Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts Our depots have imlemented best practices of clinical trials logistics in compliance with GCP, GDP,GSP and GMP standarts

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IMP & CTS Management

IMP & CTS Management (Depots in Ukraine, Georgia and Russia )

Sanaclis was the first CRO with the warehouse in Ukraine specialised on IMP management for international clinical studies (since 2001). Even today we are the only CRO in Ukraine with its own warehouse (1060 m²) and up-to-date technologies (ELPRO central monitoring system, CTMS, CCTV).

Our depots in Ukraine and Russia have implemented best practices of clinical trials logistics in compliance with GCP, GDP and GMP standards.

Experience:

  • SanaClis has done over 38 000 shipments to sites (2001-2013; ambient, cold, frozen)
  • successfully passed 41 GCP / GMP sponsor audits and 7 GMP / GCP inspections

SanaClis Ukraine warehouse : GMP/GCP audits

No critical findings in 48 audits / inspections

Services

  • storage of IMP & CTS (ambient, cold, frozen, toxic)
  • distribution (own insulated vehicles, couriers trained in GDP; TNT)
  • local purchase and labeling of comparators / rescue medication
  • validated packaging configurations ( ambient: LM Medisorb 4/20/40/95; cold: Credo 1447, LM Chilterm)
  • certified temperature loggers for t-controlled ambient and cold/frozen shipments ( ELPRO loggers m/u; Sensitech TT4 m/u )
  • local incineration, destruction certificates
  • archiving

Any shipment to site can be done only upon prior agreement with the authorized investigator (investigator confirms his/her presence at site to accept the shipment).

Warehouse in Ukraine


Warehouse is located between Kiev airport and Kiev city (yellow pin).The warehouse obtained pharmaceutical licence in 2012.

  • Total Usage Area: 2500 m2
  • Total Warehouse Area: 1060 m2
  • Strictly Limited Access: 801 m2
  • Cold Rooms / Cold Storage: 81 m2
  • Ambient storage: 720 m2

IT Technologies

SIMS - SanaClis Inventory Management System, a GxP compliant software system. It is used to barcode incoming products and to keep track of all operations. The system has built-in data validation mechanisms/operational checks (such as storage conditions checks, expiry dates checks, etc.) to ensure correctness of data/operations. The system keeps all the records in a reliable database, protected by remote backups. The system also features direct B2B links with the IxR systems of our clients, updating the relevant data in automatic mode without human intervention/errors.

ELPRO Central Monitoring System - Swiss made validated monitoring system for controlling temperature/humidity. Provides reliable, around-the-clock monitoring with local audio-visual alarm and automatic remote messaging. Data protection/security is ensured by industrial strength encryption removing any possibility of data alternation. This extremely reliable and regularly calibrated system is compliant with FDA, GxP and GAMP requirements.

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