EU-GDP Guideline for Medicinal Products for Human Use
Logistics for Pharmaceuticals - Qualification of Transport Service Providers - Good Distribution Practices
Rarely, has there been a topic from the world of Good Distribution Practices that has received as much public attention as the current distribution of COVID-19 vaccines. The reliable implementation of refrigerated, frozen and even ultra-frozen transports is suddenly occupying the media.
From a technical point of view, the task has long been a feasible challenge for many special logistics companies - but in terms of volume, diversity of destinations and means of transport, as well as the tight timeframe available, it represents a completely new dimension in pharmaceutical logistics. Especially for the distribution in the different regions and areas, a variety of local forces is needed to complement the capacities of the special logistics companies.
But are they sufficiently equipped? Could transports be conducted not only along the temperature requirements of the respective vaccine, but overall in line with the requirements of the GDP regulations?
Regardless of whether the company would carry out the transports itself or would like to involve a service provider with the distribution of vaccines or medicines: the quality of the medicinal products has to be absolutely reliable and fully guaranteed!
Which requirements have to be met and for whom? Who must implement them? And who has to ensure implementation? It is not always clear which part of the EU-GDP guideline for medicinal products for human use should be applied to which stakeholder in the supply chain.
In international goods traffic, there is also the question of the extent to which the recently harmonized WHO rules for GDP are to be recognized as equivalent to the EU-GDP Guideline.
The following topics have often dominated projects in GDP consulting practice in recent years - from manifold perspectives:
1. Permission wholesale
How must a QM system be structured in order to obtain a permission for a specific project?
What has to be done to implement the duties of an existing permission permanently and responsibly?
What has to be considered in order to meet new tasks in a GMP-compliant manner and to integrate them successfully into the QM system?
2. Qualification/mapping of warehouses
What requirements have to be placed on a warehouse from the GDP perspective?
How can the risk-based approach be implemented efficiently and in a target-oriented manner?
What needs to be considered in order to lead a qualification to success with appropriate effort and the right requirements?
3. Qualification of vehicles and transport packaging (transport verification)
Which criteria are actually decisive for a product-compliant transport?
Which test scenarios provide reliable insights about a transport?
Which scope of control provides the necessary security and remains practicable?
4. Qualification of transport service providers
What has a transport service provider to master in order to provide the necessary product safety?
How can a transport service provider be integrated efficiently and GDP-compliant into one's own area of responsibility?
What are the factors of successful cooperation in daily business?
A good overview and valuable tips from practice are provided in the technical article by Tim Ohlrich, gempex GmbH, Manager Pharma/ Biotech and specialist expert for GDP issues:
Supplier qualification of transport service providers
Published in: Pharm. Ind. 78, no. 1, 40-44 (2016).
This article takes up exactly the then new and today still valid requirements and gives an overview.
The German-language article is available for download at gempex.com/GMP-Knowledge.
We wish you an informative read.
In case of any questions on this topic, the author will be happy to assist: Tim.Ohlrich@gempex.com