Practical Aspects of Implementing Quality by Design Practical Aspects of Implementing Quality by...
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Transcript of Practical Aspects of Implementing Quality by Design Practical Aspects of Implementing Quality by...
Practical Aspects ofPractical Aspects ofImplementing Quality by DesignImplementing Quality by Design
Justin Neway, Ph.D.Chief Science Officer, Aegis Analytical Corporation
© 2007, Aegis Analytical Corporation
The New Regulatory EnvironmentThe New Regulatory Environment
A rope line (the well-trodden, historical path)
limits future choices(less innovation)
New technology and a safety line (new
regulatory framework) expands future choices
(more innovation)
© 2007, Aegis Analytical Corporation
Survey ResultsSurvey ResultsQ6 - Which of the following organizations are involved, or will be involved in your QbD
initiative?
Process Development28%
Discovery Research8%
Manufacturing29%
Quality Assurance26%
Other9%
Others Included: Analytical, Automation, IT, Engineering, World Wide Engineering, Regulatory Affairs
© 2007, Aegis Analytical Corporation
To Quote the FDATo Quote the FDA
“ “Continuous learning through data Continuous learning through data collection and analysis over the life cycle of collection and analysis over the life cycle of a product is important. These data can a product is important. These data can contribute to justifying proposals for post-contribute to justifying proposals for post-approval changes. Approaches and approval changes. Approaches and information technology systems that information technology systems that support knowledge acquisition from such support knowledge acquisition from such databases are valuable for the databases are valuable for the manufacturers and can also facilitate manufacturers and can also facilitate scientific communication with the Agency.”scientific communication with the Agency.”
“ “Continuous learning through data Continuous learning through data collection and analysis over the life cycle of collection and analysis over the life cycle of a product is important. These data can a product is important. These data can contribute to justifying proposals for post-contribute to justifying proposals for post-approval changes. Approaches and approval changes. Approaches and information technology systems that information technology systems that support knowledge acquisition from such support knowledge acquisition from such databases are valuable for the databases are valuable for the manufacturers and can also facilitate manufacturers and can also facilitate scientific communication with the Agency.”scientific communication with the Agency.”
© 2007, Aegis Analytical Corporation
Design Space
Quality by Design: The Design SpaceQuality by Design: The Design Space
ControlSpace
Knowledge Space
ControlSpace
© 2007, Aegis Analytical Corporation
Animal studies
Late-stage clinical
trials
Quality by Design: PD & MFG are One TeamQuality by Design: PD & MFG are One Team
Approved product on the
market
Early-stage clinical trials
Compliance Stringency
FDA Consultation, Submission & Approval Process FDA Updates, Inspections & Enforcement
Supply Supply
Develop mid-scale process
Develop large-scale
process
Supply
Develop commercial-
scale process
Supply
Supply
Operate an approved commercial
manufacturing process
Start-up commercial process
Discover lead
compound
Develop small-scale
process
Supply
Economic Stringency
Information to Design for Manufacturing
Develop & Transfer a Process & Design Space
Develop a Clinical Process
Commercial Process
© 2007, Aegis Analytical Corporation
Aspects of CollaborationAspects of Collaboration
• Globalization makes geography a factor in Globalization makes geography a factor in collaborationcollaboration– Centers of excellence/Communities of PracticeCenters of excellence/Communities of Practice
• Rationalization, Right sizingRationalization, Right sizing
– Concentrated and dispersed talentConcentrated and dispersed talent• Local “feet-on-the-ground”Local “feet-on-the-ground”
– Dispersed projectsDispersed projects• Time zones and Political barriersTime zones and Political barriers
– CMOs/TPMsCMOs/TPMs• Business barriersBusiness barriers
– Requires appropriate enabling technologiesRequires appropriate enabling technologies
• Globalization makes geography a factor in Globalization makes geography a factor in collaborationcollaboration– Centers of excellence/Communities of PracticeCenters of excellence/Communities of Practice
