Recipe Management and Master Batch Records

ISA-88 recipe model

The ISA-88 (IEC 61512) recipe model defines the recipe structure: recipe, procedure, unit procedure, operation, and phase.

Master recipe library

The master recipe library is the authoritative set of recipes used for production. The library includes the recipe, the master batch record, the associated procedures, the material list, the equipment list, and the parameter list.

Recipe lifecycle

The recipe lifecycle covers the creation, the review, the approval, the version control, the change control, the retirement, and the archival.

Recipe authoring tools

Modern MES platforms provide recipe authoring tools that support the ISA-88 model, the master recipe library, the version control, and the integration with the production execution.

How to use this page

Use this Recipe Management and Master Batch Records 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 Recipe Management and Master Batch Records, prepare the records, owners, risks and decision criteria linked to isa-88 recipe model, master recipe library, recipe lifecycle, recipe authoring tools. 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