May 6, 2025

Quality is a dynamic chain, and each link is important to deliver a GMP product.  And quality is tied directly to revenue.

In our last blog, we highlighted the importance of adding quality data to inventory in regulated industries. To achieve end-to-end traceability with resource control in a GMP environment, a regulated producer needs to complete documentation for all activities that make, analyze, and approve the product to that inventory system.

An Electronic Batch Record (EBR) does this when connected to a GMP designed inventory system. Here’s how this combination can manage production to create efficiency by reducing paperwork and the chance for human error:

• Traceability- using an integrated GMP inventory/EBR system provides easy inquiries of the components in a finished good, and where a given ingredient was used in a range of completed products.
• Material Management- at any point in manufacture, adding the correct quantity of specification-approved material is critical to the success of downstream operations.
• Staging and Dispensing- creating traceable picklists promotes operational efficiency by readying stored material for use.
• In Process Tests– identify success at key checkpoints to quickly ensure purity of the product and identify problems
• Engagement of production-ready equipment minimizes unexpected quality problems in operation.

Why this combination of Inventory and EBR is important

In production, a lot can happen to alter the quality of the item on its way to completion. All manufacturing processes contain a possibility of deviation from the plan. That is why the sum of tested and verified materials for a finished good is not automatically an approvable finished good.  A reliable, configurable EBR is needed to document the progress of activities, and check the results at points where a process is most likely to impact the quality of the product.

Upon approving the EBR, the newly finished item is received again and subjected to a new set of tests and methods before it can be shipped.

Additionally, some production processes are designed to create intermediates (work in process) where the end products in turn are the ingredients.  A configurable EBR system can link a series of separate operations when the overall efficiency of sequencing is advantageous.

InstantGMP was built by design to cover the requirements of quality-informed material management, as well as those of a highly configurable EBR workflow.

The InstantGMP EBR is designed to accurately model and guide GMP traceability and documentation from receipt to release, and work with our quality-enabled inventory system for full-strength GMP throughout.

To learn more about the benefits the “power chain” of GMP inventory and configurable EBR can reveal for you, just call us or visit www.instantgmp.com