Since the introduction of the EU GDP guidelines (2013/C 343/01) in 2013 and the inclusion of transport and export within the scope of the guidelines and regulations, transport providers can have difficulty in achieving compliance with regulatory requirements.
Experience gained from many years as a Regulator has revealed the types of issues that repeatedly occur when planning and undertaking transportation activities.
Many of the failures to comply with Regulations can be avoided by appropriate planning, risk assessment, supporting quality systems, careful outsourcing and staff training.
It should be remembered that all medicinal products that state storage requirements on the label are temperature sensitive, not just refrigerated products.
Transportation is a big area and one that demands a great deal of planning and forethought.
With so much complexity in the supply chain below are some highlighted areas that reoccur as regulatory deficiencies and further guidance on how to avoid them will be discussed during the training event.
These will include:
- Risk Assessments
- Modes of transport
- Loading/unloading/cross docking
- Self Inspections
- Outsourcing and review
- Driver Training
- Regulatory Action and Sanctions
- Role of the Responsible/Designated Person and their responsibilities
A more in-depth review of the guidance and training on areas of EU GDP and their application in areas of transport will be discussed with practical examples and interactive learning during a training seminar Temperature Controlled Logistics in Pharma & Biotech being organised by Fleming on the 3 & 4 June 2020 in Amsterdam.