Presented by Paul Wlodarczyk at Documentation and Training Life Sciences, June 23-26, 2008 in Indianapolis. The creation and management of formulation and control recipes is a process that is overdue for transformation. Today, most pharmaceutical companies still rely on error-prone, manual recipe-management approaches, in which master recipes are treated as static and disconnected documents. These outdated approaches lead to delays in technology transfer and introduce errors as formulations are entered into execution and quality management systems. Inefficient technology transfer, in turn, leads to delays in commercialization, waste or poor yield, compliance challenges, and risks to product quality. Recipe standardization and management can improve every aspect of the product lifecycle, from late-stage discovery through clinical and commercial manufacturing. As pharmaceutical companies increasingly implement Quality by Design principles, recipe standardization will ensure that critical process parameters and their ranges are documented in a uniform fashion, from the earliest phases of process development and then managed effectively through all stages of manufacturing. This slide deck explores new approaches for standardizing recipe management to mitigate risk and accelerate time to market. You will see case studies and be provided with a framework for understanding how to migrate to standards-based recipe-management practices.

1. Transforming Technology Transfer and Recipe Management From Spreadsheets to Standardized Practices Paul Wlodarczyk, VP Solutions Consulting, JustSystems DocTrain Life Sciences 24 June 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 xfy Process Definition Solution 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