Quality by design, QBD

1. Quality Assurance and Quality Management concepts
BP606T
Unit-1
Part-IV
(QUALITY BY DESIGN (QBD): DEFINITION, OVERVIEW, ELEMENTS OF
QBD PROGRAM, TOOLS )
Snigdha Rani Behera
Associate Professor
ARKA JAIN UNIVERSITY

2. QUALITY BY DESIGN (QBD)
Definition:
 Quality by design (QbD) is a systematic approach to product development that
begins with predefined objectives and emphasizes product and process
understanding and controls based on sound science and quality risk management
(ICH Q8).
 QbD is a concept first developed by the quality pioneer Dr. Joseph M. Juran. He
belived that quality should be designed into a product, and that most quality crises
and problems relate to the way in which a product was designed in the first place.
ARKA JAIN University, Jamshedpur, Jharkhand

3. ARKA JAIN University, Jamshedpur, Jharkhand
Objective of QbD:
 The main objective of QbD is to achieve the quality products.
 To achieve positive performance testing.
 Ensures combination of product and process knowledge gained during
development.
 From knowledge of data process desired attributes may be constructed.
Benefits of QBD:
 Better understanding of the process.
 Eliminate batch failures.
 More efficient and effective control of change.
 Avoid regulatory compliance problems.
 Empowerment of technical staff.
 Increase manufacturing efficiency, reduce costs and Project rejections and waste.

4. ARKA JAIN University, Jamshedpur, Jharkhand
Cont…..
 Ensure better design of product with less problem.
 Build scientific knowledge base for all products.
 Better interact with industry on science issues.
 Ensure consistent information.
 Incorporate risk management.
 Reduce end-product testing.

5. Flow of QbD
ARKA JAIN University, Jamshedpur, Jharkhand
Define Target product profile (TPP) and Quality
Target Product profile (QTPP)
Identify critical quality attributes (CQA)
Carry out risk assessment, linking material
attributes and process parameters
Establish the design space
Describe control strategy
Life cycle management and continuous
improvement

6. ELEMENTS OF QBD PROGRAM
ARKA JAIN University, Jamshedpur, Jharkhand
Target
product
Profile(TPP) Target product
Quality Profile
(TPQP)
Critical Quality
Attributes
(CQAs)
Critical
Material
attributes
(CMAs)
Process
Parameters
(PP)
Design Space
(DS)
Key Element
of QBD

7. 1.Target product Profile(TPP):
 It is a theory based on Patient and Labeling. (Because it identifies the desired
performance characteristics of the product, related to the patient’s need & it is
organized according to the key section in the drug labeling)
Target product profile should includes-
 Dosage form
 Route of administration
 Dosage strength
 Pharmacokinetics
 Stability
 Target number of Patients
ARKA JAIN University, Jamshedpur, Jharkhand

8. 2.Target product Quality Profile(TPQP):
 It is a Prospective and dynamic review of quality characteristics of a drug product.
 It can be achieved to ensure that the desired quality, safety & efficacy of a drug
product are achieved.
 It include Quantitative impurity and stability targets, Dissolution release profile,
identity, assay, dosage form product specific performance.
ARKA JAIN University, Jamshedpur, Jharkhand

9. 3.Critical Quality Attributes (CQAs):
 It is defined as “a physical, chemical, biological or microbiological property or
characteristics 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
and drug product.
 The quality attributes of a drug product may include identity, assay, content
uniformity, degradation products, residual solvents, drug release, moisture
content, microbial limits.
 Physical attributes such as color, shape, size, odor, score configuration, and
friability.
 These attributes can be critical or not critical.
ARKA JAIN University, Jamshedpur, Jharkhand

10. 4. Critical Material Attributes (CMA):
 CMA of a drug substance, excipient, and in-process materials is a physical,
chemical, biological, or microbiological characteristic of an raw material that
should be consistently within an appropriate limit to ensure the desired quality of
that drug substance, excipient, or in-process material.
 The CMA is likely to have an impact on CQA of the drug product.
 A material attributes can be an excipients raw material, drug substances, reagents,
solvents, packaging & labeling materials.
ARKA JAIN University, Jamshedpur, Jharkhand

11. 5. Critical Process Parameters (CPP):
 A CPP of manufacturing process are the parameters which, when changed, can
potentially impact product CQA and may result in failure to meet the limit of the
CQA.
 This is depend on operational parameter of a system or unit operation.(Mixing
speed, flow rate, mobile phase ratio, molarity of buffer, pH of buffer) and process
state variables (Temp, Pressure, viscosity, density, angle of repose)
ARKA JAIN University, Jamshedpur, Jharkhand

12. 6. Design Space (DS):
 As per ICH Q8- This is the multidimensional combination and interaction of input
variables (e.g., material attributes) and process parameters that have been
demonstrated to provide assurance of quality.
 A design space may be built for a single unit operation or for the ensure process.
ARKA JAIN University, Jamshedpur, Jharkhand

13. ARKA JAIN University, Jamshedpur, Jharkhand
Tools of QBD
2. Risk assessment
methodology
3. Process Analytical
Technology
1. Design of
Experiment (DoE)
Tools of QBD

14. 1. Design of Experiment (DoE):
 A structured, organized method for determining the relationship between factors
affecting a process and the output of that process is known as “Design of
Experiments”.
 This is a systematic approach applied to conduct experiments to obtain
maximum output according to a pre-specified design.
 It can help identify optimal conditions, CMAs, CPPs and ultimately the Design
Space.
 We have capability and expertize to perform DoE in product development using
software like Minitab and Statistica, Stat-Ease.
ARKA JAIN University, Jamshedpur, Jharkhand

15. 1. Risk Assessment Methodology:
 It is a systematic process of organizing information to support a risk decision to
be made with in a risk management process.
 Next steps of quality risk management process is risk control, risk review.
 There are three components of Risk assessment method. i. e. Risk
identification, Risk analysis, Risk evaluation.
ARKA JAIN University, Jamshedpur, Jharkhand

16. 3. Process Analytical Technique (PAT):
 It is defined as “Tools and systems that utilize real time measurements or rapid
measurement during processing, of evolving quality and performance attributes of
in process materials to provide information to ensure optimal processing to
produce final product that consistently conforms to established quality and
performance standards”.
 In Q8 Guidelines the use of PAT to ensure the process remains in an established
Design Space.
 There are three step process in PAT i.e. design, analyze, control.
ARKA JAIN University, Jamshedpur, Jharkhand

17. THANK YOU
STAY SAFE
&
STAY HEALTHY
ARKA JAIN University, Jamshedpur, Jharkhand