Published in: ProcessNews, Edition 04/04

MES for the Pharmaceutical Industry

Meeting new manufacturing efficiency and quality standards

With the FDA taking up new initiatives in the field of data integrity and integrated quality, and the EU also adopting more stringent regulations concerning product liability, data protection and electronic signatures, the challenges facing pharmaceutical companies, are becoming increasingly complex.

Simatic IT Unilab integrates laboratory data into the production information infrastructure
Simatic IT Unilab integrates laboratory data into the production information infrastructure
The laboratory information management system Simatic IT Unilab helps in collecting quality data and matching these data with quality parameters. It also includes stability testing, and can be an integrated, central factor in the production process, automating sampling and sample approvals and providing real-time interaction with the production floor. Laboratory operations can be optimized in order to support production schedules, facilitating instant information exchange about production schedules and product quality. This integration closes the gap between the laboratory and the production, avoiding bottlenecks that, in the end, could negatively influence the production capacity.
Regulatory compliance
Regulatory compliance is said to become more complicated and costly still, due to legislation related with liability, data protection and electronic signatures such as the FDA regulation 21 CFR Part 11. With the Bio-Terrorism Act, the FDA also forces the pharmaceutical industry to store the production and product genealogy, which means having systems in place that allow traceability of the goods produced, their raw materials, semi-finished and finished products. But the biggest impact will most likely come from the recent FDA PAT (process analytical technology) guideline. This guideline is a result of redesigned regulatory argumentation with a risk- and science-based approach, affecting the operations, quality procedures and validation procedures. PAT asks for an integrated approach to quality in pharmaceutical production, where process analytics, technology and control as well as IT systems are closely networked, providing the basis for quality-by-design, rather than the previously applied quality checks through analyzing samples in the laboratory.

Both market and regulatory pressure require new information management concepts in the pharmaceutical industry
Both market and regulatory pressure require new information management concepts in the pharmaceutical industry
Integrated systems for achieving higher manufacturing efficiency …
Fragmented IT infrastructures with isolated islands of quality and production information from laboratory information management systems and production planning and execution systems will, as such, no longer support regulatory compliance. Another aspect that complicates compliant pharmaceutical manufacturing is the decreasing life cycle of pharmaceutical products. Agility, flexibility and speed in deploying processes are gaining in importance. This implicates that manufacturers need to find a system that will allow them to integrate quality management, while at the same time increasing manufacturing efficiencies and guaranteeing repeatable processes. Through a model- and component-based approach, the manufacturing execution system (MES) Simatic IT ensures performance in both the production and the quality areas by intelligently managing and securing information into the production process. Simatic IT follows the international standard ISA-95 as a blueprint for MES functionality. Its modeling capabilities enable the enforcement of Standard Operating Procedures, thus guaranteeing repeatable processes. Not only does the modeling of procedures help speed up new process development and rapid productions start up, thanks to graphical and visible rules, it is easier and faster to demonstrate repeatability of processes complying with FDA regulations.
… and improved overall performance
Simatic IT combines with and integrates other systems on the business and production level, ensuring the kind of vertical integration that is necessary to increase the plants responsiveness to new requirements. The system can download orders from ERP and assure communication with all production and quality management components. Flexibility of the manufacturing environment is obtained through various components of the Simatic IT Production Suite, managing and coordinating orders, materials, personnel and equipment. Automated, electronically captured data allows for full electronic traceability of equipment, materials and finished goods, including all production data and process steps. Simatic IT also facilitates the generation of the electronic batch records through Simatic IT Report Manager, allowing automatic documentation of every stage in the process, and all materials used. Simatic IT can be integrated seamlessly into existing IT investments. As part of Totally Integrated Automation, it can also be implemented easily in Simatic Batch and Simatic PCS7 applications, providing a tight link between the production and automation layers. Find out more: E-mail: