The Impression of Quality by configuration protects by demonstrating that quality is simply not a demonstration, yet it is a propensity. As of late Quality by structure (QbD) has increased a lot of consideration among the pharmaceutical business in extremely short course of time . It goes about as a connection between the business and medication administrative specialists for example (FDA), which is predominantly founded on logical, chance based, all encompassing and proactive methodology for advancement of pharmaceutical item. QbD has helped in making the new detailing, and furthermore the structuring of new method of medication conveyance, just as the better approaches for assembling procedure, and attempts to guarantee the predefined quality items . Key attributes of QbD are that it gives an apparatus to centered and effective medication improvement. It is pertinent to diagnostic strategies. Key components of the Quality by configuration are The Quality Target Product Profile (QTPP), Critical Quality Attributes (CAQ), Design space, Control procedure, lifecycle the executives . Use of value by configuration is in different new looks into dependent on HPLC technique, and we give quit estimation of medication conveyance as indicated by the patients BMR , additionally in Quality by Design in Biopharmaceuticals .

1. B Y - R A J A T K U M A R M I S H R A
B P H A R M A 2 N D
P S I T , K A N P U R
“LET US KNOW ABOUT
QUALITY BY DESIGN IN
PHARMACEUTICAL INDUSTRY”
GUIDED BY - DR ANKITA WAL
HOD PHARMACY
PSIT KANPUR

2. OVERVIEW OF THE QUALITY BY DESIGN
 Objective Of Quality By Design.
 What is Quality by Design (QbD) ?
 Practical Utility of Quality By Design in Pharmaceutical .
 Role of FDA in Quality By Design .
 Benefits of Quality By Design.
 Process Showing How Quality By Design undergoes in Industry.
 Challenges in Quality By Design.
 Conclusion.
 References.

3. Objective Of Quality By Design
 To facilitate innovation and continuous improvement throughout
the product lifecycle.
 To provide regulatory flexibility for specification setting and
post-approval changes.

4. Practical Utility of Quality By Design in Phamaceutical
 The innovative approach is based on the application of product
and process understanding underpinned by a systematic
methodology which can enable pharmaceutical companies to
ensure that quality is built into the product.

5. What is Quality by Design (QbD)?
 According to ICH Q8 (R2)[ International Council for
Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use] : “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 managements”

6. Role of FDA in Quality By Design
 Food and drug administration (FDA) announced proposed
amendments to "Current Good Manufacturing Practices" (cGMP)
in 2002, with an emphasis on establishing a 21st century outlook
on pharmaceutical manufacturing in order to establish a more
systematic science and risk based approach to the development of
pharmaceutical products.

8. Characteristics of Quality by Design
 A tool for focused & efficient drug development.
 It is applicable to Drug Product and Drug Substance development
(chemicals / biologics).
 It is applicable to analytical methods.
 It Can implemented partially or totally.
 It Can be used at any time in the life cycle of the Drug.

9. Advantages Of Quality by design
 Eliminate batch failures.
 Minimize deviations and costly investigations.
 Avoid regulatory compliance problems.
 Empowerment of technical staff .
 Efficient, agile, flexible system.

10. Process Showing How Quality By Design undergoes in
Industry

11. Introduction with the Elements of Quality
By Design
 Define the Quality Target Product Profile.
 Identify the Quality Attributes.
 Perform a Risk (Assessment) Analysis .
 Determine the Critical Quality Attributes and
Critical Process Parameters .
 Determine the Design Space.
 Identify a Control Strategy

12. QUALITY TARGET PRODUCT PROFILE
(QTTP)
 QTTP is widely used in development planning, clinical and
commercial decision making, regulatory agency interactions, and
risk management.

13. QUALITY RISK MANAGEMENT (QRM)
 The FDA defines a Risk Management as, a strategic safety
program designed to decrease product risk by using one or more
interventions or tools.
 It is systematic process for the assessment, control,
communication and review of risks to the quality of the drug
product across the product lifecycle .

14. Risk Assessment and Risk Control

15. Challenges in Quality By Design
 Though Quality by design is an essential part of the modern
approach to pharmaceutical quality, but Lack of understanding
regarding the pharmaceutical process is the cause and also the
major limitation for QbD implementation.

16. Challenges for the Companies
 Lack of belief in business case i.e. there is a lot of
uncertainty over timing of and investment requirements for
QbD implementation.
 Inconsistency of treatment of QbD across regulatory
authority.

17. Conclusion
 QbD is increasingly becoming an important and widely used
technique in pharmaceutical product development.
 QbD is becoming a promising scientific tool in quality assurance
in pharmaceutical industry.

18. References
1. Woodcock J, The concept of pharmaceutical quality. American
Pharmaceutical Review 2004;7: 10–15.
2. Lionberger RA, Lee LS, Lee L, Raw A,Yu LX. Quality by design: Concepts
for ANDAs. The AAPS Journal 2008; 10: 268–276.
3. Q9: Quality Risk Management. ICH Harmonized Tripartite Guidelines.
International Conference on Harmonization of Technical Requirements for
Registration of Pharmaceuticals for Human Use, 2006.
4. Q10: Pharmaceutical Quality System, ICH Tripartite Guidelines. International
Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use, 2007.
5. Q8 (R1): Pharmaceutical Development, Revision 1, ICH Harmonized
Tripartite Guidelines, International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use, 2007.
6. . Gupta A, Fuloria NK. Short review on Quality by design: A new Era of
Pharmaceutical drug development. Int. J. Drug Dev. & Res. 2012; 4:19-26.