The EU requirements around handling medicinal products that require controlled temperature storage are clear, but they do not specify how to achieve the stated standards.

To prepare the supply chain, temperature mapping of the warehouses and the distribution network is not a complicated task, but does require knowledge and expertise in the various options available. The actual work requires significant resource and is time consuming. If your primary concern is protecting your products and the patient, controlling the risk of product spoilage and maintaining your market share, you need a qualified supply chain in line with the regulatory expectations.

With this in mind, Biomap has formed a strategic alliance with one if the industries most experienced GMP consultancies, Tabriz Consulting Ltd to offer the bespoke compliance service, 3CS Cold Chain Compliance. The service is completely flexible but typically involves a detailed supply chain process map and audit, then based upon the gap analysis work, Tabriz Consulting Ltd recommend mitigation plans for each risk and the work that will be involved in working towards GMP compliance.

Projects are valuable to tighten compliance in areas of weakness as well as helping to prepare for license applications or regulatory & QA audits in addition to reducing your excursion rates and gaining control of your supply chain!

We can help you achieve these goals in an efficient and cost effective manner.

Our combined service offers:

Development and implementation of GMP compliant Supply Chain Quality Management System that includes:

• Detailed supply chain audit
• Supply chain process map
• Risk assessment, and risk classification
• Recommended mitigation plans for each risk
• Temperature map of the warehouse to include high risk areas (i.e. areas where temperature could reach the extremes of specification, (too cold or too hot)
• Full report of the mapping exercise
• Recommended locations for ongoing monitoring of the warehouse temperature
• GMP compliant Warehouse temperature qualification report to meet the regulatory expectations
• Development of operating procedures for the warehouse and maintenance of the qualified status of the warehouse
• Qualification of the transportation system, to include storage containers, trailers, vehicle qualification IQ, OQ, PQ (e.g. vans, trailers), route mapping, and qualification report with recommendations on how best to maintain the product temperature in transit with supporting temperature data
• Specific support for ‘Temperate’ products
• Training of staff, on the implemented procedures and systems
• GMP/GDP training for all staff
• Ongoing support after implementation to ensure trouble free operations

Contact us to discuss the service further