QUALITY STANDARDS

Obtaining raw materials

The raw materials used comply with all the applicable standards required from an Active Pharmaceutical Ingredient (API). In addition, the medicinal plants are treated following the Good Agricultural and Collection Practices (GACP) and the specific monograph that requires:

1

Traceability

Guaranteeing quality throughout all stages of the plant's processing, together with the chronological information regarding its origins and position, so that it is always possible to reconstruct the origin and subsequent actions carried out in all of the stages.
2

Authenticity and reproducibility of the ingredients

Checking by means of all available identification techniques, be they botanic, chemical or biological, that there are no errors in the characterization or no possible cross contaminations and that the quantities of the active substance are bioequivalent.
3

Inter or intraspecific variability (country of origin)

To guarantee the homogeneity of the natural raw materials so as to avoid variability due to environmental factors, geographical factors, etc. For this reason, all of the parameters are monitored, such as time of harvest, botanical characteristics, soil characteristics, storage, etc.
4

Tuber

Cultivation and harvesting of plant/tuber follow the specific monograph for Cyclamen europaeum L. and the European regulations GACP (Good Agricultural and Collection Practices). Physical, chemical and microbiological analysis of tubers, equivalent to those used on an API (Active Pharmaceutical Ingredient).
5

Processing

It is critical that the maximum degree of control is applied to ensure appropriate transportation, storage, drying, etc.
Cyclamen

EXTRACT

Manufacture and control of the extract: optimization and validation in order to obtain optimum conditions of conservation.

FDA has completed their administrative review of our Type II Drug Master File for Extract of Cyclamen europaeum L., and has assigned it the identification number # 20641.

FINAL ANALYSES

These are controlled by means of all the necessary identification techniques, one of which is HPLC chromatography (qualitative and quantitative) to ensure there has been no loss of quality and that the product has the desired requirements. In the same vein, the most demanding microbiological controls for raw materials are applied.

“European requirements are met in obtaining the raw material as well as in manufacturing the finished product.”

MANUFACTURE OF THE FINISHED PRODUCT

Finished Product is manufactured (lyophilization and packaging) in a Spanish pharmaceutical manufacturing site possessing the European GMP certificate (Good Manufacturing Practices). This certification affects all the fields related to product quality: personnel, installations, equipment, quality system, quality control, etc.

Lyophilization was selected (even though there are simpler processes) due to the greater guarantee of quality it provides. In actual fact, lyophilization offers some important advantages:

  • It facilitates dosage standardization.
  • It significantly prolongs product stability and its average life.
  • It avoids microbial proliferation and enzymatic activity of deterioration.
  • It enables conservation under habitual environmental conditions.
  • Product reconstitution is fast and easy, due to the porous structure of the lyophilized extract.