Some process manufacturers in the food, chemical, nutraceutical and life sciences industries turn to a generic, discrete software application to manage their business. Although these generic applications support their ‘front office’ needs, many process manufacturers discover that these applications do not manage the unique characteristics of their formulas, ingredients and finished goods, which results in several workarounds and inefficiencies.
In this blog, I addressed the advantages of a process manufacturing application over a generic, discrete manufacturing application in quality and regulatory compliance.
Quality
Process manufacturing applications typically come preloaded with a library of industry specific QC tests and special instructions that can applied against received raw materials, WIP products and inventory in storage (e.g. stability tests). Since there’s a high level of variability associated to an inventory’s condition, an unlimited number of user defined quality statuses can be applied to raw materials, intermediates and finished goods in the receiving, production and order fulfilment processes, as well as to inventory in storage based upon the results of QC tests.
Reworking a batch job that has failed inspection involves one or more cycles of adding ingredient quantities or new ingredients in WIP, until the reworked product passes inspection. Process manufacturing applications tightly control the rework process, capturing all variances and inspection results.
Batch job reworks in WIP generate deviation records and customer complaints about delivered goods generate adverse event records. Both situations generate nonconformance and CAPA records that are maintained for process improvement and regulatory reporting purposes.
Regulatory Compliance
Process manufacturing applications generate a variety of industry specific documents and audit reports, including but not limited to FDA nutritional fact panels, nutraceutical supplemental panels, pharmaceutical electronic batch records, and chemical SDS reports and labels.
Lot Traceability & Recall
Lot inheritance is a critical ERP function that is responsible for tracking and tracing the lineage of all raw materials and finished products, including co-products and by-products. Ingredients present in minuscule amounts in a finished good need to be tracked and traced, which is a critical requirement for chemical and pharmaceutical manufacturers.
To meet lot traceability mandates, the generation, capture, validation and reporting of lot controlled raw materials, intermediates and finished goods, including by-products and co-products, is critical.
Lot traceability in many software applications is limited to a “one up and one down” snapshot, meaning information on a product is generated for its current state, one step before its current state and one step after its current state. With graphical traceability maps, process manufacturing systems can perform bi-directional lot traceability searches and product recall in minutes, exceeding the time limits set by the FDA/GHIS and large retailers.
Recommendations
Software architecture built from the ground up for food, chemical, nutraceutical or pharmaceutical manufacturing can help you avoid costly modifications, unnecessary workarounds and risks that come with running a discrete manufacturing ERP application in a process manufacturing environment.
For more information about BatchMaster Software’s quality and compliance capabilities found in our add-on process manufacturing app and end to end ERP solution, please click here for quality management and click here for lot tracability and recall.
Related Blog Posts
What are the software differences in the area of batch production between a process vs discrete manufacturing application? Read our streamlining production blog post.
Product Development requires several unique capabilities found only in process manufacturing applications. Discover these capabilities in this blog post.
