GDP in Pharmaceutical Distribution

Tim Ohlrich, Manager GMP Compliance Projects and GDP expert at gempex, contributes to the seminar with the topic "Qualification of service providers in transport". Mr. Ohlrich presents opportunities for the qualification of logistics service providers, explains the validation of transportation routes and gives an overview of the complete distribution chain, the so-called "Quality Oversight".

In addition, the seminar will highlight other topics and concerns such as

  • Requirements for distributors and wholesalers
  • The role as a responsible person for GDP and their delimitation of responsibilities
  • Explanation of the risk-based approach and risk management for GDP in pharmaceutical distribution
  • Evaluation of deviations
  • Transport validation


By dealing intensively with these topics, many uncertainties are covered that may occur during the implementation of GDP requirements - caused by the high level of detail of the EU GDP Guideline. This GDP Guideline applies mainly to manufacturers and wholesalers, but must also be taken into account by storage, transport and distribution companies.
For all participants in the distribution chain, questions may therefore arise such as

  • Does the transport represent an extended storage time?
  • How are the transport conditions checked?
  • Do personnel have to receive regular training, and what are the topics of such training?
  • How are deviations handled?
  • How helpful is the risk-based approach really?
  • Who is responsible in the event of damage?
  • How do the Incoterms (International Commercial Terms) touch the GDP requirements?

 

At the end of the two-day seminar, Tim Ohlrich will be answering participants' questions when it comes to dealing with details in the implementation. Furthermore, he will provide pragmatic solution approaches to any potential challenges. For example:

  • Findings from GDP authority inspections in pharmaceutical trading and proposals for dealing with the same
  • Whether temperature measurement is required for each shipment
  • How to define the transport conditions and the best way 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 receiving and returns traffic


For further questions on GDP in pharmaceutical distribution and on all other GDP-relevant topics, please contact Tim Ohlrich at:  contact@gempex.com
Information about Concept's GDP seminars can be found on the  organizer's website.