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Electronic Batch Records – Improving Quality and Sustainability

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During the 2019 ISPE Meeting & Expo, Lonza and Nephron Pharmaceuticals Corporation will co-present the results of the first implementation of Lonza’s MODA-ES™ Platform, a next-generation electronic batch record (EBR) solution for the pharmaceutical manufacturing industry. Lonza partnered with Nephron, a global leader in the manufacture of generic respiratory medications, to implement the MODA-ES™ Platform, overcoming a number of implementation hurdles and completing the process in an accelerated nine-month timeframe. The successful implementation of the platform has delivered significant operational efficiency gains at Nephron, improving the quality of batch record data and enabling the rapid expansion of its product line without increasing company headcount.

The transition to an Electronic Batch Record has immediate advantages over paper-based documentation, eliminating human error, increasing efficiency and expediting product time-to-market. These benefits are particularly important for pharmaceutical manufacturers wanting to expand their production to meet the rapidly growing global demand for pharmaceutical products. However, such solutions have previously been out of reach for many on account of their prohibitive costs and the great complexity of the implementation process.

Lonza’s MODA-ES™ Platform was developed with the aim to offer a flexible and cost-effective EBR solution, providing an opportunity for a wider portion of the pharmaceutical manufacturing industry to go paperless. The platform combines streamlined data capture and error prevention capabilities with a highly configurable, user-friendly modular design. This means that scaling to a paperless workflow is rapid while offering users the ability to modify manufacturing and quality control data processes to their specific requirements.

The workflow-driven data entry in the MODA™ Platform is also applicable to cleaning forms and capturing QC data, and the platform can be integrated with other GMP-compliant electronic systems and analytical equipment, allowing users to reliably transfer data across their manufacturing and quality-checking infrastructure.