The pharmaceutical industry is being tested like never before. In recent years, we’ve seen many instances of key medicines becoming critically short within healthcare systems globally. This issue has often been attributed to issues around the distribution of the final products. However, in most cases, the reason for these issues is actually from the lack of resilience within the active pharmaceutical ingredient (API) supply chain.
Historically, pharmaceutical supply chains have been designed on just-in-time manufacturing principles.
However, today this is causing issues.
If there is a delay at any point with any raw materials suppliers, or temperature excursions during transport on the cold-chain, it can take months to correct. To improve the resilience of drug supply chains we need to move to a predictive approach.
The Challenges of Drug Manufacturing Logistics
Pharmaceutical supply chains are highly regulated and as a result, there is a high amount of risk associated with each variable within the process. Even small changes in raw material quality or environmental conditions can cause entire production runs to be quarantined.
There are three main causes of issues with drug supply chains.
- Limited Visibility of API’s
Most drug manufacturers will source their raw materials from multiple tiers globally. As a result, without visibility of what is happening at each of these sites, there may be unexpected delays in production caused by regulatory issues or a lack of raw materials.
- Reactive Batch Quality
Issues with batches often only become apparent once a deviation has occurred. Quality assurance staff will often only notice issues once a batch has reached end of line. This can cause delays to production as batches will be quarantined or disposed of altogether causing revenue losses.
- Manual Regulatory Documentation
Maintaining consistency in good manufacturing practice across countries means there is a large amount of data to be processed. Manually processing batch documentation, audit trails and environmental monitoring can cause delays to batch release.
How Top Drug Manufacturers are Addressing These Issues
Top drug manufacturers are using machine learning and predictive analytics to help them predict issues with their supply chain. This means operations teams can proactively make changes based on real-time data.
- Predictive API Shortage Forecasting
Predictive supply chains constantly analyse data from global logistics, trade, geopolitical risks and supplier performance. This can help identify potential raw material shortages weeks or months in advance. This information can then be used by procurement to make changes to their sourcing strategy, and ensure there are no interruptions to production.
- Predictive Batch Quality
By using sensor data and advanced machine learning algorithms, manufacturers can continuously monitor key parameters throughout drug manufacture. Using predictive analytics, operators will be alerted to any changes in environmental/chemical conditions within the batch so they can make changes before they go out of spec.
- GxP Compliance Automation
Using natural language processing and automated audit trails, compliance can be made more efficient. Any deviations from protocols will be flagged up, batch documentation will be verified and serialization requirements met. This will cause a huge reduction in workload.
Drug manufacturers can use enterprise platforms to gain insight into the pharmaceutical supply chain. This can help bring together different areas of the business, reduce batch failures and ensure product is available globally.
3 Ways to Improve Your Supply Chain Resilience
Biopharma manufacturers can improve their manufacturing and distribution by;
Mapping your multi-tier supply chain. Ensure you have visibility of your secondary and tertiary API’s.
Use real-time batch analytics. Reduce waste by using real-time in-line analytics instead of sampling.
Automate your balancing. Use predictive analytics to balance your stock based on disease trends, delays in transport and storage capacity.
By switching to a predictive approach to your logistics, you can protect your margins, ensure compliance and help patients get the medicines they need without interruption.
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