SlideShare a Scribd company logo
1 of 14
1
Quality by Design
(QbD)
 Quality by Design (QbD) is a modern, scientific
approach that formalizes product design, automates
manual testing, and streamlines troubleshooting.
 It uses a systematic approach to ensure quality by
developing a thorough understanding of the
compatibility of a finished product to all of the
components and processes involved in manufacturing
that product.
 Instead of relying on finished product testing
alone, QbD provides insights upstream throughout the
development process. As a result, a quality issue can
be efficiently analyzed and its root cause quickly
identified.
 QbD requires identification of all critical formulation
attributes and process parameters as well as
determining the extent to which any variation can
impact the quality of the finished product.
 The more information generated on the impact – or
lack of impact – of a component or process on a
product’s quality, safety or efficacy, the more business
flexibility Quality by Design provides.
 With QbD you will get a proactive approach to
product development, potential to reduce queries and
review time, and the scientific data to quickly get to
the root cause and resolution of any deviation.
QbD development process
a QbD development process may include
 Begin with a target product profile that describes
the use, safety and efficacy of the product
 Define a target product quality profile that will be
used by formulators and process engineers as a
quantitative surrogate for aspects of clinical safety
and efficacy during product development
 Gather relevant prior knowledge about the drug
substance, potential excipients and process
operations into a knowledge space. Use risk
assessment to prioritize knowledge gaps for
further investigation
 Design a formulation and identify the critical material
(quality) attributes of the final product that must be
controlled to meet the target product quality profile
 Design a manufacturing process to produce a final
product having these critical material attributes.
 Identify the critical process parameters and input (raw)
material attributes that must be controlled to achieve
these critical material attributes of the final product.
Use risk assessment to prioritize process parameters
and material attributes for experimental verification.
Combine prior knowledge with experiments to
establish a design space or other representation of
process understanding.
 Establish a control strategy for the entire
process that may include input material
controls, process controls and
monitors, design spaces around individual or
multiple unit operations, and/or final product
tests. The control strategy should encompass
expected changes in scale and can be guided
by a risk assessment.
 Continually monitor and update the process to
assure consistent quality
QbD key components
Defining the Product Design Goal
 In this step, you define the Quality Target Product
Profile (QTPP) and identify all the critical quality
attributes (CQA) for the product.
 The QTPP includes the factors that define the
desired product and the CQAs include the product
characteristics that have the most impact on the
product quality.
 These provide the framework for the product
design and understanding.
 The components are characterized and the
compatibility of the components is evaluated.
Discovering the Process Design
Space
 Understanding your processes is the key to defining
the design space. design space is defined as an
“established multidimensional combination and
interaction of material attributes and/or process
parameters demonstrated to provide assurance of
quality.”
 Critical process parameters (CPPs) are identified by
determining the extent to which any process variation
can affect the quality of the product.
 When you define your design space, you are able to
anticipate issues and plan how to control the process.
 Actual experimental data, product experience, or
literature guidance can be used to define the
extremes of the parameter sets to be refined.
Understanding the Control
Space
 Based on the process design space, a well-executed
control space can be defined.
 This enables you to understand your processes in a
way that ensures product quality from known
variability of the production process.
 This disciplined approach will keep your complex
production processes under control.
 One technique to help avoid such a disparity is to
conduct a Design of Experiments (DOE) study on your
product in the development stage.
 Considerable wasted effort can be eliminated with
such an approach as can any unexpected adverse
outcome from the lack of control space understanding.
Targeting the Operating Space
 The operating space is the best set of
parameters, determined statistically, which enable you
to accommodate any natural variability in CPPs and
CQAs.
 For generic products, the operating space should be
within the control space and should allow a reference
product to be tested with the same set of parameters.
 For new products, the operating space should be
within the design space and compliant with regulatory
guidelines.
 Innovators can gain a competitive advantage by
thoroughly exploring the design space, including
testing multiple batches of formulations to truly refine
their product.
THE BENEFITS OF QbD
• More efficient use of development time and costs
• Ability to meet FDA submission guidelines and
expectations
• Reduced approval times – and fewer queries –
from• More efficient use of development time and
costs
• Ability to meet FDA submission guidelines and
expectations
• Reduced approval times – and fewer queries –
from the FDA
• Rapid response to any manufacturing deviation.
the FDA
THE CHALLENGES OF
ADOPTING QbD
• Insufficient understanding of the process and
its benefits
• Organizational resistance to change
• Denial of the need (“Our process is under
control”)
• Competing priorities
• Lack of resources and expertise in QbD.
Thank you !!!

