Cold Storage Supply Chain

While GDPs have been in place for a while, latest regulatory scrutiny, industry initiatives and products requiring specific thermal conditions demonstrate the need to establish a corporate strategy for the distribution of temperature very sensitive products in accordance with product requirements, regulations and industry standards. The initial focus of cold chain management should be the development and implementation of the cold chain shipment compliance process and the cold chain management processes necessary to meet product and regulatory requirements. Unlike product storage in qualified temperature controlled facilities, product shipping, even in qualified temperature controlled shipping systems, is subject to a greater number of temperature excursions due to transportation process variability.

Consequently, temperature excursions occur during product shipping and although these temperature excursions are usually supported by product stability data, some nations enforce strict conformance with product label claim temperature. The implication of this enforcement, at the very least, is the risk of supply chain interruption due to shipment release delays and\/or shipment rejections due to temperature non conformances. Consequently, the initial focus of cold chain management should be the development and implementation of the cold chain shipment compliance process and the cold chain management processes. While references can be to cold chain, the approach outlined applies to any temperature very sensitive product category.

Cold Chain supply chain - A process for periodic shipment conformance measurement and reporting should be established after appropriate qualification of temperature controlled shipping systems and implementation of post qualification temperature monitoring. Shipment conformance is the basis for evaluating not only the continuous performance of qualified shipping systems, but additionally of the entire shipping lane process. This shipping lane compliance model is based on four root cause categories, which provide for consistency in RCA and CAPA identification and implementation. The cold chain shipment compliance process should be part of the general cold chain management program, which in turn supports supply chain business objectives.

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While improving shipment conformance to an acceptable level requires a structured problem solving approach, it is the development and implementation of processes\/procedures that ensure sustainability. Consequently, the next step in cold chain management should be the development and implementation of the cold chain management processes. Cold Chain Management Processes - The objective of the cold chain management processes is to establish processes to maintain product quality and ensure compliance with the regulations and industry standards for the storage, handling and distribution of temperature very sensitive products. The cold chain management processes can be established with the starting place of Good Manufacturing Practices and Good Distribution Practices. GMPs aren't new, as they've been in effect for several years and are usually well understood.

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