Process Manufacturing ERP: 6 Rungs on the Ladder of Good Manufacturing Practice

Process manufacturing, in its simplest definition, means that the finished product could not be returned to its initial state because of mixing of component materials or reactions between those materials. GMP, or good manufacturing practice, is required in many businesses such as pharmaceuticals under controls required by government agencies. Fear not, many of these areas of compliance can and should be dealt with by your process manufacturing ERP system.

Formulation or Recipe Control

It is necessary to track every process batch from the start of production to completion and delivery within your process manufacturing ERP system.

Process Documentation

Who worked on each operation and when was the work done? Exact details should be recorded throughout the process so there is a well-documented audit trail within the system whenever it is needed.

Formula Revision Tracking

What ingredients were used in each production batch and exactly when were they introduced and in what quantities?

Quality Checks

Where and when were they done and by whom to what standards? When managing QC through your process manufacturing ERP, it is important to bear in mind the variables which can disrupt these processes. It only takes one error to disrupt the whole system.

Lot Tracking

Incoming lots from any supplier need to be tracked to know what process batches any incoming lot was used in. Then, all production lots or batches need to be tracked to know where these were sold or delivered to. Tracking must be complete and available from the customer to the supplier or in reverse.

Where was the product stored? It is necessary to track the movements and storage conditions such as temperature and light levels from production to delivery.

Regulatory Reporting

Beyond typical financial reporting, each agency has their own ERP requirements and your system should be able to meet those requirements.

Your ideal process manufacturing ERP for a business requiring GMP will include all these with no customization needed. You want a completely stable platform for your business that meets all government regulations. Any customizations open the door to instability. Your ERP needs to enhance visibility to your processes, your profits, controls to reduce costs and to keep quality and reliability at the level your customers and regulators require.