More Related Content

What's hot

Quality by-Design (QbD) by Mr. Nitin Kadam.
Quality by-Design (QbD) by Mr. Nitin Kadam.Quality by-Design (QbD) by Mr. Nitin Kadam.
Quality by-Design (QbD) by Mr. Nitin Kadam.Nitin Kadam
 
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ROHIT
 
Temperature controlled transport according to current EU GDP
Temperature controlled transport according to current EU GDPTemperature controlled transport according to current EU GDP
Temperature controlled transport according to current EU GDPPauwels Consulting
 
Quality by design
Quality by designQuality by design
Quality by designsuhasini
 
Pharmaceutical Technology Transfer Best Practices
Pharmaceutical Technology Transfer Best PracticesPharmaceutical Technology Transfer Best Practices
Pharmaceutical Technology Transfer Best PracticesAnthony Grenier
 
Quality by design (QbD)
Quality by design (QbD)Quality by design (QbD)
Quality by design (QbD)Neha Dhiman
 
quality by design in pharmaceutical development ICH Q8 guideliness
quality by design in pharmaceutical development ICH Q8 guidelinessquality by design in pharmaceutical development ICH Q8 guideliness
quality by design in pharmaceutical development ICH Q8 guidelinessSUJITHA MARY
 
Quality-by-design(QbD) in pharmaceutical development
Quality-by-design(QbD) in pharmaceutical developmentQuality-by-design(QbD) in pharmaceutical development
Quality-by-design(QbD) in pharmaceutical developmentSteffi Thomas
 
Stabilty study ppt
Stabilty study pptStabilty study ppt
Stabilty study pptpharmacy
 
EVULATION OF PHARMACUTICAL PACAKGING MATERIALS/EVULATION PARAMETERS OF PAKAGI...
EVULATION OF PHARMACUTICAL PACAKGING MATERIALS/EVULATION PARAMETERS OF PAKAGI...EVULATION OF PHARMACUTICAL PACAKGING MATERIALS/EVULATION PARAMETERS OF PAKAGI...
EVULATION OF PHARMACUTICAL PACAKGING MATERIALS/EVULATION PARAMETERS OF PAKAGI...Ashwani Kumar Singh
 
Presentation ICH Q8 annex QbD- november 2008
Presentation ICH Q8 annex QbD- november 2008Presentation ICH Q8 annex QbD- november 2008
Presentation ICH Q8 annex QbD- november 2008Mohamad Haitham Ayad
 
ANDA APPROVAL PROCESS.pptx
ANDA APPROVAL PROCESS.pptxANDA APPROVAL PROCESS.pptx
ANDA APPROVAL PROCESS.pptxPawanDhamala1
 
Validation of tablet process
Validation of tablet processValidation of tablet process
Validation of tablet processPradnya Shirude
 
Quality by design in pharmaceutical development
Quality by design in pharmaceutical developmentQuality by design in pharmaceutical development
Quality by design in pharmaceutical developmentManish Rajput
 
Dist record 112070804007
Dist  record 112070804007Dist  record 112070804007
Dist record 112070804007Patel Parth
 

What's hot (20)

Quality by-Design (QbD) by Mr. Nitin Kadam.
Quality by-Design (QbD) by Mr. Nitin Kadam.Quality by-Design (QbD) by Mr. Nitin Kadam.
Quality by-Design (QbD) by Mr. Nitin Kadam.
 
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)
ICH Q8 GUIDELINES OF QUALITY BY DESIGN(PRODUCT DEVELOPEMENT)
 
Temperature controlled transport according to current EU GDP
Temperature controlled transport according to current EU GDPTemperature controlled transport according to current EU GDP
Temperature controlled transport according to current EU GDP
 
Cosmos guidelines
Cosmos guidelinesCosmos guidelines
Cosmos guidelines
 
Quality by design
Quality by designQuality by design
Quality by design
 
Pharmaceutical Technology Transfer Best Practices
Pharmaceutical Technology Transfer Best PracticesPharmaceutical Technology Transfer Best Practices
Pharmaceutical Technology Transfer Best Practices
 
ICH Q8 Guidelines
ICH Q8 GuidelinesICH Q8 Guidelines
ICH Q8 Guidelines
 
Quality by design (QbD)
Quality by design (QbD)Quality by design (QbD)
Quality by design (QbD)
 
