This document discusses Quality by Design (QbD), which is a strategic process for drug development and manufacturing to ensure intended performance in terms of purity and efficacy. QbD has four key components: defining product design goals, discovering the process design, understanding the control space, and targeting the operating space. It is a tool for efficient drug development that relies on building quality in from the beginning. Benefits include eliminating failures, reducing costs, and ensuring consistent quality. Key elements include defining quality targets, identifying attributes, performing risk analysis, determining critical aspects, and establishing a control strategy.

1. BHARGAVI
18Z51R0042
QUALITY BY DESIGN
Geethanjali college of
pharmacy

2. INTRODUCTION
QUALITY :-
Quality cannot be tested into products .
It has to be built in by design.

3. WHAT IS QUALITY BY DESIGN
 Quality by Design (QbD) is a strategic process for
development and manufacturing. It is meant to
ensure that the intended performance of a final drug
product is as expected – both in terms of purity and
efficacy.
 According to ICH Q8 (R2) -“Quality by Design” 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. Quality by
Design is everything you do to improve safety,
efficacyand quality of your product from proof of
concept to the point at which customers are buying it
on a regular basis.

5. COMPONENTS OF QBD
QbD has four key components:
 Defining the Product Design Goal
 Discovering the Process Design
 SpaceUnderstanding the Control Space
 Targeting the Operating Space

6. KEY CHARACTERISTICS OF QBD
 A tool for focused & efficient drug development
 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.

7. BENEFITS OF QBD
 Eliminate batch failures
 Minimize deviations and costly investigations
 Avoid regulatory compliance problems
 Empowerment of technical staff
 Efficient, agile, flexible system Increase manufacturing
efficiency, reduce costs and project rejections and waste
 Build scientific knowledge base for all products
 Better interact with industry on science issues
 Ensure consistent information
 Incorporate risk management
 Reduce end-product testing
 Speed-up release decision

8. KEY ELEMENTS OF QBD
 ICH Q8: Pharmaceutical Development
discusses the various elements of quality by
design. These in combination with the
enablers form the fundamental basis for the
QbD approach to development. Figure 1
provides a pictorial representation of the
typical elements of QbD.It involves the
following key elements during
pharmaceutical development

9. CONTINUATION….
1. Define the Quality Target Product Profile
2. Identify the Quality Attributes
3. Perform a Risk (Assessment) Analysis
4. Determine the Critical Quality Attributes and
Critical Process Parameters
5. Determine the Design Space
6. Identify a Control Strategy

11. REFERENCES
International Journal of Drug Regulatory Affairs; 2015,
3(2), 8-16
IJPQA, Vol4, Issue2, April-June, 2013, 13-19
Available online at www.globalresearchonline.net

12. Thank you