At the recent conference, Implementing Manufacturing Execution Systems in the Pharmaceutical and Biotech Industry, Emerson Senior Vice President John Gardner presented with DMI International‘s Bob Schiros a paper on Integrated Recipe Authoring on the first day of the conference. John is the general manager for the Life Sciences, Food and Beverage, Pulp & Paper, Energy, Metals and Mining industry organizations.
The thrust of their presentation is that manufacturers need to integrate their existing “functional islands”. Today people want to get information easier, but that’s just the tip of the iceberg. Integrating and simplifying the management of documents, personnel qualifications, equipment and material, work activity, automation, various plant floor systems, etc. is where the real operational benefits occur.
John stresses the place to begin is to analyze the causes of deviations in these areas. Eliminating these deviations provides the potential operational improvements at the heart of your business case for change. These areas of opportunities should be broken into manageable phases.
Gaining executive sponsorship for the changes is critical since people and processes are likely impacted, and organizational inertia tends to resist changes.
For pharmaceutical and biotech manufacturers, the opportunity comes in reducing the cost of goods manufactured. John stresses the place to begin is to analyze your current functional operations and the causes of deviations in these areas. This will lead to better inventory and yield management, lower regulatory compliance costs, and reduced product release times. John stresses the place to begin is to analyze your current functional operations and the causes of deviations in these areas. Focusing on eliminating these deviations is the most immediate potential improvement and that’s at the heart of your business case for change. These areas should then be broken into manageable phases.
John believes the key is to start with the low hanging fruit which is to have a structured integrated recipe authoring process. The process starts by disassembling the recipe into its components: personnel, materials, equipment, data, and documents. These components are optimized and a database of reusable objects is created. Now the recipe can be reassembled with the optimized components and made available for execution of the batch with its associated electronic batch record.
The presentation highlights measurable results which have been achieved including 40-70% reduction in batch record complexity, 30-50% reduction in product release cycle times, 20-40% reduction in documentation authoring and approval cycle times, and up to 40% reduction in errors, omissions and deviations of operational data.