ICH Q8 Guidline
ICH Q8 GuidlineICH Q8 Guidline
ICH Q8 Guidline
 
quality by design in pharmaceutical development ICH Q8 guideliness
quality by design in pharmaceutical development ICH Q8 guidelinessquality by design in pharmaceutical development ICH Q8 guideliness
quality by design in pharmaceutical development ICH Q8 guideliness
 
Quality by Design ( QbD )
Quality by Design ( QbD )Quality by Design ( QbD )
Quality by Design ( QbD )
 
Quality-by-design(QbD) in pharmaceutical development
Quality-by-design(QbD) in pharmaceutical developmentQuality-by-design(QbD) in pharmaceutical development
Quality-by-design(QbD) in pharmaceutical development
 
Stabilty study ppt
Stabilty study pptStabilty study ppt
Stabilty study ppt
 
EVULATION OF PHARMACUTICAL PACAKGING MATERIALS/EVULATION PARAMETERS OF PAKAGI...
EVULATION OF PHARMACUTICAL PACAKGING MATERIALS/EVULATION PARAMETERS OF PAKAGI...EVULATION OF PHARMACUTICAL PACAKGING MATERIALS/EVULATION PARAMETERS OF PAKAGI...
EVULATION OF PHARMACUTICAL PACAKGING MATERIALS/EVULATION PARAMETERS OF PAKAGI...
 
Presentation ICH Q8 annex QbD- november 2008
Presentation ICH Q8 annex QbD- november 2008Presentation ICH Q8 annex QbD- november 2008
Presentation ICH Q8 annex QbD- november 2008
 
ANDA APPROVAL PROCESS.pptx
ANDA APPROVAL PROCESS.pptxANDA APPROVAL PROCESS.pptx
ANDA APPROVAL PROCESS.pptx
 
Validation of tablet process
Validation of tablet processValidation of tablet process
Validation of tablet process
 
Quality by design in pharmaceutical development
Quality by design in pharmaceutical developmentQuality by design in pharmaceutical development
Quality by design in pharmaceutical development
 
Dist record 112070804007
Dist  record 112070804007Dist  record 112070804007
Dist record 112070804007
 
CHANGE CONTROL
CHANGE CONTROLCHANGE CONTROL
CHANGE CONTROL
 

Viewers also liked

QbD and PAT Presentation
QbD and PAT PresentationQbD and PAT Presentation
QbD and PAT Presentationsunp994
 
Quality by design vs control strategy
Quality by design vs control strategyQuality by design vs control strategy
Quality by design vs control strategySurang Judistprasert
 
Quality by design for Pharmaceutical Industries: An introduction
Quality by design for Pharmaceutical Industries: An introductionQuality by design for Pharmaceutical Industries: An introduction
Quality by design for Pharmaceutical Industries: An introductionCovello Luca
 
QbD @ Continous Improvment
QbD @ Continous ImprovmentQbD @ Continous Improvment
QbD @ Continous ImprovmentSantanu Roy
 
Statistics and modelisation for QbD
Statistics and modelisation for QbDStatistics and modelisation for QbD
Statistics and modelisation for QbDAlainPoncin
 
Lean Supply Chain in Pharma Industry
Lean Supply Chain in Pharma IndustryLean Supply Chain in Pharma Industry
Lean Supply Chain in Pharma IndustryBilly Hou
 
Quality by design(paula_ruth_ann)
Quality by design(paula_ruth_ann)Quality by design(paula_ruth_ann)
Quality by design(paula_ruth_ann)abubacker siddiq
 
2011 QbD and More
2011 QbD and More2011 QbD and More
2011 QbD and MoreAlainPoncin
 
Key Components of Pharmaceutical QbD, an Introduction
Key Components of Pharmaceutical QbD, an IntroductionKey Components of Pharmaceutical QbD, an Introduction
Key Components of Pharmaceutical QbD, an IntroductionSaurabh Arora
 
ICH Q8 " PHARMACEUTICAL DEVELOPMENT"
ICH Q8 " PHARMACEUTICAL DEVELOPMENT"ICH Q8 " PHARMACEUTICAL DEVELOPMENT"
ICH Q8 " PHARMACEUTICAL DEVELOPMENT"Talha Mahmood
 
Assessment presentation
Assessment presentationAssessment presentation
Assessment presentationLouise Reed
 

Viewers also liked (20)

