GDP in Pharmaceutical Distribution

GDP in Pharmaceutical Distribution | Live Online Seminar | March 23/24, 2022

As an expert in GDP, Tim Ohlrich, Manager GMP-Compliance Projects at gempex, supports the seminar GDP in pharmaceutical distribution on March 23/24, 2022 with his know-how on the topic "Qualification of service providers in transportation" as well as in interactive workshops, in which the specific questions of the participants will be discussed. Possibilities for the qualification of transportation service providers will be presented, the validation of transportation routes will be explained and an overview of the complete distribution chain will be given, the so-called "Quality Oversight".

The high level of detail of the EU GDP guideline applies primarily to manufacturers and wholesalers, but must also be considered by warehousing, transportation and distribution companies and leaves some of those responsible frowning. However, many uncertainties that may arise during the implementation of GDP requirements can be eliminated by intensively dealing with these topics.

Questions that may occur to all parties within the distribution chain regarding the EU GDP Guideline include among others

  • How do the new rules for veterinary medicines affect the processes?
  • Does the transportation represent an extended storage time?
  • How are the transportation conditions controlled?
  • Do staff need to be trained regularly, and what are the topics of such trainings?
  • How are deviations handled?
  • How helpful is the risk-based approach really?
  • Who is liable in case of damage?
  • How do the Incoterms (International Commercial Terms) affect the GDP requirements?

At the end of the two-day seminar, participants will not only be able to answer many of these questions themselves, but will also have the opportunity to address open questions to the speakers. Many pragmatic approaches for solving potential challenges will certainly be provided, for example

Proposals for dealing with GDP authority inspections in pharmaceutical trade

  • Whether temperature measurement is required for each shipment
  • How to define the transport conditions and how best to comply with them
  • How much training is required
  • Possibilities for training foreign language service providers
  • From when a hub is a warehouse (intermediate storage in transshipment points)
  • How separation of blocked and returned goods storage should be handled
  • Tips on returns acceptance and returns traffic

The learning content of this live online seminar from Concept Heidelberg is shortly summarized in:

  • Requirements and expectations
  • Responsibilities and responsibility delimitation
  • Liability
  • Problems, challenges and possible solutions
    • Qualification of transportation
    • Risk analysis
    • Evaluation of deviations
    • The "last mile"

For further questions on GDP in pharmaceutical distribution and all other topics regarding GDP, please contact Tim Ohlrich at  info@gempex.com.
The complete program of the seminar "GDP in pharmaceutical distribution" can be found  here (German language).