Introduction

To comply with good manufacturing practice (GMP) guidelines, pharmaceutical drug and device manufacturers have traditionally used the batch methodology. However, increasing competition and the trend toward personalized medicines force pharma companies to re-invent their operational strategy.

Pharmaceutical companies face strict regulatory requirements from the US Food and Drug Administration (FDA), such as FDA 21 CFR Part 11 batch processing and the Drug Supply Chain Security Act (DSCSA) for serialization. These and EU regulations have compelled companies to prioritize track-and-trace solutions in their supply chain networks to ensure compliance with serialization requirements at both micro and macro levels.

Global batch tracking is a powerful tool that ensures data integrity, security and effective master data management throughout the entire value chain.

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The good news is that pharma companies have multiple opportunities to implement digital transformation initiatives that leverage Industry 4.0 technologies to improve batch cycle time to market, cash flow and profitability. The goal is an orchestrated batch view encompassing the entire value chain —suppliers, manufacturers and the distribution network —by ingesting and analyzing batch data from disparate systems across the chain.

Industry 4.0 technologies —the Industrial Internet of Things (IIoT), cloud AI- and ML-based analytics, blockchain and paperless manufacturing are transforming manufacturing and supply chain operations by facilitating the tracking of previously inaccessible batch data and providing a deeper understanding of significant operations. IIoT captures batch movement information, while cloud analytics perform advanced predictive analytics to optimize batch cycle times. Further, on the shop floor, advanced analytics provide an understanding of each unit operation in batch processes, driving increased efficiency, productivity and transparency in the manufacturing and supply chain industries.

Challenges in batch tracking

Some significant challenges in batch tracking are:

1. Paper-based manufacturing and supply chain workflows: In traditional pharma manufacturing setups, several workflows and processes collect and record data through paper records. This creates batch-tracking dark spots that significantly inhibit an orchestrated view.
2. Unintegrated systems tracking batch movement: Multiple manufacturing and supply chain systems process and monitor batch operations in silos. Contract manufacturing organizations (CMOs) may also have independent systems for multiple processes. These practices restrict an orchestrated view.
3. Unconnected equipment or legacy systems: Several manufacturers use legacy equipment or systems that work in isolated closed loops, making the correct batch progression data unavailable and preventing an orchestrated view.
4. Poor collaboration among departments: The need for coordination between departments and functions in monitoring pharmaceutical manufacturing prevents a unified and comprehensive view of the operations.

Industry trends

Recent industry trends show that pharmaceutical companies are emphasizing batch tracking more by adopting multiple manufacturing and supply chain systems and solutions.

1. The pharmaceutical manufacturing market is expected to register a CAGR of more than 11% over the forecast period, 2022-2027
2. The biologics contract development and manufacturing (CDMO) market is projected to grow at 12.2% from 2021-2026
3. In the US, the DSCSA will require lot-level tracing to transition to unit-level serialization in November 2023

Global batch-tracking solution framework

In today's complex pharmaceutical manufacturing and supply chain landscape, tracking a manufacturing batch can be challenging. Pharma manufacturing practices vary across different regions, with some organizations relying solely on inhouse production while others adopt a mix of inhouse and outsourced production from CMOs.

HCLTech's solution is designed to address these challenges and provide a comprehensive view of batch tracking. An intuitive user interface tailored to different user roles and actionable workflows offers the benefits of a global batch-tracking solution. Moreover, it provides various connectivity options, enabling seamless deployment across multiple platforms, including on-premises, cloud and hybrid environments.

In both the in-house and CMO models, the global batch-tracking solution does the following:

1. Interfaces with all value chain systems, fully orchestrating and consolidating crucial data from multiple systems across functions via prebuilt connectors for custom and commercial off-the-shelf (COTS) applications
2. Allocates a batch ID to each batch, enabling real-time traceability and trend analysis throughout the batch lifecycle
3. Performs golden batch analysis, predicts golden batch trajectories by comparing parallel batches and provides early warnings on potential deviations via AI or ML-based analytics
4. Allows flexible deployment via a simple user interface on web technologies
5. Simplifies tracking saleable returns of drugs and medical devices
6. Leverages blockchain technology for batch tracking, ensuring data security and compliance

Benefits of global batch tracking

1. Operational efficiency with golden batch analysis: An ideal batch is the dream of every pharma organization; however, in real-life scenarios, it's different, and there are several deviations in the manufacturing and supply chain operations. Effective batch tracking can enhance operational efficiency.
2. Overall Equipment Effectiveness (OEE) improvement: Large chunks of data across the value chain are collected during the tracking of batch movement. This can be effectively utilized for AI- or ML-based predictive analysis for OEE improvements.
3. Predictive compliance and quality: Batch tracking also provides several additional points of the audit trail for precise monitoring. Other proof points improve compliance. With FDA's focus on Quality by Design (QbD), the overall product quality leaps forward.
4. Effective product recalls management: Drug recalls in a regulated industry are very sensitive. Batch tracking effectively traces the drug genealogy.

Conclusion

Global batch tracking is a powerful tool that ensures data integrity, security and effective master data management throughout the entire value chain. It provides meaningful insights and streamlined workflows by integrating and analyzing key parameters from different operations. Pharma companies looking to maximize their success are now turning to global batch tracking as the next step in implementing Industry 4.0 technologies and revolutionizing their operations.

References

1. SAP website (January 2022). SAP Advanced Track and Trace for Pharmaceuticals. Retrieved April 25, 2022, from https://help.sap.com/docs/SAP_ADVANCED_TRACK_AND_TRACE_FOR_PHARMACEUTICALS/c9af81154f504f9aa2795b427855a106/088ccc55614d037ce10000000a44147b.html
2. Pharmaceutical Online website (1999). Batch Tracking & Cycle Time Analysis case study. Retrieved May 11, 2022, from https://www.pharmaceuticalonline.com/doc/batch-tracking-cycle-time-analysis-0001
3. Master Control website (2020, July 10). Four 2019 Manufacturing Batch Record Trends Holding Up in 2020. Retrieved April 15, 2022, from https://www.mastercontrol.com/gxp-lifeline/top-4-manufacturing-trends-impacting-the-batch-record-process-in-2019/