ISA-88 Batch Control

ISA-88 model

The ISA-88 model defines the recipe, the procedure, the unit procedure, the operation, and the phase.

Recipe and procedure design

The recipe and procedure design covers the master recipe, the site recipe, the master batch record, the site batch record, the equipment dependency, the parameter list, and the material list.

Implementation

The implementation covers the recipe authoring tool, the recipe library, the recipe lifecycle, the change control, the version control, and the integration with the MES.

How to use this page

Use this ISA-88 Batch Control page as a planning checkpoint before vendor selection, architecture review, validation scoping or implementation sequencing. The strongest next step is to compare the guidance with your current SOPs, system inventory, batch records, data flows and QA review routines so the discussion starts from evidence instead of assumptions.

Evidence to prepare

For ISA-88 Batch Control, prepare the records, owners, risks and decision criteria linked to isa-88 model, recipe and procedure design, implementation. Useful evidence includes current process maps, interface lists, audit trail expectations, exception workflows, data retention rules and the business reason for changing the current operating model.

Frequently asked questions