qbd (quality by design)- a tool to success “trials and ... · putting science to work qbd process...
TRANSCRIPT
QbD (Quality by Design) - A Tool to Success
Dr. Jegadeesh Thampi, Ph.DVice President & Head, Chemical Development
Putting Science to Work
Why do we need QbD ?
Missed launch date
Drug shortage
Low RoI
Compromised patient
safety
Bad reputation
Product recalls
Batch to batch variation
Batch failure
Process inconsistency
Impurities
Validation failures
Putting Science to Work
The Genesis
Outsourcing in the medical device industries in 90’s resulted in:
Components being manufactured across geographical locations and assembled at one site
Challenges in fitment of components, meeting design specifications and quality criteria
Putting Science to Work
How QbD helps Pharmaceutical outsourcing?
What is driving drug development?
Extensive outsourcing of small and large molecules
Blurring of boundaries of drug development continuum: Geographies and organizational boundaries
(extension of organizations)
Fully integrated networks of development and manufacturing
Pharmaceutical industry adopted QbD concept for drug development
QbD plays a vital role in bridging specifications and quality, especially for CMOs
Putting Science to Work
QbD and CMOs
Innovator/CROs
Discovery & Early phase
development
Late phase development
CMOs
Commercial manufacturing
Innovator/CROs
API/Intermediate/RSM/DP
DP/Market product
QbD plays a critical role, when components are developed/manufactured globally
Putting Science to Work
Development ManufacturingDiscovery
PATQbD
DoE
PCJ
SS
QBD Quality by Design
DoE Design of experiments
PCJ Process control justification
PAT Process analytical technology tools
SS Six sigma
QbD accelerates development and manufacturing
Extent of QbD in Drug Development
Extent of QbD, DoE, PCJ Phase appropriate development Fit to purpose
Putting Science to Work
Are QbD and Six Sigma different?
QbD
DFSS (Six sigma)DFSS: Design for Six sigmaProcess Design- DMADV: Define, measure, analyse, design and verifyProcess Improvement- DMAIC: Define, measure, analyse, improve and control
Define Quality target product profile (QTPP)
Define
Process map & Risk
assessment
Measure
Experimentation
Analyze
Develop design Space
Design
Control strategy
Verify
Putting Science to Work
QbD Process flow
Designing and Implementation of Control Strategy
Literature, Chemistry, Target and deliverables
through Systematic and
Holistic approach
Process Understanding
Critical Quality Attributes (CQA) of Product
Process Mapping
Risk Assessment
Design Space Development
QTPP, CPP, KPP, non-KPP including
measurement methods
QTPP, CPP, KPP, non-KPP including
measurement methods
What-if, HAZOP, FMEA, C&E,
PHA, FTA, RCA, HACCP, PRA
DoE, OFAT, PCJ, Transfer functions
Acceptance criteria,
Tolerance limits, Life cycle
management plan
Putting Science to Work
QbD Methodology
Process Map FMEA
Experimental plan
C & E Matrix
DoE
One Factor Experiments
Optimized parameters
Scale Up
Putting Science to Work
Example
Process map
CQAs
C & E Matrix
FMEADesign Space
Putting Science to Work
Summary
QbD
FDA Perspective,
Short Reviews
Higher Profitability, Excellence,
Meeting launch dates,
Patient safety,
No drug shortage
Reliability, Reduced
Variability and Rework
Better lifecycle
management
Regulatory
Process
Understanding Impact
Contact Us For more details
• Visit www.syngeneintl.com
• For specific queries, you can write to [email protected]
• For details on Syngene’s Services: [email protected]