Quality by Design (QbD) is a systematic, holistic, and proactive approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding through sound science and quality risk management. It involves defining a Quality Target Product Profile (QTPP) and identifying Critical Quality Attributes (CQAs), then linking raw material attributes and manufacturing process parameters to the CQAs. This allows designing a control strategy and establishing a design space to ensure the output meets the QTPP. QbD focuses on continuous improvement throughout the product's lifecycle.

1. QUALITY BY DESIGN IN PHARMACEUTICAL
DEVELOPMENT
 Prepared by : Sonal Suryawanshi
M.pharm ( Sem-II)

2. What is QbD?
 Systematic, holistic and proactive approach to
pharmaceutical development.
 Begins with predefined objectives
 Emphasizes product and process understanding
and process control
 Based on sound science and quality risk
management
Ref.: ICH Q8 (R2)
2
What is Quality by Design (QbD)

4. WHY QBD ???

5.  Quality Target Product Profile (QTPP)
 Define Critical Quality Attributes
(CQAs)
 Perform risk assessment
 Link raw material attributes and
process parameters to CQAs
 Design and implement a control
strategy
 Manage product lifecycle, including
continuous improvement 5
Product profile
CQA’s
Risk
assessment
Design Space
Control
Strategy
Continuous
improvement
Flow of QbD

6. What is QbD?
 Systematic, holistic and proactive approach to
pharmaceutical development.
 Begins with predefined objectives
 Emphasizes product and process understanding
and process control
 Based on sound science and quality risk
management
Ref.: ICH Q8 (R2)
6
What is Quality by Design (QbD)

7. COMPONENTS OF QTPP
Components related to safety, efficacy, identity, purity
and potency
Critical and non-critical components, e.g.
 Critical: Assay, content uniformity
 Non-critical: Appearance
Fixed and variable components
 Fixed elements must be present
e.g. Dosage form, strength
 Variable elements may have a range of acceptable
values
e.g. Tablet weight, assay
7

8. QTPP AND CQAS
QTPP components
Dosage Form
Route of administration
Strength
Weight
Pharmacokinetics
Appearance
Identity
Assay
Impurities
Content uniformity
Friability
Dissolution
Residual solvents
8
CQAs
Assay (efficacy)
Impurities (safety)
C.U. (efficacy)
Dissolution (efficacy)

9. QTPP AND CQAS
QTPP components
Dosage Form
Route of administration
Strength
Weight
Pharmacokinetics
Appearance
Identity
Assay
Impurities
Content uniformity
Friability
Dissolution
Residual solvents
9
CQAs
Assay (efficacy)
Impurities (safety)
C.U. (efficacy)
Dissolution (efficacy)

11. APPROACHES TO PHARMACEUTICAL DEVELOPMENT
Aspects Current QbD
Pharmaceutical
Development
Empirical, Random, Focus on
optimization
Systematic, Multivariate experiments,
Focus on control strategy and
robustness
Manufacturing
Process
Fixed Adjustable within design space,
managed by company’s quality systems
Process Control Some in-process testing PAT utilized, Process operations tracked
and trended
Product
Specification
Primary means of quality control,
based on batch data
Part of the overall quality control
strategy, based on desired product
performance
Control Strategy By testing and inspection Risk-based control strategy , real-time
release possible

12. KEY CHARACTERISTICS OF QBD :
 Dynamic and systematic process
 Relies on the concept that Quality can be built in as a
continuum
 It is applicable to Drug Product and Drug Substance
development (chemicals / biologics)
 It is applicable to analytical methods
 Can implemented partially or totally
 Can be used at any time in the life cycle of the Drug
 Always encouraged by Regulators.

13. ADVANTAGES OF QBD
 Better understanding of the process.
 Less batch failure.
 More efficient and effective control of
change.
 More efficient technology transfer to
manufacturing.
 Risk based approach and identification.
 Innovative process validation approaches

14. Thank you