A presentation covering QbD inclusive of its definition, goals, advantages, QTTP, Risk Assessment Methods, Design of experiment, Life Cycle Management, etc.,

1. QUALITY BY DESIGN
By:-
Lalit
M.Pharm (Quality Assurance)
Delhi Institute Of Pharmaceutical Science And
Research

2. Quality By Design :-
 Quality by Design (QbD) refers to a new
approach to product development that
could increase efficiencies, provide
regulatory relief and flexibility, and
offer important business benefits
throughout the product life cycle.
 QBD is defined in ICH Q8 guideline as
“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”.

3. Goals Of QBD :-
 To achieve meaningful product
quality specifications that are
based on clinical performance.
 To increase process capability
and reduce product variability
and defects by enhancing
product and process design,
understanding, and control.

4. Advantages Of QBD :-
 Higher level of assurance of drug
product quality.
 Offers cost savings and efficiency for
the pharmaceutical industry.
 Increases efficiency of pharmaceutical
manufacturing processes and reduces
manufacturing costs and product
rejects.
 It facilitates innovation for unmet
medical needs.
 Makes the scale-up, validation and
commercialization transparent,
rational and predictable

6. Quality Target Product Profile (QTPP)
 Necessary Elements
1. Quality characteristics: sterility, purity etc.
(including specific safety-related impurities where
necessary)
2. Pharmacokinetic characteristics: dissolution etc.
3. Therapeutic effect
4. Target patient population: neonate, adult etc.,
clinical diagnosis
5. Shelf life: temperature, light conditions etc.
 Desired Elements
1. Dosage form: liquid for injection, solid tablet etc.
2. Route of administration: oral, IV, IM, SC
3. Clinical setting: self or clinic administration
4. Primary/secondary packaging: glass or plastic
vial/syringe; blister packaging etc

7. The QTPP Leads to Critical Quality
Attribute (CQA) Definition
 Critical Quality Attribute (ICH Q8): “A property or characteristic that
when controlled within a defined limit, range, or distribution ensures the
desired product quality.”
 Potential CQAs are derived from the QTPP and guide product and process
development.
 CQAs are identified by quality risk management and experimentation to
determine the effect of variation on product quality.
 The CQA list can be dynamic and may be updated based on product and
process knowledge.

8. Process Performance Qualification
 Verification that the defined CS consistently delivers the desired product
quality
 PPQ is a significant product milestone
1. Provides proof the process is well controlled
2. Establishes an initial baseline for future process evaluation
 PPQ is a dynamic part of the validation concept

9. Risk assessment method
Quality risk management (QRM)
 FDA defines QRM as a systematic
process for the assessment, control,
communication and review of risks
to the quality of the drug product
across the product lifecycle.
 The goal of QRM is therefore to
identify risks within a process or
event, analyzing the significance of
these risks, and take appropriate
measures to mitigate such risks if
deemed unacceptable.

10. Various methods for determination of
risk
 There are various method for
determination of risk are as
follows :-
1. Failure mode effect analysis
2. Failure mode effect and
criticality analysis
3. Decision tree analysis
4. Hazards analysis & critical
control point
5. Hazard operability analysis
6. Preliminary hazard analysis
7. Risk ranking & filtering

11. Design Of Experiment
 DOE is an efficient procedure
for planning experiments so
that the data obtained can be
analyzed to yield valid and
objective conclusions.
 A structured, organized method
for determine the relationship
between factors affecting a
process and the output of that
process is known as “Design of
experiment”.

12. Application Of DOE
 DOE is used to :-
1. Determine the causes of
variation in the response
2. Find conditions under which
the optimal (maximum or
minimum) response is achieved
3. To compare responses at
different levels of controlled
variables
4. To develop a model for
predicting response.

13. Control Strategy
 Control strategy is defined as “a planned set of controls, derived
from current product and process understanding that assures process
performance and product quality”.
 The control strategy in the QbD paradigm is established via risk
assessment that takes into account the criticality of the CQA and
process capability.

14. Life Cycle Management
 According to Elaine Morefield (Deputy Director USFDA) it includes
continuous improvement of method performance and the design
space allows flexibility for continuous improvement in analytical
method can be done without prior regulatory approval because of
design space made previously.