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IMP Depot

PharmaSich exclusively contracted a local Acinus IMP Depot in Ukraine in 2015 for the purpose of clinical trials and started providing all clinical logistic services including IMP import/export, local procurement of clinical supplies, storage, distribution and destruction.

The Depot of the “Acinus” company is our strategic partner in Ukraine. It has quite a long history of work in local pharma market starting from 1996 when it was created to manage logistic needs of a private medical clinic. As the clinic grew the need for more contemporary storage facilities increased and a pharmaceutical warehouse emerged as a separate business branch.

PharmaSich has reserved storage areas in the facility and is prioritized by the Acinus as a strategic partner in terms of providing resources for PharmaSich projects.

PharmaSich is exclusively authorized to present this depot to Sponsors and CRO customers and performs management of clinical projects at the facility.

With company’s business diversification, the warehouse was re-arranged on several occasions, last in 2007. Now it’s a large dedicated three-storey facility built from scratch to adopt advanced technologies and follow current GMP/GDP regulations. It embodies several construction decisions and infrastructure engineering solutions that the company is proud of and readily shares with guests during inspections. The building has autonomic heating system, natural and assisted ventilation system, fire alarm, centralized water supply, walk-in refrigerators for -2 – 8°C and +8 – 15°C storage, freezers, sophisticated temperature monitoring system and other features. The setting is under constant security surveillance.

The storage has separate zones for various types of operational preparations. All premises are dry, protected from direct sunlight, rain or subterranean waters, have fireproof walls, supply and exhaust ventilation, and are equipped with air conditioning system for maintenance of required temperatures. Air humidity is under constant control with psychometric hygrometers. All racks, shelves and pallets are fireproof. There are three refrigerating rooms and special rooms with limited access for storage of narcotic drugs, psychotropic substances, precursors and other controlled substances. Wiring and lighting fittings are fire and explosion-proof. Premises have burglar and fire alarms.

The organizational structure of the depot comprises three departments: department of receipts (including area for quarantined medicines), operational department and department for orders assembling and expedition.

All operations in the depot are standardized according to the requirements of the GDP and local regulations:

  • Standard/guidance by Ministry of Health (MoH) of Ukraine 42-5.1: 2011 “Drugs. Proper storage practices”;
  • Standard/guidance by MoH of Ukraine 42-5.0: 2014 “Drugs. Good practice of distribution.”

These documents are the result of harmonization of Ukrainian legislation with European regulations and particularly Guidelines on Good Distribution Practice (GDP) of Medicinal Products for Human Use (94/C63/03) which establish principles and requirements developed according to European Council Directive 92/25/EEC of 31 March 1992.

These national guidelines are also in line with the requirements of ISO and State Standards of Ukraine (DSTU):

  • DSTU ISO 9000-2001 “Quality Management System. Main provisions and glossary”,
  • DSTU ISO 9001-2001 “Quality Management System. Requirements”,
  • DSTU ISO 9004-2001 “Quality Management. Guidelines for improving performance” and
  • Standard/guidance 42-4.11:2008 by MoH of Ukraine “Drugs. Good manufacturing practice”.

Based on the aforementioned local regulations, the warehouse has developed, implemented and is currently following Standard Operating Procedures (SOPs) in every stage of drug relocation: from drug acquisition/receipt to its dispensing/checking out. Among others, the following procedures are in place:

  • SOP on document flow;
  • Drug receipt and check-in control SOP;
  • Dispatch of Clinical Supplies SOP
  • Drug quality control SOP;
  • Drug storage and relocation SOP;
  • Storage facilities preparation SOP;
  • SOP on insects and rodents control;
  • SOP for return and recall of medicinal products and medical devices.
  • Re-labelling procedure
  • Cold Chain procedure

The warehouse is operated by qualified staff including pharmacists and managers with Pharmaceutical/Clinical Research backgrounds and skilled assisting work force.

IMP destruction is done through the contracted licensed destruction vendor.

PharmaSich also has certified customs brokers to perform import and export of clinical supplies.

Since its engagement in investigational trials a warehouse has been adapted to provide study-related services and host storage facilities for investigational products and medical devices. Now it’s a fully functional Depot capable of providing all operations you may need during your study project in Ukraine. There’s a dedicated manager exclusively dealing with PharmaSich projects. You can order depot service in Ukraine from us.

 

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