Quality by Design
Quality by DesignQuality by Design
Quality by Design
 
Quality by Design
Quality by DesignQuality by Design
Quality by Design
 
QbD and PAT Presentation
QbD and PAT PresentationQbD and PAT Presentation
QbD and PAT Presentation
 
Qbd by Anthony Melvin Crasto for API
Qbd by Anthony Melvin Crasto for APIQbd by Anthony Melvin Crasto for API
Qbd by Anthony Melvin Crasto for API
 
Quality by design vs control strategy
Quality by design vs control strategyQuality by design vs control strategy
Quality by design vs control strategy
 
Quality by Design : Design Space
Quality by Design :  Design SpaceQuality by Design :  Design Space
Quality by Design : Design Space
 
Quality by design for Pharmaceutical Industries: An introduction
Quality by design for Pharmaceutical Industries: An introductionQuality by design for Pharmaceutical Industries: An introduction
Quality by design for Pharmaceutical Industries: An introduction
 
Quality by Design : Control strategy
Quality by Design : Control strategyQuality by Design : Control strategy
Quality by Design : Control strategy
 
Quality by Design : Design of experiments
Quality by Design : Design of experimentsQuality by Design : Design of experiments
Quality by Design : Design of experiments
 
Qbd1
Qbd1Qbd1
Qbd1
 
QbD @ Continous Improvment
QbD @ Continous ImprovmentQbD @ Continous Improvment
QbD @ Continous Improvment
 
Statistics and modelisation for QbD
Statistics and modelisation for QbDStatistics and modelisation for QbD
Statistics and modelisation for QbD
 
Lean Supply Chain in Pharma Industry
Lean Supply Chain in Pharma IndustryLean Supply Chain in Pharma Industry
Lean Supply Chain in Pharma Industry
 
SITE MASTER FILE
SITE MASTER FILESITE MASTER FILE
SITE MASTER FILE
 
Quality by design(paula_ruth_ann)
Quality by design(paula_ruth_ann)Quality by design(paula_ruth_ann)
Quality by design(paula_ruth_ann)
 
Optimization in QBD
Optimization in QBDOptimization in QBD
Optimization in QBD
 
2011 QbD and More
2011 QbD and More2011 QbD and More
2011 QbD and More
 
Key Components of Pharmaceutical QbD, an Introduction
Key Components of Pharmaceutical QbD, an IntroductionKey Components of Pharmaceutical QbD, an Introduction
Key Components of Pharmaceutical QbD, an Introduction
 
ICH Q8 " PHARMACEUTICAL DEVELOPMENT"
ICH Q8 " PHARMACEUTICAL DEVELOPMENT"ICH Q8 " PHARMACEUTICAL DEVELOPMENT"
ICH Q8 " PHARMACEUTICAL DEVELOPMENT"
 
Assessment presentation
Assessment presentationAssessment presentation
Assessment presentation
 

Similar to Quality by design

QUALITY BY DESIGN PPT BY GIRIJA
QUALITY BY DESIGN PPT BY GIRIJAQUALITY BY DESIGN PPT BY GIRIJA
QUALITY BY DESIGN PPT BY GIRIJAGirija Dandu
 
Quality by design (qb d).
Quality by design (qb d).Quality by design (qb d).
Quality by design (qb d).sawantanil
 
Quality by Design and Process Analytical Technology
Quality by Design and Process Analytical TechnologyQuality by Design and Process Analytical Technology
Quality by Design and Process Analytical TechnologyMANIKANDAN V
 
Pharmaceutical Quality by Design (QBD)
Pharmaceutical Quality by Design (QBD)Pharmaceutical Quality by Design (QBD)
Pharmaceutical Quality by Design (QBD)Kushal Saha
 
Pharmaceutical Quality by Design (QbD)
Pharmaceutical Quality by Design (QbD)Pharmaceutical Quality by Design (QbD)
Pharmaceutical Quality by Design (QbD)AnupriyaNR
 
New approach to Process Validation 4
New approach to Process Validation 4New approach to Process Validation 4
New approach to Process Validation 4Santosh Singh
 
Pharmaceutical Qualification & Validation
Pharmaceutical Qualification & ValidationPharmaceutical Qualification & Validation
Pharmaceutical Qualification & ValidationPharmaceutical
 
Quality by design in pharmaceutical development
Quality by design in pharmaceutical developmentQuality by design in pharmaceutical development
Quality by design in pharmaceutical developmentSHUBHAMGWAGH
 
