Process Definition Management using ISA-88 and BatchML

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

Business Imperative: Top Three Life Science Innovation Goals for 2012
Leverage scientific/ technological advances to assure superior therapeutic outcomes in their target patient population.
Improve acquisitions/ alliance / licensing management processes to improve agility in bringing new products to market.
Decrease the concept-to-patient lifecycle from the current 7-11 years to 5-7 years
Survey respondents estimated 19% growth in spending on technology to support R&D in 2012; this is slightly higher among branded and generics with estimated growth of 23%. Mid-market Life Sciences companies also plan for more aggressive growth than their larger counterparts, they plan to increase their spending by nearly 30%. Source: AMR Research 2007 Life Sciences Survey Product Demand Supply

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

Business Processes Impacting Time-to-Market: Early Stage Product and Process Innovation Knowledge of Future Manufacturing Environment
Result = foundation of process knowledge
Goal = predict manufacturing performance under commercial operating conditions
Manage Process Knowledge Creation Knowledge of Chemistry, Microbiology, Physics
Process
Requirements
Meets cGMP?
Safe?
Commercially
viable?
common information models Manage Process Knowledge Discovery Early Stage Product and Process Development: Lab to Bench Scale Pilot Source: Alison Smith, AMR Research Rapid Iterations Product Demand Supply

Business Processes Impacting Time-to-Market: Late Stage Process Development through Ramp to Commercial Manufacturing Foundation of preliminary process knowledge Experience in Existing Manufacturing Environment
Process Improvements
Improves yield?
Reduces variability?
Commercially
viable?
Pilot to Scale Up for Commercial Production Continuous Improvements / Refinements within Design Space 12 – 36 mos. common information models Manage Process Knowledge Sharing Manage Process Knowledge Retention Manage Applying Process Knowledge Opportunity! Source: Alison Smith, AMR Research Product Demand Supply

“ 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

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)

A Solution for Faster Time to Market
Process Definition Management
Define all recipes in a common information model
Build a library of Reusable Manufacturing Actions
Assemble new Recipes from components in library
Benefits:
Standardize on Good Manufacturing Practices
Feedback loop from Manufacturing to Development
Improved technology transfer
Process Knowledge Management
Bottom line: Quality by Design, Faster time to market
Development Process Library Execution Systems Operator Instructions Submission Ready Components Contract Manufacturing Structured Data Sources Common Steps & Actions Common Steps & Actions Commercial Process Library

Key Use Cases in Process Definition Management
Create Reusable Manufacturing Actions (RMAs)
Author Process Definitions (“Recipes”)
Document Process Parameters
Transfer Technology
Manage Knowledge
Create Reusable Manufacturing Actions Author Process Definitions Document Process Parameters Transfer Technology Manage Knowledge

Create Reusable Manufacturing Actions
Challenges:
Process Definition Management requires reuse of codified content (RMAs or recipe building blocks)
No best practice for representing recipes and RMAs outside of manufacturing
No method for implementing reuse
Impacts:
Benefits of recipe normalization are not achieved during Discovery and Clinical phases of lifecycle – time and money left on the table

Author Process Definitions (“Recipes”)
Challenges:
No practice for representing process definitions outside of Batch Control (where ISA-88 is the standard)
No “purpose-built” tools – just spreadsheets and flowcharts
Automation requires custom development
Parameters and flows managed as large documents
Impacts :
Low authoring productivity. Authoring recipes takes months.
Difficult to track changes at an elemental level. No audit trail
Automation requires software development and maintenance

Document Process Parameters
Challenges:
Parameters authored separately from process flows
Spreadsheets are the current best practice – but are 1000s of rows long
No way to link to or standardize “Bills of X”
No established best practice for regulatory reporting of CTQ / KTQs
Impacts:
Low authoring productivity, no way to track/maintain parameters
No element-level change management or audit trail
Disconnected from systems of record
Difficulty supporting Quality by Design

Technology Transfer
Challenges:
Process definitions are represented in human-readable documents, not available as data
Recipes need to be manually entered into Batch Control and execution systems
Impact:
Ineffective and inefficient technology transfer
Quality
Yield
Cycle time

Process Knowledge Management
Challenges:
Document-based approaches to recipe representation
Discovery requires full-text keyword search
Impacts:
Barriers to information discovery and knowledge sharing
Sharing of Good Manufacturing Practices is manual, uneven – lost productivity, gains are not repeatable
No common method of representing “manufacturing process IP”
No mechanism for IP management

What is the Recipe for Addressing these Issues?
Create a purpose-built process definition editor
Make documents “componentized”
Enable valuable content to be extracted and reused from recipes (for knowledge management, RMA, etc.)
Use SFC flowcharts as the means for navigating and accessing the process parameters
Make recipes “machine readable”

Solution: Process Definition Editor
ANSI/ISA 88 for standard look and feel for the “flowchart” user experience
Click on flowchart elements to define critical parameters in forms-based dialogs
BatchML for data representation
Purpose-built process definition editor supports key use cases

What is ISA-88 (“S88”)?
Standard for:
Graphical representation of batch manufacturing processes
Data representation
Three models: physical, process, and control
Widely adopted in Batch Control and MES systems, so familiar to process engineers
Impact:
Easy to use notation
Standardizes the representation of recipes upstream of manufacturing steps in the lifecycle

What is BatchML?
Standard maintained by the World Batch Forum for XML representation of data for all three ISA-88 models
Machine readable – supports transfer of ISA-88 data between systems
As an XML format, can be “rendered” to human-readable forms (e.g. a user interface or documents or both)
Impact:
Captures all ISA-88 data including flows and parameters in a single format
Can be rendered to GUI as ISA-88, trees, forms; or to documents including eCTD for submissions, batch records, etc.
Provides a mechanism for content reuse – Recipe Building Blocks – which is critical to recipe normalization
Solves the technology transfer problem

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

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

Proce s s Definition Editor
Key Benefits
More rapidly create, edit, visualize, reuse data in recipes
Create / capture / reuse process knowledge
Facilitate Quality by Design
Improve CTD submissions
Improve technology transfer
Collaborate with CMOs
Accelerate time-to-market

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Process Definition Management using ISA-88 and BatchML

by Paul Wlodarczyk

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