Welcome to The Cold Supply Chain Services Page

Managing Temperature-Controlled Supply Chain

Pharmaceutical manufacturers must ensure the safety, efficacy and quality of products remain stable for use by the consumer. Ensuring the quality and safety of products may require special types of transportation.  One form of transportation is temperature-controlled transportation.  A cold supply chain is a temperature-controlled supply chain.  When products are transported by Cold Supply Chains, products are at higher risk and the supply chain process becomes more challenging than products that travel the typical supply chain route.

 Products that are required to travel cold supply chains are vulnerable to temperature changes in its surroundings and are therefore time sensitive. These temperature changes are called temperature excursions.

 

Temperature excursions are temperatures that deviate from specified values.  It is not unusual for temperature excursions to occur through temperature-dependent supply chains. Cold chain products can be vulnerable to temperature difference of a few degrees during transportation, which can not only affect the product, but can cause a loss in revenue and could possibly affect patient health.   These temperature events can occur during the transportation, storage, retrieval, loading and unloading of product. When temperature excursions occur, it is the manufacturer’s responsibility to take adequate steps in understanding the location, how the excursion occurred, it's effect on the product, and containing the issue while taking action to eliminate reoccurrence.

 

Quality as you see it has experience in monitoring and managing cold supply chain transportation processes, while implementing solutions to resolve issues that occur throughout the process. 

Cold Chain Management

The two major risks in pharmaceutical cold supply chains are the risk of product becoming adulterated during transport and the risk of non-compliance with federal regulations. Government regulations impacts most every supply chain and can have a significant impact on your organization. Quality as you see it has the knowledge and can provide the support and guidance on regulations that impact cold supply chains.   

Cold Chain Compliance

Quality as you can actively support your compliance efforts towards given standard operation of procedures; providing clear and concise information on shipment requirements, the reporting of product issues downstream to vendors and service providers, and employee training during the planning for material shipments. 

Cold Chain Compliance Support

Quality as you see can support your business in managing and monitoring product through the receiving and inspection of incoming shipments of materials and equipment following established procedures. 

Assist with investigation and process related corrective actions and actively contribute to continuous improvement activities. Updates area standard operating procedures (SOP’s) as required.

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