Role of quality by design (qb d) in quality assurance of pharmaceutical product
Role of quality by design (qb d) in quality assurance of pharmaceutical productRole of quality by design (qb d) in quality assurance of pharmaceutical product
Role of quality by design (qb d) in quality assurance of pharmaceutical productNitin Patel
 
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...
PharmaceuticalQuality by Design (QbD)   An Introduction Process Development a...PharmaceuticalQuality by Design (QbD)   An Introduction Process Development a...
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...Bachu Sreekanth
 
Quality by design.. ppt for RA (1ST SEM
Quality by design.. ppt for  RA (1ST SEMQuality by design.. ppt for  RA (1ST SEM
Quality by design.. ppt for RA (1ST SEMCharmi13
 
“Current Approach of Quality by Design” An Overview
“Current Approach of Quality by Design” An Overview“Current Approach of Quality by Design” An Overview
“Current Approach of Quality by Design” An Overviewijtsrd
 
Pharmaceutical Quality by Design (QbD)
Pharmaceutical Quality by Design (QbD)Pharmaceutical Quality by Design (QbD)
Pharmaceutical Quality by Design (QbD)ChinmayGramopadhye
 
QbD.pptx
QbD.pptxQbD.pptx
QbD.pptxAJETHGJ
 

Similar to Quality by design (20)

Quality by design
Quality by design Quality by design
Quality by design
 
QUALITY BY DESIGN PPT BY GIRIJA
QUALITY BY DESIGN PPT BY GIRIJAQUALITY BY DESIGN PPT BY GIRIJA
QUALITY BY DESIGN PPT BY GIRIJA
 
Quality by design (qb d).
Quality by design (qb d).Quality by design (qb d).
Quality by design (qb d).
 
Quality by Design and Process Analytical Technology
Quality by Design and Process Analytical TechnologyQuality by Design and Process Analytical Technology
Quality by Design and Process Analytical Technology
 
Pharmaceutical Quality by Design (QBD)
Pharmaceutical Quality by Design (QBD)Pharmaceutical Quality by Design (QBD)
Pharmaceutical Quality by Design (QBD)
 
Qbd1
Qbd1Qbd1
Qbd1
 
Pharmaceutical Quality by Design (QbD)
Pharmaceutical Quality by Design (QbD)Pharmaceutical Quality by Design (QbD)
Pharmaceutical Quality by Design (QbD)
 
Quality-by-Design by chattar
Quality-by-Design by chattarQuality-by-Design by chattar
Quality-by-Design by chattar
 
Quality of design
Quality of designQuality of design
Quality of design
 
New approach to Process Validation 4
New approach to Process Validation 4New approach to Process Validation 4
New approach to Process Validation 4
 
Pharmaceutical Qualification & Validation
Pharmaceutical Qualification & ValidationPharmaceutical Qualification & Validation
Pharmaceutical Qualification & Validation
 
Quality by design in pharmaceutical development
Quality by design in pharmaceutical developmentQuality by design in pharmaceutical development
Quality by design in pharmaceutical development
 
Role of quality by design (qb d) in quality assurance of pharmaceutical product
Role of quality by design (qb d) in quality assurance of pharmaceutical productRole of quality by design (qb d) in quality assurance of pharmaceutical product
Role of quality by design (qb d) in quality assurance of pharmaceutical product
 
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...
PharmaceuticalQuality by Design (QbD)   An Introduction Process Development a...PharmaceuticalQuality by Design (QbD)   An Introduction Process Development a...
PharmaceuticalQuality by Design (QbD) An Introduction Process Development a...
 
Prospective Validation NSR.pdf
Prospective Validation NSR.pdfProspective Validation NSR.pdf
Prospective Validation NSR.pdf
 
Quality by design.. ppt for RA (1ST SEM
Quality by design.. ppt for  RA (1ST SEMQuality by design.. ppt for  RA (1ST SEM
Quality by design.. ppt for RA (1ST SEM
 
“Current Approach of Quality by Design” An Overview
“Current Approach of Quality by Design” An Overview“Current Approach of Quality by Design” An Overview
“Current Approach of Quality by Design” An Overview
 
Pharmaceutical Quality by Design (QbD)
Pharmaceutical Quality by Design (QbD)Pharmaceutical Quality by Design (QbD)
Pharmaceutical Quality by Design (QbD)
 
QbD.pptx
QbD.pptxQbD.pptx
QbD.pptx
 
Process validation ppt.
Process validation ppt.Process validation ppt.
Process validation ppt.
 

