QbD can be applied to the development and evaluation of analytical methods. During method development, all potential factors (the inputs) and all critical analytical responses (the outputs) are studied to determine the relationships. Critical analytical factors are identified in an approach that parallels what is described for process development in ICH Q8 and Q9. A corporate knowledge repository is required throughout the process to ensure critical information is captured that can be reviewed and added to in the future such that lessons learned can be applied to the specific methods under consideration and also to other similar methods being applied to other products. s

1. Quality by Design
Prepared by :
Noman Khan
M.Pharm [ 2nd Sem ]
Moradabad Educational Trust, Group of
Institutions, Faculty of Pharmacy,
Moradabad - 244001

2. Definition of Quality by Design
QbD describes a pharmaceutical development approach referring
to formulation design and development and manufacturing
processes to maintain the prescribed product quality.

3. Q8 Guidelines of ICH
According to the Q8 guidelines for quality driven development,
“a systematic approach to development that begins with
predefined objectives and emphasize product, process
understanding, and process control, based on sound science ”.

4. 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.

5. 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

6. Opportunities
• Efficient, agile, flexible system
• Increase manufacturing efficiency and reduce costs
• Build scientific knowledge base for all products
• Better interact with industry on science issues
• Ensure consistent information
• Incorporate risk management

8. Quality Target Product Profile (QTTP)
QTTP is “Prospective summary of the quality characteristics of a
drug product that ideally will be achieved to ensure the desired
quality, taking into account safety and efficacy of the drug product”.

9. Critical quality attributes (CQAs)
“A physical, chemical, biological or microbiological property or
characteristic that should be within an appropriate limit, range, or
distribution to ensure the desired product quality”

10. 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

11. Design space
ICH Q8(R2) defines design space as “ the multidimensional
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. Design space is proposed by the
applicant and is subject to regulatory assessment and approval.”

12. Challenges
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