Compliance with Good Distribution Practice (GDP)

We help you find adequate and cost efficient solutions for achieving GDP compliance by 

  • identifying the key risk factors for your products
  • analysing the impact of temperature changes on product quality, performing kinetic modelling in case experimental stability results are not available. 
  • defining appropriate temperature conditions during storage and transport
  • choosing qualified logistic partners and
  • analysing the financial impact

 

We also provide the services of a GDP Responsible Person or German Großhandelsbeauftragter (§52a AMG). 

 

Guideline on Good Distribution Practice (GDP)

In 2013, quality assurance requirements concerning the distribution of medicinal products were increased significantly with implementation of the revised EU Guideline on Good Distribution Practice. In times of tight budgets, wholesalers and manufacturers are challenged to introduce additional measures while keeping costs at a minimum.