More from Gurparvesh kaur

Training and development @Delhi metro
Training and development @Delhi metroTraining and development @Delhi metro
Training and development @Delhi metroGurparvesh kaur
 
Oprah Winfrey (An Entrepreneur )
Oprah Winfrey (An Entrepreneur )Oprah Winfrey (An Entrepreneur )
Oprah Winfrey (An Entrepreneur )Gurparvesh kaur
 
Sale of goods act, 1930(conditions and warranties )
Sale of goods act, 1930(conditions and warranties )Sale of goods act, 1930(conditions and warranties )
Sale of goods act, 1930(conditions and warranties )Gurparvesh kaur
 
Is India really developing ??
Is India really developing ??Is India really developing ??
Is India really developing ??Gurparvesh kaur
 
Demand and traffic analysis
Demand and traffic analysisDemand and traffic analysis
Demand and traffic analysisGurparvesh kaur
 
Team building intervention
Team building interventionTeam building intervention
Team building interventionGurparvesh kaur
 
human resource practices at Mc.Donald
human resource practices at Mc.Donald human resource practices at Mc.Donald
human resource practices at Mc.Donald Gurparvesh kaur
 
Political factors affecting business environment of bihar
Political factors affecting business environment of bihar Political factors affecting business environment of bihar
Political factors affecting business environment of bihar Gurparvesh kaur
 
organisation development (case study of british airways )
organisation development (case study of british airways )organisation development (case study of british airways )
organisation development (case study of british airways )Gurparvesh kaur
 
How situations influences behavior(conformity )
How situations  influences behavior(conformity )How situations  influences behavior(conformity )
How situations influences behavior(conformity )Gurparvesh kaur
 
Idmst(infrastructure development scheme for small amd medium towns )
Idmst(infrastructure development scheme for small amd medium towns )Idmst(infrastructure development scheme for small amd medium towns )
Idmst(infrastructure development scheme for small amd medium towns )Gurparvesh kaur
 
Umpp(ultra mega power plant and international bidding )
Umpp(ultra mega power plant and international bidding )Umpp(ultra mega power plant and international bidding )
Umpp(ultra mega power plant and international bidding )Gurparvesh kaur
 
Dfccil(dedicated freight corridor)
Dfccil(dedicated freight corridor)Dfccil(dedicated freight corridor)
Dfccil(dedicated freight corridor)Gurparvesh kaur
 

More from Gurparvesh kaur (20)

Brainstorming
BrainstormingBrainstorming
Brainstorming
 
Training and development @Delhi metro
Training and development @Delhi metroTraining and development @Delhi metro
Training and development @Delhi metro
 
Oprah Winfrey (An Entrepreneur )
Oprah Winfrey (An Entrepreneur )Oprah Winfrey (An Entrepreneur )
Oprah Winfrey (An Entrepreneur )
 
Sale of goods act, 1930(conditions and warranties )
Sale of goods act, 1930(conditions and warranties )Sale of goods act, 1930(conditions and warranties )
Sale of goods act, 1930(conditions and warranties )
 
Decentralisation
DecentralisationDecentralisation
Decentralisation
 
WWW Programming Model
WWW Programming ModelWWW Programming Model
WWW Programming Model
 
Is India really developing ??
Is India really developing ??Is India really developing ??
Is India really developing ??
 
Demand and traffic analysis
Demand and traffic analysisDemand and traffic analysis
Demand and traffic analysis
 
Larsen and toubro
Larsen and toubroLarsen and toubro
Larsen and toubro
 
Bharti airtel
Bharti airtelBharti airtel
Bharti airtel
 
Team building intervention
Team building interventionTeam building intervention
Team building intervention
 
human resource practices at Mc.Donald
human resource practices at Mc.Donald human resource practices at Mc.Donald
human resource practices at Mc.Donald
 
Political factors affecting business environment of bihar
Political factors affecting business environment of bihar Political factors affecting business environment of bihar
Political factors affecting business environment of bihar
 
organisation development (case study of british airways )
organisation development (case study of british airways )organisation development (case study of british airways )
organisation development (case study of british airways )
 
How situations influences behavior(conformity )
How situations  influences behavior(conformity )How situations  influences behavior(conformity )
How situations influences behavior(conformity )
 
polygamy
polygamypolygamy
polygamy
 
corporate reputation
corporate reputationcorporate reputation
corporate reputation
 
