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In this issue:

• Automation Today - Life Sciences Special Edition
• Ingredients for success
• ProsCon acquisition adds process knowledge and boosts expertise
• Meeting performance and quality goals
• Extended capabilities for Life Sciences Manufacturing Execution System
• Electronic batch recording: the path to paperless production
• Cutting-edge batch production
• Packaging pharmaceutical products: at Imanpack the care is clear to see
• Raising overall equipment effectiveness (OEE)
• Enterprise-wide visibility: the future is within your reach
• Streamlining production processes with MES
• Managing energy costs
• Pharma Automation
• Pharma MES

Pharmaceutical giant aims to improve clinical trial supply chain

German pharmaceutical giant Boehringer Ingelheim is working to speed up its time to market, reduce operating costs, and improve control of its global clinical trial supply chain using Rockwell Automation’s RS PMX CTM solution for Life Sciences.

The Boehringer Ingelheim group (www.boehringer-ingelheim.com) is one of the world’s top 20 pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 137 affiliates in 47 countries and 38,400 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing innovative products of high therapeutic value for human and veterinary medicine.

Key to Boehringer Ingelheim is researching, developing, manufacturing and marketing high therapeutic value medicine

In 2006, Boehringer Ingelheim posted net sales of 10.6 billion euro while spending one-fifth of net sales in its largest business segment Prescription Medicines on research and development.
A daily business objective of Boehringer Ingelheim’s management team is to reduce the time that it takes to bring a product to market. To attain this goal all business processes and systems are regularly reviewed and streamlined whilst helping to ensure compliance is maintained with worldwide regulations, such as Good Manufacturing Practices, and the electronic records and signature guidelines of FDA compliance 21 CFR Part 11.The manufacture, packaging and labelling of Investigational Products (IMPs) within the business is a major area of focus. Clinical studies are changing: they are becoming larger, have more complex study designs, involve more sites in multiple countries, and are being conducted in shorter time frames. In optimising and automating the clinical trial supply chain, Boehringer Ingelheim looked to address all of these challenges.

Successful implementation
Working with Rockwell Automation, the IMP teams at the company’s three major research and production sites in Biberach, Ingelheim and Ridgefield determined that the implementation of a Clinical Trial Supply System using software and hardware technology could be an effective way to meet the worldwide goal of producing clinical supplies faster, more efficiently, and less expensively, while complying with regulatory requirements.
One of the major challenges identified in streamlining the IMP supply chain was the creation of a common database across the three sites to allow access to shared data and processes. The most important areas of common use involved label texts, study data randomisations, and information on materials and batches.

Rockwell Automation deployed a complete recipe/packaging management solution in combination with a warehouse system, comprehensive master data administration, and user role/access rights.
During implementation, it was critical that researchers still had access to information for their clinical trials whilst the improvements were being made, and that production downtime was kept to a minimum. Therefore, speed of deployment of the new database was very important. Six weeks of intensive planning and testing activities within the global teams were carried out to reach this goal. Production stopped at noon one Friday and the system was back up and running the following Monday morning without any restrictions for the users.

The creation of the central database now allows the IMP manufacturer to:
• Generate and process orders from any site
• Design labels in one site and print them at another
• Create and share production procedures as the basis for shop orders across sites
• Create and fulfil study orders at one site, and perform re-supply activities at another site
• Define randomisations at one site and use them at another site as the basis for study orders, shop orders, label printing orders, and emergency codes
• Create medication headers and interval headers at one site, and use them in randomisations at any site
• Establish a shared address book
• Outsource orders from one site, with the provided materials being sent by one site, and the deliverables being received at another site

The implementation of Rockwell Automation’s RS PMX CTM solution for Boehringer Ingelheim is expected to deliver a number of benefits:
• Reduced operating costs while improving throughput and timelines
• Global materials management and traceability
• Global forward and backward genealogy for all supplies, including the tracking of materials from raw material inventory to finished medication kits inventory
• Manufacturing and packaging processes using direct interfaces to other IT systems (SAP), equipment and scales
• Management of manufacturing and packaging equipment
• Variance and deviation management
• Assistance with compliance to electronic records and signature ruling
• Enhanced practices related to Good Manufacturing Practices
• Efficient compilation of, and access to, raw data for regulatory submission report writing

The next steps will cover the global rollout of web-based requests and orders. This will involve the introduction of Unicode font capabilities to support international text phrasing for worldwide labelling in clinical trials, and enhancements in global warehousing and control of goods.

For more information, please e-mail us at: info_at@ra.rockwell.com with, ref: CTM