Quality by design ( QbD)

Presentation On – Quality by Design(QbD)

Submitted By
Md. Husain Bin Siddiqui
UG08-20-12-002
State University of Bangladesh
20th Batch

Submitted To
Md.Saiful Islam Pathan
Associate Professor
State University of Bangladesh

Quality
The suitability of either a drug substance or a
drug product for its intended use. This term
includes such attributes as the identity,
strength, and purity .

Quality by Design
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

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

QbD frame (in ICH docs)
 The QbD frame contains concepts and tools - e.g.
design space - to practice QbD in a submission file (
design space approval ).
 The selection of QbD implies the use of Quality Risk
Management (ref.: ICH 9, Quality Risk Management) .
 The connection to a suitable (bio)pharmaceutical
quality system offers opportunities to enhance
science ad risk based submissions approaches

Quality by Design approach
can be used for
 Active pharmaceutical
ingredients
 Materials including
excipients
 Analytics
 Simple dosage forms
 Advanced drug delivery
systems
 Devices
 Combination products
(e.g. theranostics)

What are the steps in a
Quality by Design approach?
2. CRITICAL
QUALITY
ATTRIBUTES
3. LINK
MAs AND PPs
TO CQAS
4. ESTABLISH
DESIGN
SPACE
1. TARGET
PRODUCT
PROFILE
5. ESTABLISH
CONTROL
STRATEGY
6. Risk
Assessment

Target Product Quality Profile
• The target product profile (TPP) has been defined as
a “prospective and dynamic summary of the quality
characteristics of a drug product that ideally will be
achieved to ensure that the desired quality, and thus
the safety and efficacy , of a drug product is realized”.

Critical Quality Attributes
 A CQA is 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.
 CQAs are generally associated with the
• Drug substance,
• Excipients,
• Intermediates (in-process materials) and
• Drug product.

Material attribute
Material:
• Raw materials, starting materials, reagents, solvents, process aids,
intermediates, apis, and packaging and labelling materials, ICH Q7A
Attribute:
• A physical, chemical, biological or microbiological property or
characteristic
Material attribute:
• Can be an excipient CQA, raw material CQA, starting material CQA,
drug substance CQA etc
• A material attribute can be quantified
• Typically fixed
• can sometimes be changed during further processing (e.G. PSD–
milling)
• Examples of material attributes: PSD, impurity profile, porosity,
specific volume, moisture level, sterility.

Process Parameter
 A process parameter whose variability has an impact on a
critical quality attribute and therefore should be monitored or
controlled to ensure the process produces the desired quality
(Q8R2)
 CPPs have a direct impact on the CQAs
 A process parameter (PP) can be measured and controlled
(adjusted)
 Examples of CPPs for small molecule: Temperature,
addition rate, cooling rate, rotation speed
 Examples of CPPs for large molecule: Temperature, pH,
Agitation, Dissolved oxygen, Medium constituents, Feed type
and rate

Design Space
Definition
The multidimensional combination and interaction of input
variables (e.g., material attributes) and process
parameters that have beendemonstrated to provide
assurance of quality
 Regulatory flexibility
Working within the design space is not considered a change
 Important to note
Design space is proposed by the applicant and is subject to
regulatory assessment and approval

Design Space Determination
 First-principles approach
◦ Combination of experimental data and mechanistic knowledge of
chemistry, physics, and engineering to model and predict
performance
 Non-mechanistic/empirical approach
◦ statistically designed experiments (does) ◦ linear and multiple-linear
regression
 Scale-up correlations
◦ Translate operating conditions between different scales or pieces of
equipment
 Risk analysis
◦ Determine significance of effects
 any combination of the above

Control Strategy
A planned set of controls,
o Derived from current product and process understanding,
o That assures process performance and product quality.
The controls can include
Parameters and attributes related to
o Drug substance
o Drug product materials
o Components, facility
o equipment operating conditions
o In-process controls
o Finished product specifications, and
o The associated methods and frequency of monitoring and control
(ICH 10)

Risk Assessment
• Risk assessment : Risk is defined as the combination
of the probability of occurrence of harm and the
severity of that harm.
• Risk Assessment – A systematic process of organizing
information to support a risk decision to be made
within a risk management process. It consists of the
identification of hazards and the analysis and
evaluation of risks associated with exposure to those
hazards.

Conclusion
• Quality by Design define target product quality
profile ,design and develop formulation and process
to meet target product quality profile, Identify critical
raw material attributes, process parameters, and
sources of variability. PAT, DoE, and risk assessment
are tools to facilitate the implementation of QbD.
There is a need for vigorous and well funded
research programs to develop new pharmaceutical
manufacturing platforms.

References
• [1] ICH Guideline Q8 – Pharmaceutical Development,
http://www.ich.org (10 Nov 2005).
• [2] U.S. Food and Drug Administration Guidance for Industry. PAT –
A Framework for Innovative.
• [3] J.C. Berridge An Update on ICH Guideline Q8 – Pharmaceutical
Development, www.fda.gov/ohrms/dockets/AC/06/ slides/2006-
4241s1_2.ppt, ISPE Vienna Congress 2006.

References(PPT)
• Quality by Design (QbD) (Power point) by N. Vidyashankar
12.1.2012
• GMP for the 21st Century: GMP (power point) by jwdorpema,
leiden.10.11.2010

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