Indeed, the terms have evolved with the global growth of the market and with the extension of regulatory reach and oversight—and they continue to do so, according to Kevin O’Donnell, senior partner at Exelsius. “There have been a few overarching or all-inclusive phrases that have been introduced to try and capture this but many seem to become obsolete or fall short with scope expansion – 'cold chain,' 'cool chain,' and 'current Good Distribution Practices for Time and Temperature Sensitive Pharmaceutical Products' – to name a few.
“Supply chain integrity is one that has been bandied about for the past few years representing a more holistic approach to maintaining the quality of the drug product across the spectrum of many processes, which have grown to include manufacturing, intermediate storage, transportation, distribution, security, environmental sensitivities (temperature, humidity, light, shock, vibration), and soon to climb on board, track and trace. This is due in large part to the way the newer generations of many drugs, particularly the highly specialized biological drug manufacturing processes, have gone from inter-plant to international.”
