| Compliant Manufacturing with SAP in the Pharmaceutical Industry Extending software applications from top floor to shop floor streamlines compliant manufacturing processes for pharmaceutical companies James Sabogala and Dr. Jürgen Thölkeb SAP Labsa, Newtown Square, PA (USA), and SAP AGb, Walldorf (Germany)
Today, pharmaceutical companies are at a crossroads. Price discounts, shrinking margins, reductions in market exclusivity, product commoditization - as well as Part 11 validation compliance - represent new challenges for pharmaceutical companies of all sizes. Equally daunting are pressures on the supply chain. It is not enough to simply deliver the right active ingredient. It must also be delivered on time, in the right amount, at a high level of quality while maintaining a low safety stock and leveraging existing investments in IT and manufacturing. Along with the pharmaceutical industry’s changes and challenges come new technologies and methods such as radio frequency identification (RFID), Process Analytical Technology (PAT) and Demand-Driven Supply Networks (DDSN) which will require a strategy to control processes from enterprise resource planning (ERP) down to the shop floor.
In the following paper a proposal for such a strategy by using SAP software for compliant manufacturing is described and it is shown how one customer successfully implemented it, cut costs by 10 % and passed a rigorous FDA audit.
Key words Compliance • Pharmaceutical manufacturing • Quality • SAP Manufacturing • Supply Chain Execution |
