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

jneway@aegiscorp.com

http://www.aegiscorp.com