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The EU GDP Guideline 2013/C343/01 has been adopted into law in Switzerland effective July 2015

24.Sep.2015

The Federal Department of Home Affairs has adapted the Guidelines on Good Distribution Practice of Medicinal Products according to EU law. This move increases quality requirements for the distribution of medicinal products and strengthens patient protection. At the same time it prevents any trade obstacles for Switzerland vis-à-vis the EU.

By amending Appendix 2 of the Medicinal Products Licensing Ordinance (MPLO), Switzerland adopts the new GDP Guideline 2013/C343/01 and aligns Swiss requirements with the stricter EU regulations. A six-month implementation period is projected: Good Distribution Practice of Medicinal Products (GDP Guidelines)

As an operator of ELPRO's Central Monitoring System (CMS) we would like to draw your special attention to article 3.2.1 «temperature- and environmental monitoring» of the GDP guideline 2013/C343/01, what describes that the sensors should be located according to the results of the mapping exercise, ensuring that monitoring devices are positioned in the areas that experience the extremes of fluctuations. This means that you need to identify the hot and cold spots in your warehouses and equip at least these spots with a CMS sensor. If you have any detailed queries please do not hesitate to contact us. The ELPRO specialists are pleased to provide their entire support or advice regarding Thermal Mapping, replacements of sensors, requests concerning the GDP guideline 2013/C343/01 or on any other inquiry. ELPRO is your trusted partner to help you implement the new guideline within the required period and will assist you to meet the MPLO on the following points:

  • Quality risk analysis and management in accordance to ICH Q9 (chapter 1.5)
  • Temperature distribution studies in warehouses (Thermal Mapping, chapter 3.2.1)
  • Qualification and validation (chapter 3.3.2)
  • Risk assessment of transport routes to identify the necessity of a temperature control (chapter 9.2)
  • Temperature distribution studies of vehicles (chapter 9.4)

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