Idmst(infrastructure development scheme for small amd medium towns )
Idmst(infrastructure development scheme for small amd medium towns )Idmst(infrastructure development scheme for small amd medium towns )
Idmst(infrastructure development scheme for small amd medium towns )
 
Umpp(ultra mega power plant and international bidding )
Umpp(ultra mega power plant and international bidding )Umpp(ultra mega power plant and international bidding )
Umpp(ultra mega power plant and international bidding )
 
Dfccil(dedicated freight corridor)
Dfccil(dedicated freight corridor)Dfccil(dedicated freight corridor)
Dfccil(dedicated freight corridor)
 

Recently uploaded

Travis Hills of Minnesota Leads Livestock Water and Energy in Sustainable Inn...
Travis Hills of Minnesota Leads Livestock Water and Energy in Sustainable Inn...Travis Hills of Minnesota Leads Livestock Water and Energy in Sustainable Inn...
Travis Hills of Minnesota Leads Livestock Water and Energy in Sustainable Inn...Travis Hills MN
 
Principles of Management analyze how Zara manage
Principles of Management analyze how Zara managePrinciples of Management analyze how Zara manage
Principles of Management analyze how Zara managessuser4899c8
 
Organization design fashion or fit by Henry Mintzberg
Organization design fashion or fit by Henry MintzbergOrganization design fashion or fit by Henry Mintzberg
Organization design fashion or fit by Henry MintzbergSana Fatima
 
Presentation On "Yusuf Ibn Tashfin" a true leader (1061 to 1106)_ prepared by...
Presentation On "Yusuf Ibn Tashfin" a true leader (1061 to 1106)_ prepared by...Presentation On "Yusuf Ibn Tashfin" a true leader (1061 to 1106)_ prepared by...
Presentation On "Yusuf Ibn Tashfin" a true leader (1061 to 1106)_ prepared by...kamrulShuva
 
Project Management Professional (PMP)® from PMI
Project Management Professional (PMP)® from PMIProject Management Professional (PMP)® from PMI
Project Management Professional (PMP)® from PMITasnur Tonoy
 
Risk Management in Banks - Overview (May 2024)
Risk Management in Banks - Overview (May 2024)Risk Management in Banks - Overview (May 2024)
Risk Management in Banks - Overview (May 2024)Kristi Rohtsalu
 
UX in an Agile World - Scrum Gathering
UX in an Agile World -   Scrum GatheringUX in an Agile World -   Scrum Gathering
UX in an Agile World - Scrum GatheringKaizenko
 
Create the recognition your teams deserve.pptx
Create the recognition your teams deserve.pptxCreate the recognition your teams deserve.pptx
Create the recognition your teams deserve.pptxStephen Sitton
 

Recently uploaded (8)

Travis Hills of Minnesota Leads Livestock Water and Energy in Sustainable Inn...
Travis Hills of Minnesota Leads Livestock Water and Energy in Sustainable Inn...Travis Hills of Minnesota Leads Livestock Water and Energy in Sustainable Inn...
Travis Hills of Minnesota Leads Livestock Water and Energy in Sustainable Inn...
 
Principles of Management analyze how Zara manage
Principles of Management analyze how Zara managePrinciples of Management analyze how Zara manage
Principles of Management analyze how Zara manage
 
Organization design fashion or fit by Henry Mintzberg
Organization design fashion or fit by Henry MintzbergOrganization design fashion or fit by Henry Mintzberg
Organization design fashion or fit by Henry Mintzberg
 
Presentation On "Yusuf Ibn Tashfin" a true leader (1061 to 1106)_ prepared by...
Presentation On "Yusuf Ibn Tashfin" a true leader (1061 to 1106)_ prepared by...Presentation On "Yusuf Ibn Tashfin" a true leader (1061 to 1106)_ prepared by...
Presentation On "Yusuf Ibn Tashfin" a true leader (1061 to 1106)_ prepared by...
 
