Finished or semi finished products during pharmaceutical manufacturing is a lengthy and involves multiple process and several contract manufacturers and several raw material suppliers at every stage. All it takes is a one defective raw material to cause considerable damage. Due to time critical and sensitive operations which may bring down brands value significantly . The goal is how effectively and in a short time to protect the public from a defective or potentially harmful product. A Solution is required not only to address finished products but to identify where the issue happened. Damage has to be quarantined. A tool that allows for fast and efficient analysis and reporting of product batch or multiple batch distribution records, i.e. where these affected products were sent? A repository of batch related objects and relationships between these objects. These issues are solved using SAP-GBT solution at our one of world's largest pharma customer. Before this, they have no easy way to view the upstream products, suppliers, and customers impacted by a defective batch (bottom-up view). In the same way, there is no view of products, raw materials, orders that fed into that same defective batch (top-down view). This is needed to prevent the future manufacturing or alert all downstream process. Finding a defective product at a customer or on the shelf requires a combination of top-down and bottom-up analysis to determine the breadth of the issue. The complete genealogy, for both upstream and downstream impacted batches and objects, simply cannot be easily determined and reported on. This task can often take many weeks to complete. If the defective batch led to bad press, sickness or at worst a fatality, the timeliness of determining the root cause to mitigate the impact is business critical.

Inconsistent, inaccurate or missing data in the product genealogy leads to an incomplete analysis being performed and often is very difficult even to determine that the chain has not actually ended but is actually continued elsewhere. SAP GBT provides complete end to end product batch genealogies for raw materials, semi finished and finished products. Complexity involves in getting a unified batch genealogy combined with multiple toll manufacturers. In toll manufacturing, corporate provides raw materials (or semi-finished goods) to a third-party/internal plants, who will then provide the rest of the services like manufacturing and supply chain. Our customer product matrix involves over 10K products and having batches older than 10 Years. Getting a unified view is time consuming and a lot of manual work required to consolidate data from multiple plants. This data is required to make sure that quality is ensured across manufacturing. For our customer, in-order to release a finished batch, quality to be checked and approved across manufacturing. Manufacturing can range from days to months and QA alerts should be triggered to business units when quality issues in raw/semi finished products are observed after manufacturing. During finished batch release, if any of child batch has issues or if the issues are identified later, all the finished batches has to be reported for quality audit. Customer needs an integrated view across all plants and easy way to identify and check finished batches before they are released.

Before SAP-GBT implementation, getting these reports/data takes over 24 Hours with a lot of manual work and consolidation. With our expertise and using SAP-GBT as prime solution, we brought down batch release process from days to minutes. In addition to reporting, now QA analysts can easily identify which stages of manufacturing is leading to more quality issues frequently and able to get insights into various toll manufacturers. Apart from this, GBT helps to to get batches shipped to customers and provides a framework for easy re-call due to quality related issues. Now with SAP-GBT using our customized solution, customer is able to release batches faster and accurately and ensuring quality across manufacturing.

For more details and if you are interested about our customized batch genealogy solutions, please let us know at info@s4htech.com