Top 10 Process Manufacturing Requirements for Life Sciences

Batch Manufacturing and Process Manufacturing are very unique processes that Life Sciences companies must address to compete effectively while adhering to FDA quality and validation requirements.   These requirements can even apply before commercialization, or if they outsource certain manufacturing processes.  This mode of manufacturing is unique in that groups, formulas or “Batches” of a product are produced at one time, with the end product taking the form of non-discreet units and something that “Cannot be put back together in their original form”.  This finished product often involves the extraction of 1 or more products at the end of production.  Furthermore, the packaging of the end product needs to be independent of the formula or ingredients so the ability to easily change ingredients doesn’t create added steps to redo the packaging process.

There are ERP systems that specifically address this unique set of functionality, including Microsoft Dynamics AX.  These systems have developed a unique suite of functionality specifically to address these batch and process manufacturing requirements, making it an extremely attractive solution for those industries.  Many times these products have to address the complex issues around multi-site manufacturing as well, where the same product might be produced at different locations.  There is also an important quality assurance requirement with these companies whether at the time of receiving raw material items or quality checks throughout the manufacturing process.

There are some software system requirements that, although not specifically related to the mode of production, tend to be present in batch and process manufacturing environments because of the nature of the industries involved (example: lot number traceability in Life Sciences).

When looking into ERP systems for the process and batch manufacturing industries, the following are some of the key areas to focus attention to and make sure that software was developed with the process industry in mind.

Top 10 Requirements for Life Science Manufacturers:

  1. Lot Number Traceability
  2. Transact Co-Products or By-Products (multiple outputs per production run)
  3. Tracking Batch Records or Batch Attributes
  4. Managing Expiration Dates and Shelf Life of Product
  5. Quality Control and Quality Assurance of Purchased and Manufactured Product
  6. Number of Decimal Places for Tracking Inventory Quantities (when very small quantities of an ingredient are used in formulas or BOM)
  7. Manage Different Versions and Updates to a Formula
  8. Tracking Multiple Units of Measure per Product
  9. Planning and Managing the Packaging of Bulk Product into Multiple Forms Based on Actual Yields
  10. Separate Packaging and Production Process to Allow for Quick Formula Changes

 

There are clear differences in the requirements of a process manufacturer from a discrete manufacturer particularly in the life science industry and it is important that the ERP system can address these unique differences.  Make sure the ERP application was development with the process industry in mind, then drill into how it can address your specific requirements.

This post was written by Andy Collins, Partner at Tridea Partners, a Microsoft Dynamics AX Partner located in Southern California.

More information on how Dynamics AX adresses this industry:

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