DESCRIPTION OF ACTIVITIES

According to outstanding laws and regulations (Law on Medicines, Pharmacy Act, Regulation on Medicine and Medical Products Distribution), Galen products which are produced in the Galen laboratory are subject to quality control. Uncontrolled medicine is potentially of low quality and represents a risk for the health of the patient. Risks in the medicine production and/or Galen products are:

• unexpected contamination of product which can cause detrimental effect to the health of the user,
• excess or deficit of active ingredients which cause no effect or side effects,
• mislabeling of the product which causes distribution of the wrong medicine.

Therefore, with the intent of patient health protection, the following analyses are conducted:

• all starting medicinal or auxiliary substances used in Galen product or magisterial products production in Galen laboratory and pharmacies
• all intermediate products, semi-products and finished pharmaceutical product in Galen laboratory (Galen medical products, auxiliary medical products, nutritional supplements, fitness products, cosmetics and special purpose cosmetics)

Our common goal is to set a system of quality with Good production and laboratory practice application and develop and put on the marker quality, safe and effective products.

With that goal in mind, the Quality control laboratory:

• samples and preservers reference samples of medicinal and auxiliary feedstock and final pharmaceutical products
• controls the quality of medicinal or auxiliary starting feedstock qualitatively (identification) and quantitatively (degrees of purity and active matter content)
• conducts pharmaceutical – non-clinical trials i.e. analyses active medical ingredients concentration and auxiliary matter content – supplements, as well as the content of degradation products or impurities produced during production and/or safekeeping with the intent of semi-product quality control, finished Galen products, fitness products and cosmetic products
• controls sterility and/or microbiological suitability of feedstock and final pharmaceutical products
• controls Galen product stability, fitness products and cosmetic products and determines expiration dates
• makes reagent sets for starting pharmaceutical substance identification in pharmacies
• participates in development and improvement of Galen laboratory products
• prepares and introduces new analytical methods
• prepares instructions for the analytic procedures and validates analytic methods
• organizes the conduction of a part of the Master of Pharmacy and pharmaceutical technician internship program
• organizes the conduction of a part of specialization in the area of pharmaceutical technology and medicine control and examination
• cooperates with expert, educational and scientific institutions
• conducts researches in the field of pharmaceutical analytics, with the intent of expanding the scope of business of the Laboratory.

EQUIPMENT

For the purposes of pharmaceutical – non-clinical examinations of feedstock and products, the following is applied:

• classical chemical methods (gravimetry, titrimetry, volumetry)
• instrumental physical methods (densitometry, conductometry, polarimetry, potentiometry, refractomery, UV-VIS spectophotometry, paper and thin layer chromatography and liquid chromatography of high efficiency – HPLC with DAD and RI detector)

Methods prescribed in Pharmacopoeias are conducted (Croatian HRF, European Ph.Eur., Yugoslav Ph.Jug, British BP, American USP/NF, Japanese JP, international Int.Ph…)