As a GDP compliant component, the logistics solution supports pharmaceutical distributors and logistics providers in the fulfillment and documentation of their certified logistics (transport) processes.
GDP "Good Distribution Practice of medical products for human use" covers the guidelines of the EU Commission that have been in force since 2013 and apply to pharmaceutical retailers and logistics companies. Among other things, they ensure that forged drugs do not enter legal supply chains and help to control the distribution chain to maintain the quality and integrity of pharmaceutical products. The transport of sensitive high value products in particular bears risks in terms of integrity, quality and theft. Furthermore, GDP certified logistics providers are subjected to the strictest protection requirements in the industry. In particular, but not only, the monitoring of temperature-controlled transports creates an extreme logistical challenge. Pharmaceutical companies are therefore obliged to consider these risks and general processes already during the planning of the transport and to monitor and document them along the entire supply chain.
GDP during transport with NIC-place
The use of NIC-place is predestined for exactly these use cases. As a software solution that intelligently combines and analyzes planning information from transport management systems and multiple live data on the basis of telematics systems, NIC-place offers all the necessary capabilities for monitoring, executing and documenting the quality and safety criteria of GDP compliant transports. The comprehensive integrated alarm management at transport level monitors temperatures, positions and door openings and identifies deviations from the target during the tour. The automated escalation of deviations to responsible persons allows immediate countermeasures (CAPA) or even the removal of no longer permitted products from the distribution process. Manual validation processes are no longer necessary, "management by exception" is possible and is supplemented by sophisticated escalation management features that serve to document the actions taken. The knowledge of loading and unloading addresses as well as loaded products means that transports can also be tracked with batch accuracy and seamlessly documented automatically in order to meet the extensive GDP requirements in the follow-up.
GDP compliance of the NIC-place solution
In order to fully satisfy the EU guidelines, pharmaceutical distributors and logistics companies are obliged to use only systems whose desired results can be achieved accurately, continuously and reproducibly. NIC-place is already holistically prepared for this. All relevant organizational measures are taken and documented in such a manner that the scope of services is allowed within the scope of a GDP certification. Due to already completed customer certifications full elaborated audit documents are available. These contain, among other things, detailed descriptions of the solution with regard to basics, objectives, security measures, the coverage area as well as the most important functionalities, handling and integration into other systems. The existing documentation can be expanded to meet the needs of other customers and expanded to include individual project services. This allows a short-term implementation of the certification and ensures that NIC-place can be easily implemented by GDP regulated pharmaceutical customers.
Logistics companies specialized in the transport of pharmaceutical products have been relying on NIC-place solutions for years. NIC-place is market leader in the field of temperature-controlled and high value transports, known for its deep and solid telematics knowledge and offers software solutions for the transport and logistics industry, which are holistically adapted to the current requirements for visibility in transport.