Line-of-Sight Technique Illuminates Dark Corner—Shipping Validation

ValSource announced, Senior Validation and Risk Consultant Christopher M. Hanff is leading efforts to address what he and his colleagues have identified as critical Active Transport Validation needs and deficiencies within the pharmaceutical, biotechnology and medical device industries.

Speaking to engaged and receptive audiences, Hanff recently addressed Interphex Puerto Rico, PDA, and several other venues on the topic. “Shipping and its validation remain largely undervalued and highly misunderstood.” Hanff continued, “It’s difficult to reconcile how this last, and therefore, one of the most important links in the supply chain, continually merits so little attention.” What’s certain is how detrimental failure to properly execute and validate shipping can be.


“Hidden risk and uncertainty within the supply chain are the natural byproducts of a Quality Management System (“QMS”) with too little emphasis on shipping and its validation,” said Hanff. The most efficient means to properly focus, mitigate, and effectively manage risk in cold chain transportation rely on a proven approach and process. Hanff’s work has helped to ensure reliable delivery of safe products to patients by adapting ValSource’s Line-of-Sight approach to active transport qualification. What’s more is that the Line-of-Sight approach rouses quality improvement opportunities throughout the entire QMS.


By beginning with the end in mind, the Line-of-Sight connects product Critical Quality Attributes to integrity of the cold chain and to shipping validation design. Hanff concluded, “The Line-of-Sight process adds greater value by observing how and where the shipping process intersects with the QMS and the pharmaceutical value chain. This vastly improves and bolsters the value of the pharmaceutical transport program.”

Christopher M. Hanff has over 17 years of experience in biopharmaceutical development, operations, and quality systems. He has worked on and led a number of projects ranging from suite start-ups, design-construction, and commercialization efforts, to pharmaceutical manufacturing management. He has extensive experience in essential quality management systems oversight, design, and remediation, including under FDA sanctioned consent decree. Hanff will continue to lead ValSource’s efforts, advocating for greater efficiency and effectiveness in all areas of Active Transport Validation.