Looking into our Cold Chain Crystal Ball: Regulations & Technology
In this week's blog, Paul Daniel looks at how regulations and technology connect in a feedback loop that can guide the evolution of industry, in Cold Chain as in pharmaceutical and biotechnology manufacturing.
In addition, we offer our new Cold Chain eBook (see attachment below) "Staying Current in Cold Chain," in which Paul Daniel and Piritta Maunu offer their summaries and interpretations of USP 1079 and EU GDP.
Regulations are rarely static. They come into being and evolve over time according to the environment. Such is the case with new Good Distribution Practice (GDP). Formerly, there were no explicit GDP regulations, so they had a genesis. But how do regulations change over time? Usually change occurs because the industry provides feedback to regulators about what works in the real world. This feedback generates balanced, economically feasible solutions, and gives rise to new innovations. For example, in the case of the FDA’s 21 CFR Part 11, new technology for electronic records and signatures (ERES) was emerging and new regulations came into being to control its use. Industry provided feedback that full compliance was neither economical, nor effective.
This dialogue brought a new tool to the forefront: risk assessment. Compared to electronic records, distribution seems simpler. Items move from one location to another. There are no invisible digital bits and bytes However, this simplicity is misleading, because of the massive scale of our global distribution network. Like electronic records, distribution’s degree of complexity creates some similar concerns. With ERES, we are concerned with tampering, authenticity, and unintended changes. With GDP, we have the same concerns, but here the unintended changes that can impact product quality are caused by improper storage and handling.
I predict that, like Part 11, GDP stakeholders will provide feedback on what is technologically possible and economically feasible. The first response will also be similar to Part 11: a risk-assessment approach. Using risk assessment tools, manufacturers can target critical elements of their supply chain with regulatory effort and resources. Already, application of this approach has resulted in more expensive, higher-feedback technologies in the easily controlled distribution legs closest to the manufacturer, and cheaper, lower-feedback technologies (i.e.,single-use data loggers) in more peripheral distribution legs.
These changes will expand slowly for it is very much an educational effort, and its largest barrier is arguably the GMP sophistication of participants on the periphery of the supply chain. Here are my predictions about the next few years of GDP evolution:
1) Technological changes will make GDP compliance more efficient, more reliable, and less expensive.
2) Such changes will be augmented by regulatory pressure to comply with track and trace legislation such as the US Drug Quality and Security Act (DQSA).
3) Big data will be used to access untapped information to better address the challenges of GDP.
What do you think of Paul's predictions? Email us your comments