The document discusses Quality by Design (QbD), which is a systematic approach to pharmaceutical development that emphasizes product and process understanding based on sound science. QbD has been adopted by the FDA and aims to design quality into products and manufacturing processes from the beginning. It provides benefits like reduced batch failures, cost savings, and more efficient regulatory oversight. The key aspects of QbD include defining target quality attributes, identifying critical process parameters, establishing a design space, and implementing a risk-based control strategy.

1. Quality By Design
Presented by:-
shashikant maurya
M.Pharm 1st year
(Pharmaceutics)

2. Q b D
QbD has been adopted by the U.S. Food and Drug Administration (FDA) for the
discovery, development, and manufacture of drugs
According to ICH Q 8(R1) QbD is defined as:
 A systematic approach to development that begins with predefined objectives
 It emphasizes on product and process understanding and process control.
 It is based on sound science and quality risk management.
FDA PAT Guidelines define QbD as a system for designing, analyzing and
controlling manufacturing through timely measurements (i.e. during processing) of
critical quality and performance attributes of new and in-process materials and
processes, with the goal of ensuring final product safety.

3.  SIGNIFICANCE OF QbD :
Quality by Design means: designing and developing formulations and manufacturing
processes to ensure a predefined quality
Quality by Design requires: understanding how formulation and manufacturing
process variables influence product quality
Quality by Design ensures: Product quality with effective control strategy
 BENEFITS OF QBD:
 QbD is good Business
 Eliminate batch failures
 Minimize deviations and costly investigations
 Avoid regulatory compliance problems
 Organizational learning is an investment in the future
 QbD is good Science
 Better development decisions
 Empowerment of technical staff

4.  The QbD initiative, which originated from the Office of Biotechnology Products
(OBP), attempts to provide guidance on pharmaceutical development to facilitate
design of products and processes that maximizes the product’s efficacy and safety
profile while enhancing product manufacturability
 IMPROVEMENTS BY QbD:
 Ensure higher level of assurance of product quality for patient
 Improved product and process design & understanding
 Monitoring, tracking & trending of product & process.
 More efficient regulatory oversight
 Efficiency and cost saving for industry
 Increase efficiency of manufacturing process
 Minimize / eliminate potential compliance actions

5.  STEPS INVOLVED IN QUALITY BY DESIGN PRODUCTS
1. Development of new molecular entity
Preclinical study
Nonclinical study
Clinical Study
Scale up
Submission for market Approval
2. Manufacturing
Design Space
Process Analytical Technology
Real time Quality Control
3. Control Strategy
Risk based decision
Continuous Improvement
Product performance

6.  QBD DEVELOPMENT PROCESS 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.
 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.

7.  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.

8. Traditional approach& Enhanced QbDapproach
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

9.  ICH Q8, Q9, Q10 GUIDELINES: THE FOUNDATION OF QbD
 ICH Guidelines Q8 for Pharmaceutical Development
 Q9 for Quality Risk Management,
 Q10 for Quality systems are foundation of QbD
 Quality by Design relative to ICH
 - Concepts aligned
 - Design Space - Key to understanding
 - Process robustness
 - Design of Experiments (DOE)
 - Quality management Quality management
 Critical Concept: Design Space
 Demonstrated to provide assurance of quality
 Defined by applicant and reviewed by regulator

10.  Defined regulator
 Once design space is approved, regulatory post approval change requirements
will be simplified
 Approval Inside vs. outside design space Inside space
 Regulatory flexibility to operate within the design space Regulatory space.

11.  BENEFITS OF IMPLEMENTING QbD FOR FDA
 Enhances scientific foundation for review
 Provides for better coordination across review, compliance and inspection
 Improves information in regulatory submissions
 Provides for better consistency
 Improves quality of review (establishing a QMS for CMC)
 Provides for more flexibility in decision making
 Ensures decisions made on science and not on empirical information
 Involves various disciplines in decision making
 Uses resources to address higher risks

12. Advantages of QbD
 Benefits for Industry:
 Better understanding of the process.
 Less batch failure.
 More efficient and effective control of change.
 Return on investment / cost savings.
 Allows for implementation of new technology to improve manufacturing
without regulatory scrutiny
 Improves interaction with FDA –deal on a science level instead of on a
process level
 Allows for continuous improvements in products and manufacturing process.
 Additional opportunities:
 An enhance QbD approach to pharmaceutical development provides
opportunities for more flexible regulatory approaches.

13.  Pharmaceutical Development: