The document discusses process definition management in the life sciences industry. It outlines challenges around authoring process definitions, documenting parameters, technology transfer, and knowledge management. It proposes using a purpose-built editor with ISA-88 and BatchML standards to address these issues by enabling recipes and components to be authored, visualized, and reused throughout the product lifecycle. This would standardize representations, improve collaboration and technology transfer, and ultimately accelerate time-to-market.

1. Process Definition Management: Using ISA-88 and BatchML as a basis for Process Definitions and Recipe Normalization Paul Wlodarczyk and Mike Power WBF European Conference 11-13 November 2008

3. Product Life Cycle Process Definition Pilot Scale Early Development Late Development Project Management LIMS / SDMS QMS / CAPA Lab Scale Electronic Lab Notebooks Users Project Operations Scientists Chemists Biologists Pharmacists Engineers Technicians Operators Support Analytical Quality MES ERP PLM Development Management Tech Transfer Clinical I Clinical II Clinical III Commercial Experiments Process Unit Procedures Commercial Scale Source: Mike Power, BearingPoint Product Demand Supply

6. “ Master Data”: Coordination Points for Manufacturing include both Product and Process Opportunity to use ISA-88 recipe as the common information model for process definitions? Supply Demand Product Design/Formulation Marketing Collateral Service Docs Data Sync E-Commerce Order Acquisition & Management Supply Chain Planning (mBOM, Routing) Sourcing & Procurement Product Package Design/ Label Claims Recipe Management Detailed Routing Bill of Equipment Bill of Process Bill of Compliance/ CoA Bill of Test Asset Maintenance Bill of Materials Process Specifications Process Engineering Maintenance Plans SOPs Asset Performance Management Opportunity to use ISA-88 recipe as the common information model for process definitions? Opportunity to use ISA-88 recipe as the common information model for process definitions? common information models

7. ISA-88 Operations Ice Cream Recipe Example The Blend Ingredients Operation - eight phases associated with blending ingredients. Note there is no rule on running only one phase at a time. In fact, it is very common for multiple phases to be running simultaneously. Recipe represented in an industry standard ISA-88 SFC (sequential function chart)

19. The Process Definition Editor BatchML storage of recipes and recipe building blocks ISA-88 Editor for visual editing and navigation of Process Definitions Drawing palettes for ISA-88 shapes and reusable components Double-click on shapes to drill down, add process parameters

20. Product Life Cycle Process Definition Pilot Scale Early Development Late Development Project Management LIMS / SDMS QMS / CAPA Lab Scale Electronic Lab Notebooks Users Project Operations Scientists Chemists Biologists Pharmacists Engineers Technicians Operators Support Analytical Quality MES ERP PLM Development Management Tech Transfer Clinical I Clinical II Clinical III Commercial Experiments Process Unit Procedures Commercial Scale Source: Mike Power, BearingPoint Process definition tools facilitate early process development 1 Process definitions refined, tech transfer at every point of scale 2 4 Tech transfer improved through machine-readable BatchML Process definitions transformed into ISA-88 control recipes in MES or Batch Control System 5 Manufacturing knowledge transferred to development through library of reusable process actions 6 ISA-88 recipes used for Description of Manufacturing Process & Process Controls (section 3.2.S.2.2) of CTD. 3