedish Environmental code (SFS) 1998:808