Section,Engineering question,Required output,Minimum evidence,Typical owner,Status,Notes
Model basis,Is the product and quality target defined?,Product specification and critical quality targets,Approved product brief and target product profile,Process development,Not assessed,
Model basis,Is the process boundary explicit?,Included and excluded operations plus system boundary,Reviewed block flow diagram and modelling scope,Process engineering,Not assessed,
Model basis,Is the operating mode defined?,Batch fed-batch perfusion or continuous basis,Recipe and campaign definition,Process development,Not assessed,
Components,Are all material components registered?,Component inventory with phase and composition,Raw-material specifications and analytical methods,Process engineering,Not assessed,
Mass balance,Does total mass close?,Overall closure within agreed tolerance,Measured or reconciled flow and inventory data,Process engineering,Not assessed,
Mass balance,Do critical components close?,Component balances for product substrate metabolites buffers and waste,Assay data yields and concentration measurements,Process development,Not assessed,
Energy balance,Are heating and cooling duties reconciled?,Unit-level and facility-level energy duties,Temperatures heat capacities utility conditions and measured duties,Utilities engineering,Not assessed,
Reactions,Are stoichiometry and yield definitions traceable?,Reaction network and yield basis,Experimental data literature or approved platform knowledge,Process development,Not assessed,
Kinetics,Are growth production and uptake kinetics calibrated?,ODE or PDE parameter set with fit quality,Time-series experiments with uncertainty,Modelling lead,Not assessed,
Physical limits,Are oxygen transfer and heat removal checked?,Operating envelope for kLa OUR OTR and heat duty,Scale-specific geometry agitation aeration and fluid properties,Process engineering,Not assessed,
Physical limits,Are metabolite and osmolality boundaries defined?,Limits for ammonium lactate osmolality pH and nutrients,Measured process data and literature basis,Process development,Not assessed,
Equipment,Is every process duty assigned to equipment?,Equipment register with duty size material and design basis,Equipment data sheets and supplier information,Plant engineering,Not assessed,
Equipment,Are working volumes and turndown realistic?,Minimum normal and maximum operating volumes,Vendor data and site operating practice,Plant engineering,Not assessed,
Equipment,Are filters columns and membranes sized?,Area cycle count flux capacity and lifetime,Scale-down studies supplier data and batch records,Downstream development,Not assessed,
Streams,Does every required inlet and outlet exist?,Complete stream table including utilities emissions and waste,Flowsheet review and source-destination reconciliation,Process engineering,Not assessed,
Cleaning,Are CIP SIP and turnaround states modelled?,Cleaning recipes durations chemicals utilities and release,Site SOPs and skid capacity,MSAT,Not assessed,
Scheduling,Are shared resources and dependencies modelled?,Finite-capacity campaign schedule with waits and holds,Recipes calendars changeovers and resource constraints,Manufacturing planning,Not assessed,
Scheduling,Are hold-time limits enforced?,Maximum hold and queue constraints,Stability studies SOPs and process validation,MSAT,Not assessed,
Utilities,Are clean and plant utilities capacity checked?,Peak and average WFI steam cooling gas and electrical loads,Site utility data and metering,Utilities engineering,Not assessed,
Labour,Are staffing and room constraints represented?,Shift demand role coverage and room occupancy,Site staffing model and operating procedures,Operations,Not assessed,
Economics,Are material and consumable costs current?,Traceable unit costs with region date and range,Supplier quotes contracts or indexed assumptions,TEA lead,Not assessed,
Economics,Are CAPEX assumptions source-backed?,Purchased installed and facility cost basis,Supplier quotes cost indices and installation factors,Project controls,Not assessed,
Economics,Are utilization and annual throughput credible?,Annual batches downtime maintenance failure and release assumptions,Production history or approved planning basis,Manufacturing planning,Not assessed,
LCA,Is the inventory complete and consistently bounded?,Material energy water transport emissions and waste inventory,Primary data and documented secondary datasets,LCA lead,Not assessed,
Uncertainty,Do critical inputs have intervals and distributions?,Low base high values and distribution rationale,Replicates supplier ranges or expert elicitation,Modelling lead,Not assessed,
Sensitivity,Are dominant decision drivers identified?,Local and global sensitivity results,Reviewed parameter ranges and repeatable run settings,TEA lead,Not assessed,
Data quality,Does every important input have a source and owner?,Source register with quality date and ownership,Controlled references and data governance,Quality assurance,Not assessed,
Validation,Has the model been compared with an authorized reference?,Acceptance report with residuals and deviations,Customer-owned baseline pilot or historical batch data,Independent reviewer,Not assessed,
Governance,Are versions branches approvals and changes traceable?,Audit trail and reviewed model release,Identity roles review workflow and retention policy,Quality assurance,Not assessed,
Exports,Can reviewers reproduce the decision outside the tool?,Detailed workbook CSV SVG and complete model package,Automated export tests and independent file-opening check,Model owner,Not assessed,