Peter Kralinger, Carrymed Pharma & Transport, Austria
Kane Edgeworth, Biomap, UK
This Live Online Training aims to give participants a comprehen-sive yet compact overview of expectations concerning the transportation of products requiring special conditions. The focus will be on the requirements for the transport of COVID-19 vaccines and other temperature-sensitive products.
General aspects of road transport and air fright at cold chain (2 – 8 °C) and at ultra-frozen (-70 °C) conditions will be discussed. Furthermore, vehicle qualification and the effective mapping of vehicles will be covered. A Q&A session ensures interaction and that all questions are answered.
It is of key importance that medicinal products are not only made to a high quality in accordance with Good Manufacturing Practice (GMP), but that the quality and integrity of these products are maintained through the entire supply chain to the patient. This is where Good Distribution Practice (GDP) comes into play.
The distribution of temperature-sensitive pharmaceuticals is extremely challenging. The EU GDP-Guidelines (Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use) require that if temperature-controlled vehicles are used, the temperature monitoring equipment used during transport should be maintained and calibrated at regular intervals. Temperature mapping under representative conditions should be carried out, taking into account seasonal variations. For temperature-sensitive products, qualified equipment (e.g. thermal packaging, temperature-controlled containers or temperature controlled vehicles) should be used to ensure correct transport conditions.
With the approvals of various COVID-19 vaccines in many countries, the question arises how to safely transport the serum from manufacturing facilities to storage and distribution centres, and then onwards to local healthcare facilities and vaccination centres. However, this question does not only arise for COVID-19 vaccines, but also for all temperature-sensitive products in general.
The specific packaging, transport, handling and storage requirements of the various COVID-19 vaccines are partly still open. The transport routes may also depend on the future production sites. In any case, transport companies must take special safety precautions for the transport of COVID-19 vaccines. The serum is not only very valuable, but also particularly sensitive. Damages can quickly lead to a total loss, as in case of doubt, the entire load must be destroyed. In addition, there are risks such as interruption of the cold chain. Therefore, the vaccine may only be distributed with controlled packaging solutions and in special vehicles that are appropriately qualified and whose temperature is monitored permanently
This Live Online Training was developed for managers, executives, Responsible Persons (RP’s), technical staff and other employees from companies involved in the distribution and supply of COVID-19 vaccines and temperature-sensitive pharmaceutical products.
It will be of interest in particular for personnel from the following departments:
- Quality Assurance
- Cold Chain
- Regulatory Compliance
For our Live Online Training Courses and Webinars, we use Cisco WebEx, one of the leading suppliers of online meetings. At http://www.webex.com/test-meeting.html you can check if your system meets the necessary requirements for the participation at a WebEx meeting and at the same time install the necessary plug-in. Please just enter your name and e-mail address for the test. If the installation is not possible because of your rights for the computer system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Welcome and Introduction
(Dr Markus Funk)
Temperature-Controlled Transports of Medicinal Products
- Insulated packaging for small and large quantities
- Road transport and air freight of cold chain products (2 – 8 °C)
- Transport and storage at ultra-frozen range (-70 °C)
- Qualification of temperature-controlled vehicles (IQ/OQ/PQ)
- Regulatory landscape
- Matrix approach for larger fleets
- Vehicle mapping case study
Questions and Answers Session
(Peter Kralinger and Kane Edgeworth)
- Participants are invited to ask questions