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Quality Control

Santonika's plant is based on the Good Manufacturing Practice (GMP) – high-quality assurance standards that guarantee consistency in developing, manufacturing, investigating preparations so that they would correspond to their purpose, the requirements of the marketing authorization certificate and of the specifications.

Santonika's quality system is adapted to the requirements of national pharmaceutical legislation and complies with applicable EU regulations governing the production of pharmaceutical products. Quality and safety of our production is confirmed by GMP certificates and we make every effort to ensure constant quality and maintenance of GMP standards in our plants

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Quality management functions
are performed:
Quality Assurance Department
Responsible for creating, developing, coordinating and managing the entirety of issues related to Santonika's pharmaceutical quality system. Quality control is an integral part of our quality system.
Quality control department
Operates laboratory facilities where physicochemical, microbiological and biological tests are performed. The laboratories of the quality control department meet EU standards in the scope of performing analysis, validation of analytical methods and quality certification.
Multicentre double-blind randomized placebo-controlled study “The Efficacy and Safety of Brillia for children in patients with attention deficit hyperactivity disorder (ADHD)”
Brillia for Сhildren significantly decreased the ADHD symptoms (by more than 50%) in 32% of patients with AHDH after 12 weeks of product use (assessed with ADHDRS-IV-Home Version scale)

*p<0.05 compared to placebo

#p<0.001 compared to baseline
Brillia for children has been found to improve attention by 31.7% after 12 weeks of product use (assessed with ADHDRS-IV-Home Version scale).

*p<0.01 compared to placebo
Brillia for children reduced ADHD symptoms severity by 36% after 12 weeks of product use (assessed with ADHDRS-IV-Home Version scale).
Multicentre double-blind randomized placebo-controlled study
“The efficacy and safety of Brillia for children
in patients with anxiety disorder”
Brillia for Children has been found to reduce anxiety symptoms up to 22% after 12 weeks of product use (assessed with the anxiety test of R. Temmpl, M. Dorki, V. Amen).