Quality by Design (QbD) is a strategic framework for developing and manufacturing pharmaceuticals to ensure final product performance meets expectations, emphasizing that quality must be built into products by design rather than tested in. The document discusses key aspects of QbD including its objectives, advantages, elements like Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), and how risk management plays a role in quality assurance. Ultimately, implementing QbD aims to reduce variability and enhance efficiency in pharmaceutical product development and manufacturing.

1. QUALITY BY DESIGN
(QBD)
Dipankar Patra
M.Pharm ; QA
186142101004

2. CONTENT
 Introduction
 Concepts and Background of QbD
 Advantages of QbD
 Objectives of QbD
 Key Aspects of QbD
 Conclusion
 Reference

3. Quality:
 Modern definition of quality derives from Juran's "fitness for intended use." This definition basically
says that quality is "meeting or exceeding customer expectations."
 "Quality can not be tested into products; it has to be built in by design"
Definition of QbD :
 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.
Introduction
Concepts Of QbD :
 Quality by Design is a concept first outlined by Joseph M. Juran in various publications.
 He supposed that quality could be planned. The concept of QBD was mention in ICH Q8
guidelines, which states that, "To identify quality can not be tested in products, i.e. Quality
should be built in to product by design."

4. Advantages of QbD
1. Benefits for Industry:
2. Better understanding of the process.
3. Less batch failure.
4. More efficient and effective control of change.
5. Return on investment / cost savings.
Additional opportunities:
1. Reduction of post-approval submissions.
2. More efficient technology transfer to manufacturing.
3. Risk-based approach and identification.

5. Objectives of QBD:
The main objectives of QBD is to ensure the quality products, for that product &
process characteristics important to desired performance must be resulting from a
combination of prior knowledge & new estimation development.
From this knowledge and data process measurement and desired attributes may be
constructed.
Ensures combination of product and process knowledge gained during development.
To increase product development and manufacturing efficiencies

6. Boards of health like the Food and Drug Administration and ICH guidelines Q8,
Q9 and Q10, provide a framework for Quality by Design (QbD).
ICH Guideline • Primarily ICH Q8 through Q10
Q8- Pharmaceutical Development
Q9- Quality Risk Management
Q10- Pharmaceutical Quality System

7. ELEMENTS OF PHARMACEUTICAL QUALITY BY DESIGN
Application of PAT

8. 1. QTPP
 QTPP is a prospective summary of the quality characteristics of a drug product that help to achieved the desired
quality with safety and efficacy of the drug product.
 QTPP forms the basis of design for the development of the product.
 QTPP include the following :
 Intended use in a clinical setting, route of administration, dosage form, and delivery system(s).
 Container closure systems.
 Therapeutic moiety release or delivery which affecting pharmacokinetic characteristic.
 Drug product quality criteria (e.g., sterility, purity, stability, and drug release).
QTPP forms the basis for product design in the following way:
i. Dosage form
ii. Route of administration
iii. Strength
iv. Release
v. Pharmacological characteristic
vi. Drug product quality criteria

9. 2. Critical Quality Attributes
 Identification of the CQAs of the drug product is the next step in drug product development. A CQA
is a physical, chemical, biological, or microbiological property of an output material including
finished drug product that should be within an appropriate limit, range, or distribution to ensure the
desired product quality .
 The quality attributes of a drug product may include identity, assay, content uniformity, degradation
products, residual solvents, drug release or dissolution, microbial limits, and physical properties such
as color, shape, size, odor, and friability.
2.1 Critical Process Parameter (CPPs)
 Critical process parameters (CPPs) are defined as "parameters whose variability have an impact
on a CQA and therefore should be monitored or controlled to ensure the process produces the
desired quality"

10. 3. Risk Assessment
 Quality risk management is a systematic process for the assessment, control, communication
and review of risks to the quality of the drug (medicinal) product across the product lifecycle.
 The initial list of potential parameters which can affect
CQAs can be quite extensive but can be reduced by
quality risk assessment .

11. 4. Design Space
The ICH Q8(R2) States that the design space is multi dimensional combination
and interaction of input variables (e.g., material attributes) and process parameters
that have been demonstrated to provide assurance of quality.
 Working within the design space is not considered as a change.
 Movement out of the design space is considered to be a change and would normally
initiate a regulatory post approval change process
 The relationship between the process inputs (material attributes and process
parameters) and the critical quality attributes can be described in the design
space.

12. 5. Control Strategy
Control Strategy is
 Planned set of controls
 Derived from current product and process understanding that assures process
performance and product quality.
It should include starting materials, intermediates, and finished products.
The elements of the control which contribute to the final product quality include
 In-process controls,
 The controls of input materials (drug substance and excipients),
 Intermediates (in-process materials),
 Container closure system.

13. CONCLUSION
QbD is the effective tool, should be implement from the initial
stage of the product development independent of target market
.
 The goals of implementing QbD in pharmaceutical to reduce
product variability and defects, thereby enhancing product
development and manufacturing efficiencies.

14. 1. INTERNATIONAL JOURNAL OF PURE & APPLIED BIOSCIENCE Quality by
Design (QBD) Approach used in Development of Pharmaceuticals byJyotsna
Balasaheb Jadhavl , Nitin Namdeo Girawale and Rakesh Ashok Chaudhari .
2. Research and Reviews: Journal of Pharmaceutical Quality Assurance Quality by
Design Sushila D. Chavan*, Nayana V. Pimpodkar, Amruta S. Kadam, Puja
S.Gaikwad .
3. WHO Prequalification Programme Priority Essential Medicines Quality by Design
(QbD).
4. ICH Guideline Q8 - Pharmaceutical Development, http://www.ich.org (1 0 Nov
2005).
5. Understanding Pharmaceutical Quality by Design from :National Library of
Medicine.
REFERENCES