Paperless manufacturing for Genzyme
system (MES) software in its Waterford, Ireland, plant.
The Irish facility, the company's primary tabletting and bottling centre for its kidney dialysis drug Renagel (sevelamer), will benefit from Werum's MES system as part of Genzyme's drive to improve quality, compliance and efficiency at the site. Manufacturing execution systems are software solutions that specify, execute and document all pharmaceutical productions in real-time. With pharma firms increasingly under pressure to ensure regulatory and quality compliance, as well as safe, cost-effective manufacturing techniques, an integrated MES system can help provide an effective platform to handle various business and production processes. According to Werum, its PAS-X software for the pharma industry ensure regulatory compliance whilst also helping to reduce costs and increase productivity. The system covers a range of functions necessary for specification and execution, from materials management to electronic batch recording and also meets 21 CFR Part 11 requirements for handling electronic records and signatures. "[PAS-X] helps in streamlining manufacturing processes, improving product quality, decreasing product cycle times, increasing equipment efficiency and assuring compliance within GMP- [good manufacturing practice] and FDA- [US Food and Drug Administration] regulated production and packaging environments," claims Werum. The software itself is modular is design, allowing companies to pick and choose which particular aspects of the management system are applicable to them. For example, Genzyme has opted for core functions of the software such as master batch record management, electronic batch recording, weighing, material tracking and deviation management. The modular components help to enable a flexible and scalable product configuration, according to the company, allowing a broad spectrum of functionality. Genzyme's Waterford biopharmaceutical facility was the result of a €260m investment, and has been operational since 2003. Coinciding with the implementation of the PAS-X software solution, Genzyme has also commenced a further expansion of the manufacturing site which currently has an annual capacity to produce and pack 800 batches. The renal expansion building will occupy 7,500m2 and will result in 100 per cent increase in tabletting capacity at the site.
