Digital solutions for the pharmaceutical industry
Personalized medicine is the future
“How can I profitably produce and release small batches?” The key to future medical care resides in flexible and needs-based production. Here you can discover how Siemens’ digitalization solutions enable the economical production of small batches – thus paving the way for personalized medicine.
Release batches safer and faster
A medication medicine has to go through a highly complex and often very lengthy processes before it can be used to cure. In this process all manufacturing steps have to be recorded precisely. This means massive costs for manual documentation.
The integration of manual and automated processes paves the way to paperless manufacturing
Siemens is paving the way to paperless manufacturing – with the integration of SIMATIC IT eBR and SIMATIC PCS 7 in real time. Electronic user guidance for manual process steps: the system generates electronic work instructions to minimize the risk of error. The employee must confirm correct implementation with an electronic signature. This ensures production reliability. The electronic batch record software solution makes documentation and review easier and more efficient – without breaching the strict standards imposed by the regulatory authorities.
Paperless manufacturing on the basis of the electronic batch record allows review by exception. This means that when a batch is released only deviations have to be reviewed assessed instead of the whole batch documentation. This makes release faster and more efficient.
Benefits at a glance:
- Prevent and reduce errors with more reliable process execution
- Reduce review effort with “Review by Exception”
- Electronic recording and documentation of all production data
- Implementation costs and risks are reduced
Thus, SIMATIC IT eBR plays a key role in cost-effective implementation of the smallest batches – a major step towards personalized medicine.
Alwyn Jones explains how the transition to flexible paperless manufacturing can enable production of more individualised medicines and therapies, with assured data integrity and transparency at every phase of the manufacturing process
In a challenging industry landscape, pharmaceutical manufacturers must adapt manufacturing processes to meet current demands in order to remain profitable and meet patient needs. Continuous manufacturing is playing a vital role in meeting these objectives, by delivering higher productivity, flexibility and lowering the cost of quality.
As pharmaceutical companies are seeking to optimise manufacturing processes and maintain high product quality, continuous methods are a key enabler to building quality by design (QbD) into the complete product lifecycle, from R&D through to manufacturing, with the ultimate aim of getting safer medicines to market in a more efficient and cost-effective way.
Using in-line quality testing enables right first time production, therefore reducing waste and the time typically afforded to product testing, evaluation and batch review.
Transforming the medical supply chain of the future
Alwyn Jones, Head of Pharmaceutical and Life Sciences – Siemens UK and Craig Johnston, Industry Director at CMAC talk about the opportunities of continuous manufacturing for the pharmaceutical industry.