Project Management Professional (PMP)® from PMI
Project Management Professional (PMP)® from PMIProject Management Professional (PMP)® from PMI
Project Management Professional (PMP)® from PMI
 
Risk Management in Banks - Overview (May 2024)
Risk Management in Banks - Overview (May 2024)Risk Management in Banks - Overview (May 2024)
Risk Management in Banks - Overview (May 2024)
 
UX in an Agile World - Scrum Gathering
UX in an Agile World -   Scrum GatheringUX in an Agile World -   Scrum Gathering
UX in an Agile World - Scrum Gathering
 
Create the recognition your teams deserve.pptx
Create the recognition your teams deserve.pptxCreate the recognition your teams deserve.pptx
Create the recognition your teams deserve.pptx
 

Quality by design

  • 2.  Quality by Design (QbD) is a modern, scientific approach that formalizes product design, automates manual testing, and streamlines troubleshooting.  It uses a systematic approach to ensure quality by developing a thorough understanding of the compatibility of a finished product to all of the components and processes involved in manufacturing that product.  Instead of relying on finished product testing alone, QbD provides insights upstream throughout the development process. As a result, a quality issue can be efficiently analyzed and its root cause quickly identified.
  • 3.  QbD requires identification of all critical formulation attributes and process parameters as well as determining the extent to which any variation can impact the quality of the finished product.  The more information generated on the impact – or lack of impact – of a component or process on a product’s quality, safety or efficacy, the more business flexibility Quality by Design provides.  With QbD you will get a proactive approach to product development, potential to reduce queries and review time, and the scientific data to quickly get to the root cause and resolution of any deviation.
  • 4. QbD development process a QbD development process may include  Begin with a target product profile that describes the use, safety and efficacy of the product  Define a target product quality profile that will be used by formulators and process engineers as a quantitative surrogate for aspects of clinical safety and efficacy during product development  Gather relevant prior knowledge about the drug substance, potential excipients and process operations into a knowledge space. Use risk assessment to prioritize knowledge gaps for further investigation
  • 5.  Design a formulation and identify the critical material (quality) attributes of the final product that must be controlled to meet the target product quality profile  Design a manufacturing process to produce a final product having these critical material attributes.  Identify the critical process parameters and input (raw) material attributes that must be controlled to achieve these critical material attributes of the final product. Use risk assessment to prioritize process parameters and material attributes for experimental verification. Combine prior knowledge with experiments to establish a design space or other representation of process understanding.
  • 6.  Establish a control strategy for the entire process that may include input material controls, process controls and monitors, design spaces around individual or multiple unit operations, and/or final product tests. The control strategy should encompass expected changes in scale and can be guided by a risk assessment.  Continually monitor and update the process to assure consistent quality
  • 7.
  • 8. QbD key components Defining the Product Design Goal  In this step, you define the Quality Target Product Profile (QTPP) and identify all the critical quality attributes (CQA) for the product.  The QTPP includes the factors that define the desired product and the CQAs include the product characteristics that have the most impact on the product quality.  These provide the framework for the product design and understanding.  The components are characterized and the compatibility of the components is evaluated.
  • 9. Discovering the Process Design Space  Understanding your processes is the key to defining the design space. design space is defined as an “established multidimensional combination and interaction of material attributes and/or process parameters demonstrated to provide assurance of quality.”  Critical process parameters (CPPs) are identified by determining the extent to which any process variation can affect the quality of the product.  When you define your design space, you are able to anticipate issues and plan how to control the process.  Actual experimental data, product experience, or literature guidance can be used to define the extremes of the parameter sets to be refined.
  • 10. Understanding the Control Space  Based on the process design space, a well-executed control space can be defined.  This enables you to understand your processes in a way that ensures product quality from known variability of the production process.  This disciplined approach will keep your complex production processes under control.  One technique to help avoid such a disparity is to conduct a Design of Experiments (DOE) study on your product in the development stage.  Considerable wasted effort can be eliminated with such an approach as can any unexpected adverse outcome from the lack of control space understanding.
  • 11. Targeting the Operating Space  The operating space is the best set of parameters, determined statistically, which enable you to accommodate any natural variability in CPPs and CQAs.  For generic products, the operating space should be within the control space and should allow a reference product to be tested with the same set of parameters.  For new products, the operating space should be within the design space and compliant with regulatory guidelines.  Innovators can gain a competitive advantage by thoroughly exploring the design space, including testing multiple batches of formulations to truly refine their product.
  • 12. THE BENEFITS OF QbD • More efficient use of development time and costs • Ability to meet FDA submission guidelines and expectations • Reduced approval times – and fewer queries – from• More efficient use of development time and costs • Ability to meet FDA submission guidelines and expectations • Reduced approval times – and fewer queries – from the FDA • Rapid response to any manufacturing deviation. the FDA
  • 13. THE CHALLENGES OF ADOPTING QbD • Insufficient understanding of the process and its benefits • Organizational resistance to change • Denial of the need (“Our process is under control”) • Competing priorities • Lack of resources and expertise in QbD.