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Risky Business


This year the Food and Drug Administration (FDA) issued a report titled “Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach” (cGMP stands for Current Good Manufacturing Practices). The Medicines and Healthcare products Regulatory Agency (MHRA), the equivalent of the FDA in the United Kingdom, has long adopted a risk-based inspection strategy. A risk corresponds to the possibility that a function, a procedure or a product does not perform as expected. Risk management programs consist of activities and actions to control risks. References on risk management for the healthcare industry are widely available.

The International Conference on Harmonization (ICH) wrote the “quality risk management Q9”, the Pharmaceutical Quality Group (PQC) released a “Guide to Supply Chain Risk Management for the Pharmaceutical and Medical Device Industries and their Suppliers”, while the Parenteral Drug Association (PDA) published “TR 58 Risk Management for Temperature-Controlled Distribution”, to name a few.

When it comes to risks associated with transportation, healthcare shippers need first of all to fully understand regulatory and product-specific requirements, such as shipping mandates and chemical properties and sensitivities of healthcare products. Shippers are responsible for selecting appropriate packaging solutions and assessing transportation providers. Once done, shippers may decide that each and every shipment should be monitored for security and temperature for instance, or rather take a risk-based approach instead and monitor only a small sample of shipments.

Transportation providers are also taking risk-based approaches to maintain integrity of healthcare shipments. Many providers are actually investing in cold chain infrastructure at key transit locations, including airports, for contingency planning of healthcare shipments.

Overall performance on major pharmaceuticals transportation lanes from India to the United States is, for instance, being reviewed regularly at FedEx Express by looking at key metrics such as aircraft temperature compliance. If data shows that temperatures did not fall within expected temperature ranges for specific cargo compartments and shipping solutions, then training and communication are reinforced while necessary corrective actions are being implemented in a timely and thorough manner.

As a Technical Fellow for FedEx Express, my main focus is to provide subject matter expertise on cold chain transportation in general, with a focus on risk management in particular.

Risk management methods used in the healthcare industry and referenced above are applied to create internal documents and protocols for specific products and services offered to healthcare shippers. The robust document drafted recently around the FedEx thermal blanket solution includes a comprehensive listing of the relevant materials and procedures before dealing with specifics of risk assessment.

Operational parameters were identified in a team brainstorming exercise within the Life Sciences and Specialty Services (LS3) unit of FedEx Express and placed on a Ishikawa or fishbone diagram around six categories. Failure Mode and Effects Analysis (FMEA) method listed the following elements for each identified operational parameter: potential failure mode, possible causes, and potential consequences. Risk Priority Numbers (RPN) were estimated in a LS3 team effort, the resulting risk prioritization matrix being an effective tool to quantify risks and prioritize activities in relation to the RPN value assigned. Risk control approaches such as risk mitigation or risk acceptance for high RPN values were determined by weighing costs, benefits and customer experience. Sampling measurements, customer complaints, audit results, Corrective and Preventive Actions (CAPA) were also viewed as risk reduction tools. LS3 and its risk management expertise toward cold chain solutions provide high quality standards for healthcare shippers.



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