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

Traceability

Guaranteeing quality throughout all stages of the plant’s processing together with its 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.

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.

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.

Processing

It is a critical point where the maximum degree of control is applied to ensure appropriate transportation, storage,drying, etc.

Final Analyses

These are controlled by means of all the necessary identification techniques, one of which being 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.

The manufacture and control of Hartington products complies with European GMP guidelines (Good Manufacturing Practices) together with European Pharmacopeia standards, and its production installations possess the GMP certificate.