Standardization & Risk Management In Cold Chain

Cold Chain IQ

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Ahead of the 14th Cold Chain - GDP & Temperature Management Logistics Global Forum, Cold Chain IQ looks at the concept of global standardization with risk management in the cold chain. This whitepaper explores supply chain security and validation as they pertain to lane qualification, data monitoring, shipping lanes and stability budgets. 

Supply Chain Security

There are a number of challenges faced when it comes to achieving worldwide standardization of supply chain security within the cold chain. For example, complications are encountered with the level of international regulatory convergence that is required. Brian Johnson, Senior Director Pfizer Supply Chain Security explained: “It’s  manageable to get industry standards in place and get scientists to agree in best practices. [However], getting those best practices  transformed into regulations and legislations around the world and getting standardization between governments and regulators is difficult [as well as] finding standards that are applicable to very different economies around the world.”


With local infrastructures placing such a blockade on creating a global standard, Charles Forsaith, Director, Supply Chain Security, Purdue Pharma LP notes that TAPA’s set of facility security standards with chapters dedicated to different regions represent quite possibly the closest reality to a global standard the industry will see. As TAPA is a voluntary membership organization, the body is unable to impose those standards on companies beyond a certain extent.Common terminology is another roadblock for synchronizing international efforts. Standards and certifications are needed to provide common definitions and improve understanding. 

Which leaves the question: What would the by-products be if the industry dropped the mission to deploy standards for international supply chain security? Experts note that this would result in seeing counterfeit medicines enter the supply chain – placing critical risk on patient safety. Firms would also run the risk of having shipments stolen and being left unaware of when or if the shipment is recovered – another significant risk. These prospects highlight the importance of fully knowing your partners of choice for the cold chain maintenance and security of your shipment.

In maintaining the mission to improve global security standards, membership to trade associations and local initiatives will be key. Charles Forsaith notes that this will allow members to participate in helping achieve

standards and validating supply chain security in various regions.. Brian Johnson encourages all stakeholders to engage in working with regulators, governments and law enforcement bodies to assist with the development of legislation and regulations around the world. He adds that, in the creation of legislation and guidance, regulators should strive to implement a holistic approach, simultaneously considering cool chain, supply chain security and falsified medicines and GDP matters.

This wider view will be instrumental in combatting emerging threats. Packaging professionals are often trained in process and quality improvement programs to narrow focus to a set of key factors that reduce vulnerability. While such focus may be efficient for root cause analysis and refinement of operations, it may be the wrong method to address emerging or evolving threats. The narrowing of focus results in the testing of fewer places, opening more opportunities for counterfeiters to act and not be detected. Having too narrow of a product counterfeiting focus can be inefficient at best  and catastrophic at worst.

Anti-counterfeiting standards and certifications will continue to evolve and provide effective best practices. Efficiently meeting emerging laws and regulations will continue to be important, but they should not be a distraction to existing business risks. Understanding impending regulations and standards are important but there must be a focus on mitigating specific business threats that may already exist. (1) 

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