• Rationalization, Right sizingRationalization, Right sizing
– Concentrated and dispersed talentConcentrated and dispersed talent• Local “feet-on-the-ground”Local “feet-on-the-ground”
– Dispersed projectsDispersed projects• Time zones and Political barriersTime zones and Political barriers
– CMOs/TPMsCMOs/TPMs• Business barriersBusiness barriers
– Requires appropriate enabling technologiesRequires appropriate enabling technologies
© 2007, Aegis Analytical Corporation
RawMaterials
RawMaterials
ProcessStep 1
ProcessStep 1
ProcessStep 2
ProcessStep 2
ProcessStep 3
ProcessStep 3
ProcessSteps…
ProcessSteps…
FinalProduct
FinalProduct
Data is Accessible in ContextData is Accessible in Context
AG
Deep Dive Analytics forActionable Information in Relevant-timeDeep Dive Analytics forActionable Information in Relevant-time
EDBMESDCSSCADALIMS
PaperRecords
PaperRecords
PaperRecords
PaperRecords
PaperRecords
PaperRecordsERP PRIMR
Customize the Western Electric
rules for your specific process
Key for rules and symbols
Out of control based on Rule 5
CUSUM plot shows when the process changed
Profile line to line up the data
Display several kinds of events by batch
Drill down for more detail
A large number of correlations can be
quickly reviewed
Select individual correlations for
closer examination
Summary information shows
R2 and P-Value
Salt transition
First derivative of
transition
Derived values for trending and specifications
Region selected for variability determination
Region selected for variability
feature extraction
Variability calculated for a specific batch
Erroneous data is excluded
© 2007, Aegis Analytical Corporation
RawMaterials
RawMaterials
ProcessStep 1
ProcessStep 1
ProcessStep 2
ProcessStep 2
ProcessStep 3
ProcessStep 3
ProcessSteps…
ProcessSteps…
FinalProduct
FinalProduct
AG
EDBMESDCSSCADALIMSERP
On-demand Data AccessOn-demand Data Access
Analysis GroupA small subset of the data universe needed now for specific work. Automatically
organized by data type and batch
genealogy
Analysis GroupA small subset of the data universe needed now for specific work. Automatically
organized by data type and batch
genealogy
External ApplicationsExt. ReportsSIMCA, MVA
Etc.
External ApplicationsExt. ReportsSIMCA, MVA
Etc.
PRIMR
© 2007, Aegis Analytical Corporation
PaperRecords
PaperRecords
PaperRecords
PaperRecords
PaperRecords
PaperRecords
ERPLIMS
RawMaterials
RawMaterials
ProcessStep 1
ProcessStep 1
ProcessStep 2
ProcessStep 2
ProcessStep 3
ProcessStep 3
ProcessSteps…
ProcessSteps…
FinalProduct
FinalProduct
Data WarehouseHistorian
Others
AG
On-demand Data AccessOn-demand Data Access
© 2007, Aegis Analytical Corporation
Master Hierarchy for IntegratedAccess PD, MFG, Scales & Sites
Pilot Plant
SCADAPaper
RecordsPaper
RecordsPaper
Records
RawMaterials
ProcessStep 1
ProcessStep 2
ProcessStep 3
ProcessSteps…
FinalProduct
Pre-pilot Development
MESDCSSCADALIMSPaper
RecordsPaper
RecordsPaper
Records
RawMaterials
ProcessStep 1
ProcessStep 2
ProcessStep 3
ProcessSteps…
FinalProduct
Pilot Plant
EDBMESDCSSCADALIMSPaper
RecordsPaper
RecordsPaper
RecordsERP
RawMaterials
ProcessStep 1
ProcessStep 2
ProcessStep 3
ProcessSteps…
FinalProduct
Manufacturing
Manufacturing
Pre-pilot Development
© 2007, Aegis Analytical Corporation
Discoverant: Multi-site CollaborationDiscoverant: Multi-site Collaboration
AG AG
AGSharing
© 2007, Aegis Analytical Corporation
Discoverant: Multi-site CollaborationDiscoverant: Multi-site Collaboration
AG AG
DataSharing
Upstream → → → → → → → → → → Downstream
© 2007, Aegis Analytical Corporation
A Single View of a Dispersed OperationA Single View of a Dispersed Operation
© 2007, Aegis Analytical Corporation
EDBMESDCSSCADALIMS
PaperRecords
PaperRecords
PaperRecords
PaperRecords
PaperRecords
PaperRecords
Discoverant in the System EnvironmentDiscoverant in the System Environment
ManufacturingSystems
© 2007, Aegis Analytical Corporation
Market DataCRM
ERP Data Warehouse
ManufacturingSystems
Discoverant in the System EnvironmentDiscoverant in the System Environment
ProcessDev Web
Services
Dashboards
© 2007, Aegis Analytical Corporation
Its Your ChoiceIts Your Choice
© 2007, Aegis Analytical Corporation
Its Your ChoiceIts Your Choice
© 2007, Aegis Analytical Corporation
Thank you
Justin O. Neway, Ph.D.Executive Vice President and Chief
Science OfficerAegis Analytical Corporation
http://www.aegiscorp.com