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New EU GDP Guidelines of 07.03.2013 – Update 08.09.2013

The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013 and will apply across the European Union as of 8 September 2013. With the project “GDP-Readiness” Medizone checked all SOP’s and procedures to ensure full compliance to the new Version of the Guidelines. These are only some of the action items we performed in the last six months:

  • All of our established and proven transport partners were re-qualified and Quality Agreements have been established, where they did not exist in the past.
  • The preparation for more stringent rules on transport and temperature monitoring during transport has been finalized and implemented.
  • The Cold-Chain-Procedures have been expanded to cover Controlled-Room-Temperature, too. SOP “Cold Chain” got “Thermo-Sensitive Pharmaceuticals”
  • All SOP’s have been reviewed to ensure full compliance to the new Version of the Guidelines.
  • CAPA-procedures – as we still did in the past – have been described in the new SOP “CAPA (Corrective And Preventive Action)”
  • Master Data Procedures – that we still handled according to the four-eye-principle in the past – have been described in the new SOP “Master Data”.

To be continued… With our procedures we try to get even better day by day to

provide better service to our clients.