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New EU GDP Guidelines – Part II

The “Guidelines on Good Distribution Practice of Medicinal Products for Human Use” have been published 07.03.2013. But only a few months later the GDP had to be renewed. The new version 2013/C 343/01 “corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines. It also gives more explanations on the rationale for the revision as well as a date of coming into operation.” (1)

Medizone happily acknowledged, that many of the additional translations errors were corrected by establishing the German translation of 2013/C 343/01.

Unfortunately there again are some new translation mistakes in the German GDP of 05.11.2013, but less than before.
This might be subject to another news coming up soon.

Medizone is up2date and full compliant also to the newest version of the Guidelines. These are some more of the action items we performed and the results, we achieved:

  • 100% of transportation with qualified and audited logistics partners
  • Stringent rules on transport and temperature monitoring during transport work well, proven by self-inspection in February 2014.
  • Risk-Based self-inspection-plan has been implemented.
  • Risk-Based process on temperature control has been established and shows success while testing it in real life.
  • All SOP’s have been again reviewed to ensure full compliance to the newest Version of the Guidelines of November 2013.
  • Description of the computerised systems of Medizone Germany GmbH as requested by GDP 2013/C 343/01 of 05.11.2013 has been finalized.

To be continued…

(1) Introduction Section 3

With our procedures we try to get even better day by day to provide better service to our clients.