Good Distribution Practice of active substances for human and veterinary medicinal products
22. Oktober 2026
Course No. 22242
Speakers
Dr. Marcel Günther
Regierungspräsidium Tübingen
Dr Ulrich Kissel
European QP Association (EQPA), KisselPharmaConsulting
Dr Martin Melzer
Gempex
Target Group
API manufacturers
API distributors and traders
Pharmaceutical manufacturers
Wholesalers
Transport service providers
External warehouses
further service providers offering services for the distribution of APIs
Objectives
Good Distribution Practice (GDP) is the part of quality assurance that ensures their quality is preserved throughout every stage of the supply chain. Consequently, all partners involved in distribution must comply with GDP principles.
However, GDP is not limited to medicinal products. It begins earlier – namely with the transport of active pharmaceutical ingredients (APIs) used for manufacturing. A number of guidelines and supplementary documents provide requirements on the distribution of active substances, which must be implemented accordingly.
This Live Online Training offers a comprehensive overview of the current GDP requirements for active substances for human and veterinary medicinal products. It also highlights how these regulatory expectations can be effectively translated into practice from different professional perspectives.
Programme
Regulatory Requirements related to GDP for Active Substances
Regulations and guidelines
Existing requirements
Regulatory oversight of GDP in practice
GDP-Compliant Transport of Active Substances (Human and Veterinary)
Practical implementation of requirements
Requirements for temperature monitoring and vehicles
Use of transport service providers
Requirements for traceability
GDP-Compliant Storage of Active Substances (Human and Veterinary)
Practical implementation of requirements
Requirements for temperature monitoring
Requirements for inventory/ERP systems
Requirements for quality risk management
Regulatory Inspections and Typical Inspection Findings
Procedure of regulatory inspections
Scope, focus areas and inspection reports
Classification and handling of deficiencies
Frequent and typical deficiencies in warehousing, logistics and transport
Monitoring of Suppliers and the Supply Chain from the Perspective of the Qualified Person
Requirements for supplier qualification
Global supply chains
Importation
Certification
Supply chain documentation
Further Information
Technical Requirements We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT) Non-ECA Members EUR 1,290.- ECA Members EUR 1,090.- APIC Members EUR 1,190.- EU GMP Inspectorates EUR 645.- The fee is payable in advance after receipt of invoice.
Presentations/Certificate The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
