Turning temperature compliance management into competitive advantage

The dictionary definition of Compliance is “the state or fact of according with or meeting rules or standards”. The typical questions asked within the regulatory compliance circle, be it financial regulations in banking or temperature requirements in food and pharma cold chains, are:

  • How do we manage compliance efforts?
  • How do we reduce compliance costs without having any implications on quality?

Hence, in most organizations temperature compliance is managed with a sense of fear. Uneventful audits from regulators seem to be the goal post. Burning the midnight oil for weeks before the audit day to collect all the necessary records is a norm. A celebration ensues if the audit report is green. And the ambers simply become a part of the next cycle.

We believe that the time is ripe to change the lens with which to look at compliance. How about the following questions:

  • New regulations in US and Europe have significantly expanded the list of medicines that required temperature handling to include products in the controlled ambient (15 to 25C) category. Clearly, regulations aren’t going away – they are only increasing. So, how do we benefit from them?
  • Regulatory guidelines don’t prescribe any specific procedures. Given that regulators are going to ask more questions than give answers during inspections, how do we stay one step ahead of them?
  • How do we turn compliance management into competitive advantage?

While we can’t really comment on how to answer these questions from a policy or organization perspective, we do have some suggestions on leveraging technology to get there. Let us look at a specific case of temperature compliance of Pharma products – drugs and vaccines etc. that are shipped globally.

Here are some of the problems in the current setup and corresponding technology solutions that are already possible:

Current setup

Issues

Solutions

Hardware

Single use data-logger
  • Only temperature
  • High cost of single use
  • Reusable sensors that can monitor temperature, humidity, shock & light
  • One sensor per package, and just one GSM gateway for entire shipment
  • Much lower ‘Total Cost of Ownership (TCO) overall’ even with monitoring every package independently and real-time
If real-time data is needed, GSM based data logger is used.
  • If multiple packages need to be monitored in same shipment, then GSM cost is incurred per package
  • Due to such cost, decision to just monitor single point within shipment is taken

Data and its use

PDF report generated after data-logger plugged into computer via USB drive
  • No digitized data
  • Static report for only that trip
  • Central software platform where every trip is recorded and available for review & analysis perennially
  • Real-time information enables quick interventions
PDF emailed to QA for trip qualification
  • Manual process with multiple emails to various stakeholders
  • No benchmarks for guiding QA
  • Automated trip qualification with time and location of excursions marked
  • QA approval workflow – no email back and forth required
  • Industry benchmarks for MKT variations based on product category

Automated trip qualification report

Data rarely shared with logistics partners, unless temperature excursions occur
  • Cumbersome dispute resolution
  • Only post-mortem of events

 

  • Real-time information on temperature excursions, shock, unauthorized package opening etc.
  • Immediate call to action for logistics partners
  • Clear financial accountability for logistics partners or end customers

 Real time prediction of various risks

Report stored as PDF/excel in some shared drive and only re-looked at or compiled before audits
  • No future utilization of data generated from trip
  • Manual process to compile data for audit  – takes many days and multiple iterations
  • Trips over time can be analyzed to identify routes, transporters, packaging or other issues causing temperature excursions or shock
  • Determining such root causes, helps take systemic actions
  • Report preparation for audit is automated and can be done in just a few hours

Supply Chain Health Analysis

The solution described here doesn’t just setup an organization for better compliance, but also helps save millions on dollars in batch release cycles, product spoilage and damage, delays and other logistics inefficiencies. It helps regulators get the best out of the pharma organizations in less time and build their confidence for future.

Besides the operational efficiencies and improvement in gross margins, this mindset and approach can also be a major source of competitive advantage. The stakeholders and the ultimate consumer are increasingly getting selective about quality of products they support and consume. Time has come when a data driven controlled supply chain with analytics ability can be a major competitive advantage to improve the product quality perception and its uptake.  The companies which can prove better control over the temperature controlled supply chain are able to talk upfront about this capability in their branding efforts and use this unique capability to their competitive advantage.  Many of the drugs are becoming generic with the patent expirations. A well-controlled supply chain can be the unique differential advantage to get a share of the market.

As an example, in a pharmaceutical industry scenario, a physician is more likely to support and prescribe a brand of insulins which has been handled in a controlled data backed temperature control supply chain as insulins are proteins whose structure and activity can get adversely impacted with temperature excursions beyond 2-8 degree Celsius. This change in activity can be disastrous for a diabetic patient who is dependent on this insulin injection for his blood glucose control. More and more physicians and patients are actively looking for companies that can offer the assurance of a superbly well controlled supply chain.

Technology today is offering solutions that can truly be transformative for better compliance, higher margins and offering unique competitive advantage. A shift in mindset and willingness to explore is all it takes!

Authors:

Mukta Arora – Mukta, ex-COO of Eli Lilly, has had various professional Leadership roles in the Pharmaceutical Industry. She has core expertise in various streams of the pharmaceutical value chain viz Business Leadership, People Leadership, Building External R&D Networks and Alliances, Sales and marketing, Supply Chain and Manufacturing with special focus on establishing a Cold Chain for Eli Lilly in the Indian subcontinent.

https://www.linkedin.com/in/mukta-arora-1463402/

Adarsh Kumar – Adarsh is the Co-Founder and CEO of TagBox Solutions. TagBox is enabling organizations make their supply chains more reliable by helping them solve problems like end to end traceability, temperature compliance, spoilage for perishables, physical damage for fragile goods, theft and logistics inefficiencies like delays and TAT.

https://www.linkedin.com/in/adarsh-kumar-4759baa/

www.tagbox.in

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