FDA-regulated businesses
The pharmaceuticals industry is regulated by U.S. Food and Drug Administration, FDA. Any system working under these regulations must comply with Current Good Manufacturing Practices, CGMP, a set of rules and regulations that control the methods to be used in manufacturing and business processes. IFS Applications for the pharmaceuticals industry includes functionality for electronic records and electronic signatures in line with the Code of Federal Regulations title 21 CFR Part 11, which provides a set of criteria that equate electronic records and electronic signatures with paper records and traditional handwritten signatures, respectively.
Demand planning
Companies in the pharmaceutical segments often produce and sell their products from stock. A very important key to success in these situations is the ability to make reliable forecasts. IFS Applications offers integrated functionality for demand
planning that interacts with the master schedule. IFS Demand Planning supports several forecasting models and includes functionality for seasonality.
Batch optimization
Pharmaceuticals are often produced against given batch sizes, and every batch normally has to be fully consumed e.g. packed to finished goods level at once, which in a make-to-stock environment means optimizing against forecast. In the batch balancing
functionality the user has a tool that supports the selection of suitable products that are most likely to be needed in stock. Batch balancing also ensures the coherence and traceability of multilevel production.
Potency
Pharmaceutical companies very often handle their key components in variable strength. This means that all material received after a quality inspection is put into stock at its actual strength (potency). In recipes, this is handled by adding a Norm Potency
for the component and a compensatory part to even out any deviating quantity that might appear when a weaker or stronger lot is used.
All your processes supported in one solution
IFS Applications offers comprehensive support for process manufacturing, including the batch balancing functionality mentioned earlier and a traditional shop order/production schedule concept. The application includes advanced recipe handling with
potency control. For product definition it is possible to mix recipes and normal bills of materials. Also, the lot/batch tracking functionality ensures that you can trace the manufacturing process for a product after it has been sold.
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