Quality

The Department of Quality is in charge of continual improvement of the quality management system, as one of the aims of PHOENIX Farmacija quality policy.

Compliance of business operations with the GMP requirements for the wholesale of drugs and European GDP guidelines is continually monitored, and the results PHOENIX Farmacija achieves are always outstanding. Quality management is carried out by monitoring implementation and continually improving internal standard operative procedures (SOPs). These procedures cover checking, receiving and handling products, distribution and transport, maintaining warehouses, educating employees, internal audits, receiving, storing and distributing products for clinical research, instructions for emergency situations, such as cold chamber malfunction, recalling products etc. Standard operative procedures are aligned with valid European GDP guidelines, the requirements of European GMP and national regulations. Operations of both the consignment and other warehouses of PHOENIX Farmacija are regularly audited by our principals, receiving always the highest of grades.
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Licences and certificates

  • GMP certificates
  • Manifacturing licence
  • Wholesale distribution authorisation
  • GDP Certificate
  • Management system certification

Licences granted to business centres are available at the following links:

All licences and certificates are available through Eudra GMDP base.

Licences granted to business centres are available at the following links:

Manufacturing licence and Good Manufacturing Practice

For the purpose of packaging PHOENIX Farmacija has cooperated with experts in the area of Good Manufacturing Practice and has reconstructed the 254 m2 of the warehouse in Velika Gorica Centre, in accordance with the requirements for secondary drug packaging, with a cold chamber for the packaging of thermally unstable products, the so-called cold chain.

The quality system and manufacturing facilities have met the criteria of the Agency for Medicinal Products and Medical Devices inspections, and PHOENIX Farmacija has been issued a manufacturing licence which enables the following:

Contractual drug packaging and drug batches release and certification
Packaging tested drugs according to clients’ demands
Physical place of import of drugs coming from third countries and release on the market for marketing authorisation holders in the EU territory
A possibility of packaging different forms of drugs (sterile, non-sterile and biological drugs) with different storing conditions (cold chain, ambient conditions)
Interventional importation of drugs (without marketing authorisation in Croatia) from third countries

Contact person

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Andrijana Mojzeš

Quality Manager

+385 1 3650 156
A.Mojzes@phoenix-farmacija.hr

Useful links