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 These outdated approaches lead to delays in technology transfer and introduce errors as formulations are entered into execution and quality management systems.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.
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Business Imperative: Top ThreeBusiness Imperative: Top ThreeLife Science Innovation Goals for 2012 Life Science Innovation Goals for 2012 1. Leverage scientific/ technological advances to assure superior
therapeutic outcomes in their target patient population.
2. Improve acquisitions/ alliance / licensing management processes to improve agility in bringing new products to market.
3. 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%.
Business Processes Impacting Time-to-Market:Business Processes Impacting Time-to-Market:Early Stage Product and Process Innovation Early Stage Product and Process Innovation
Knowledge of Knowledge of FutureFuture Manufacturing Manufacturing EnvironmentEnvironment
• Result = foundation of process knowledge• Goal = predict manufacturing performance under
commercial operating conditions
Manage Process
Knowledge Creation
Knowledge Knowledge of Chemistry,of Chemistry,Microbiology,Microbiology,PhysicsPhysics
Business Processes Impacting Time-to-Market: Business Processes Impacting Time-to-Market: Late Stage Process Development Late Stage Process Development through Ramp to Commercial Manufacturingthrough Ramp to Commercial Manufacturing
Foundation of Foundation of preliminary preliminary process process knowledgeknowledge
Experience in Experience in ExistingExistingManufacturing Manufacturing EnvironmentEnvironment
Opportunity to use ISA-88 recipe as the common information
model for process definitions?
““Master Data”: Master Data”: Coordination Points for ManufacturingCoordination Points for Manufacturinginclude both Product and Process include both Product and Process
Supply
Demand
Product Design/FormulationDesign/Formulation
Marketing CollateralMarketing Collateral
Service DocsService DocsData SyncData Sync
E-CommerceE-Commerce
Order Acquisition & ManagementOrder Acquisition & Management
Author Process Definitions (“Recipes”)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 trailAutomation requires software development and maintenance
Document Process ParametersDocument 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