In an ideal world, we would supply allergens with a quantified biologic activity. Unfortunately, science cannot define this biological activity. To secure our production process we have defined parameters to set our specifications, which we can measure and document.
To meet the regulations and demands of regulators we can provide you with the full supply chain of our products. Information about the manufacturing location, origin of the material (biological/ synthetic), packaging and handling environment employed, details of any toxic substances such as solvents or heavy metal catalysts used during manufacture, and change-control elements. We constantly learn how to work with ever changing guidelines.
To meet GMP regulations Citeq has 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.
We have defined parameters to set our specifications, which we can measure and document. The parameters are the results of 40 years’ experience in preparation of whole cultures and mite bodies. We are confident this illustrates what is meant by “content uniformity”. Next to these parameters, we comply to US and European regulations and guidelines. Our samples contain less than 1% impurities (FDA). We do not use any substances listed in the EU regulations.
If you have established the desired quality for the required raw material for each application we can supply our materials with the best fit. Our quality systems incorporate the important aspects of GMP standards to meet regulations without over-engineering and adding unnecessary cost to the product. In-process controls are important to maintain healthy cultures and to determine the optimal harvest-time, both for whole cultures and mite bodies. Trend analyses are important indicators for the quality of both the analysis and the final product.