Clinical Site Pharmacy

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The company  pays a big attention  to the adequate supervision of  investigational  products.

Investigational products are stored in Clinical Site’s Pharmacy. One of Pharmacy’s main parts is a registered sterile laboratory designed for cytotoxic drug preparation. The level of microbiological cleanliness (level B) of this laboratory is monitored regularly. The laboratory  is equipped with an intake-exhaust ventilation (with HEPA filters) and a laminar flow cabinet.

• The product flow is supervised by the experienced pharmacist. A special attention is paid to the following issues:
• The flow of a delivered product is monitored from the moment of receipt until it is returned to the Sponsor (formal documentation defined in the Site procedures)
• Investigational products are stored in rooms, where the temperature and humidity are controlled and monitored (the range from +4 to room temperatures). Relevant data is electronically recorded and printed monthly.
• Access to the place of product storage is limited and  monitored.
• Labels are prepared in compliance with GMP requirements concerning medicinal products.
• Professional randomisation of medicinal products.