This presentation introduces Quality by Design (QbD) for pharmaceutical formulation and development. QbD requires understanding how formulation and process variables impact product quality to ensure predefined quality. The benefits of QbD include eliminating batch failures, minimizing deviations, and avoiding regulatory issues. For formulation and development, QbD involves establishing a quality target product profile, identifying critical quality attributes, conducting a risk assessment of drug substance and formulation attributes, developing an initial formulation, using design of experiments for optimization, establishing a control strategy, conducting pilot bioequivalence studies, and scale up with supporting stability studies.

1. WELCOME TO MY PRESENTATION
Quality by Design (QbD) For Formulation And
Development
Presented by:-
SUHASINI . V
M.Pharm 1st year
(Pharmaceutics)

3. Ref.: ICH Q8 (R2)

4. SIGNIFICANCE OF QbD :
 Quality by Design means –designing and
developing formulations and manufacturing
processes to ensure a predefined quality
 Quality by Design requires – understanding how
formulation and manufacturing process variables
influence product quality .
 Quality by Design ensures – Product quality with
effective control strategy

6. 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

7. IMPORTABT OF OBD FOR FORMULATION
AND DEVELOPMENT
 Quality target product profile (QTPP)
 Critical quality attribute (CQAs)
 Initial risk assessment for drug substance attributes
 Initial risk assessment for drug formulation attributes
1. Selection of excipients
2. Excipients compatibility studies
3. Development of Q& Q formula for initial
formulation development

8.  Design development strategies
 DOE for optimization of formulation
 Initial risk assessment for manufacturing process
 Pilot bioequivalence studies
 Well defined control strategy
 Scale up from lab to pilot scale and then commercial
scale
 Container and closure system
 Development studies to be supported with stability
studies

13. Initial risk assessment for drug formulation
attributes

17.  “A planned set of controls, derived from current
product and process understanding that ensures
process performance and product quality…..”
ICH Q8 (R2) & Q10
Control Strategy includes following elements (but not
limited to):
 Input material attributes (e.g. drug substance, excipients,
container closure)
 Equipment operating conditions
 In-process controls
 Finished product specifications
 Controls for each unit operations
 Methods and frequency of monitoring and control.
Control Strategy

18. Pilot bioequivalence studies
 A pilot study in a small number of subjects can be
carried out before proceeding with a full
bioequivalence study.
 The study can be used to validate analytical
methodology, assess variability, optimize sample
collection time intervals, and provide other
information.
 Example : Pilot bioequivalence studies can help
determine the sampling schedule to assess lag time
and dose dumping.

19. Scale up from lab to pilot scale and
then commercial scale
 It is the part of the pharmaceutical industry where
a lab scale formula is transformed into a viable
product by development of liable practical
procedure of manufacturing.
 Evaluating the results of laboratory studies and
making product and process corrections and
improvements

20. Container and closure system
 Suitable container closure system to achieve the
target shelf life and to ensure product integrity
during shipping
 primary packaging components & secondary
packaging components, if the latter are intended to
provide additional protection to the drug product.
 Packaging aspects must be considered during the
development of product. The packaging process
parameters may affect the final product quality.

21. Development studies to be supported
with stability studies
 "…… to provide evidence on how the quality of a drug
substance or drug product varies with time under the
influence of a variety of environmental factors such as
temperature, humidity & light, & enables
recommended storage conditions, re-test periods &
shelf lives to be established”
1. Long Term
2. Intermediate
3. Accelerated

22. Advantages of QbD
 Benefits for Industry:
 Better understanding of the process.
 Less batch failure.
 More efficient and effective control
 Return on investment / cost savings.
 Allows for implementation of new technology to improve
manufacturing
 Improves interaction with FDA –deal on a science level instead of on a
process level
 Allows for continuous improvements in products and manufacturing
process.

23. 1. Guidance for Industry: Q8(R2) Pharmaceutical Development
2. Guidance for Industry: Q9 Quality Risk Management
3. Guidance for Industry: Q10 Pharmaceutical Quality System
4. http : // www.drug regulation .org