This document provides an overview of Quality by Design (QbD), a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science. The key elements of QbD include defining a Target Product Quality Profile, identifying critical quality attributes and critical process parameters, risk assessment, establishing a design space, and developing a control strategy. The objectives of QbD are to identify important product attributes leading to quality, determine attributes that impact product variability, and establish a design space to allow variability in material attributes.

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QUALITY BY DESIGN
Presentedby,
Ms. AsmitaR.Magare
Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune-411044
Guidedby,
Dr. Ms. S. C. Daswadkar
(M.Pharm 2nd year QAT)

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 INTRODUCTION
 OBJECTIVES
 IMPORTANT QBD ELEMENTS
 CONCLUSION
 REFERENCES
CONTENTS

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INTRODUCTION
QUALITY BY DESIGN(QbD)
“A systematic approach to development that begins with predefined objectives and
emphasizes product and process understanding and process control, based on sound
science and quality risk management
Advantages of QbD
 product efficacy are focused.
 Scientific understanding of pharmaceutical process and methods is done.
 It involves product design and process development.
Critical quality attributes are identified and their effect on final quality of product is
analysed.

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OBJECTIVES
To identify the product’s important attributes leading to a quality
product.
To determine the critical quality attributes of a product resulting in a
target product profile, process variability leads to product variability.
To establish design space which provides a wider range within which
material attributes can vary in the future.

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IMPORTANT QbD ELEMENTS
Define Control strategy
Establishment Of Design space
Selection of CQAs & CPP
Risk Analysis
Identify CQAs & CPP
Define TPQP

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Target Product Quality Profile (TPQP)
The target profile is a summary of the drug development program described in the context of
prescribing information goals.
TPQP assets in drug discovery and development process.
 TPQP is related to identity, assay, dosage form, purity, stability in the label.
For example, a typical TPQP of an immediate release solid oral
dosage form would include
– Tablet Characteristics
– Identity
– Assay and Uniformity
– Purity/Impurity
– Stability, and
– Dissolution

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Risk :(Def.) It is define as the combination of the probability of occurrence of harm and the
severity of that harm to the quality of the target product.
Risk Assessment
The evaluation of the risk to quality should be based on
scientific knowledge and ultimately link to the therapeutic
benefit to the patient.
Performing a risk assessment before pharmaceutical
development helps manufacturers decide which studies to
conduct.
Study results determine which variables are critical and
which are not, which then guide the establishment of control
strategy for in-process, raw-material, and final testing.

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(CMA) A physical, chemical, or microbiological property or characteristic of
an input or output material is defined as a material attribute. Ex. particle size,
density, moisture etc.
 (CPP) are process inputs that have a direct and significant influence on critical
quality attributes when they are varied within regular operation range. Ex.
Speed, forces, feeder, hopper etc.
 (CQA) are physical, chemical, biological, or microbiological property or
characteristic that must be controlled directly or indirectly to ensure the quality
of the product
CMA, CPP & CQAs

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Design Space
Design space is define as the multidimensional combination and interaction
of input variables (e.g., material attributes) and process parameters that have
been demonstrated to provide assurance of quality.
Multidimensional space formed by the factor ranges that is used during
method development which assures quality data (robustness).

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Control Strategy
A Control strategy designed to ensure that a product of required
quality will be produced consistently.
In-process control and control of input materials.
Control of CPP and Material Attributes.
Identify sources variability.
End Product Testing.

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CONCLUSION
Quality by Design is everything you do to directly promote & prove the safety, efficacy
and quality of your product.
 Method developed with QbD approach are more robust & rugged, and thus survive the
challenges of long-term usage by QC laboratories with decreased likelihood of failure
 Design Space (DS) for Analytical Methods provides possibility to move inside the DS
without need for post–approval changes in process.
 Method transfer by QbD approach are more successful without need for revalidation for
any Out of specification results.
 It is a starting with end in mind.

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REFERENCES
1. Trivedi B. , Quality by design (QbD) in pharmaceuticals, International Journal of Pharmacy
and Pharmaceutical Sciences.(2012); 4(1) : 1-13.
2. International Conference on Harmonization (ICH) of Technical Requirements for the
Registration of Pharmaceutical for Human use. Pharmaceutical Development: Q8 (R2),
Geneva.
3. International Conference on Hormonization (ICH) of Technical Requirements for the
Registration of Pharmaceutical for Human use. Quality Risk Management: Q9, Geneva.
4. www.ich.org

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