Home/INSIGHTS/QUALITY, IN ADDITION TO SAFETY AND EFFECTIVENESS: FUNDAMENTAL REQUIREMENTS OF THE RAW MATERIALS USED IN THE FORMULATIONS OF EYEPHARMA® PRODUCTS

QUALITY, IN ADDITION TO SAFETY AND EFFECTIVENESS: FUNDAMENTAL REQUIREMENTS OF THE RAW MATERIALS USED IN THE FORMULATIONS OF EYEPHARMA® PRODUCTS

The quality, safety and efficacy of a supplement are not concepts which may be superimposed:

  • QUALITY is determined by the characteristics of the raw material, the supply chain, the technologies and processes used for the processing of the ingredients, the controls on the raw material (botanical ingredients) and on the finished product;
  • SAFETY is primarily linked to the verification of the absence of potential contaminants typical of products of plant origin (eg pesticides, mycotoxins, toxic metals etc.), an aspect that pertains to quality, but also to the specific conditions of the organism that assumes the supplement, the dosage and the methods of intake and the possible interactions with other active ingredients, be they natural or synthetic. Therefore, it is essential to carry out preclinical toxicological studies to guarantee the use of the botanical ingredient. However, a quality supplement can have different safety profiles in different subjects and for this reason it is advisable that the intake of botanical supplements is preferably recommended and guided by the doctor or pharmacist;
  • EFFICACY, is understood to be the ability of a supplement, through its ingredients, to strengthen physiological processes:  upplements containing the same ingredient of natural origin can have different effectiveness depending on the formulation, which for example modifies its solubility.

It is clear therefore that the quality, safety and efficacy, as described, are essential requirements for a supplement to  be deemed as being of “quality”.

BUT HOW TO RECOGNISE THE QUALITY OF A BOTANICAL FOOD SUPPLEMENT?

The quality of botanical supplements is expressed by specific characteristics, which those who prescribe or recommend the products (doctors and pharmacists) and consumers must be able to verify:

1. QUALITY OF THE RAW MATERIAL:

  • identification of the plant (at least its genus and species): the plant from which the ingredient derives must be identified with certainty, through specific protocol and analyses, such as botanical checks, chromatographic profiles, or DNA analysis;
  • purification of the botanical extract: if the plant contains notoriously toxic or allergenic substances such as ginkgolic acids in the leaves of Ginkgo biloba, or unwanted substances such as simple sugars, it is important to remove these components and obtain an extract deemed purified;
  • standardization: is a process of combining different lots to ensure that the botanical extract always has the same composition of constituents in order to reduce the natural variability present at the outset in the plant material as well as the same titration (i.e. the concentration of the characteristic chemical class);

 

2. CONTROL OF THE SUPPLY CHAIN:

  • suppliers should be accredited on the basis of rigorous criteria of quality, sustainability and traceability;
  • GAPC guidelines for good agricultural and harvesting practices should be implemented in the supply chain;
  • the need for high quality raw materials should be reconciled with the principles of biodiversity and sustainability indicated by international conventions and standards such as the Convention on Biological Diversity (CBD);
  • the entire supply chain should be under continuous control from cultivation which is constantly monitored by agronomists and botanists, up to the delivery of the raw material to the production sites;

 

3. QUALITY OF THE MANUFACTURING PROCESSES:

  • technologically advanced and safe production plants for both raw materials and operators;
  • processes compliant with production standards and regulations such as Good Manufacturing Practices (GMP) and the Hazard Analysis Critical Control Points manual (HACCP);
  • use of high-quality, precisely defined excipients to optimize the effectiveness of the active ingredient;
  • meticulous inspection of the finished product.

 

Eye Pharma utilizes only raw materials with proven high quality, safety, and efficacy.

Our innovative products are continuously improved and tested in clinical trials with the goal of targeting human health and well-being.

 

2020-04-15T17:24:27+02:00
Le informazioni, immagini, descrizioni e quanto altro riportato nel sito relativi a dispositivi medici non sono di natura pubblicitaria ma materiale informativo rivolto esclusivamente a Professionisti dell’area sanitaria. Pertanto proseguendo nella navigazione l’utente dichiara di essere un Professionista dell’area sanitaria. Riferimento:Ministero della Salute – “Nuove linee guida della pubblicità sanitaria concernente i dispositivi medici, dispositivi medico-diagnostici in vitro e presidi medico-chirurgici” del 28 Marzo 2013; Aggiornamento delle “Linee guida in merito all’utilizzo di nuovi mezzi di diffusione della pubblicità sanitaria” del 17 Febbraio 2010 - These statements have not been evaluated by the Food & Drug Administration. These products are not intended to diagnose, treat, cure or prevent any disease. Please contact your healthcare professional immediately if you experience any unwanted side effects. The information contained herein is for informational purposes only and does not establish a doctor-patient relationship. Please be sure to consult your physician before taking this or any other product. Statements regarding dietary supplements have not been evaluated by the FDA and are not intended to diagnose, treat, cure, or prevent any disease or health condition.
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