This document summarizes key concepts in quality by design (QbD) for pharmaceutical product and process development. It discusses that QbD is a systematic approach that begins with predefined quality targets and uses product and process understanding to establish design space and process controls. The document outlines critical elements of QbD including quality target product profile, critical quality attributes, critical material attributes, critical process parameters, design space, risk assessment, and design of experiments. It provides examples of each element and explains how they guide development and ensure quality.

1. Guided By: Smt. A.R. Dhole
Presented By: Tanaya Balasaheb Pawar
M.Pharm 1st year (Quality Assurance)
2019-20
Rajarambapu College of Pharmacy, Kasegaon
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2.  Before QbD the term QbT (Quality by Test)
is used .
 QbT involve testing of raw materials,( raw
material includes drug substance and drug
product) IPQC, end product , manufacturing
process.
 QbT is replace by QbD because:
 Small amount of sample tested in large batch.
 It was only way to maintain the quality.
 It is unsystemic way to maintain the quality.
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3.  Defination:
According to ICH guideline Q8 QbD is systematic
approach to develop that begins with predefined
objectives that product and process understanding
and process control based on sound science and
quality risk management.
 During the study of formulation by design and
QbD for drug product following points should be
consider:
1. Quality Target Product Profile (QTPP)
2. Critical Quality Attribute (CQA)
3. Critical Material Attribute (CMA)
4. Critical Process Parameter (CPP)
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4. 5. Design Space
6. Design of Experiment.
7. Risk Assessment
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5.  It is related to the safety and efficacy.
 It includes route of administration, dosage form,
delivery system, strength, container closure system,
pharmacokinetic parameters.
 It include drug product quality criteria i.e. sterility,
purity, stability, drug release.
 Simply QTPP is related to the consumer and label.
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6.  It includes physical, chemical, biological,
microbiological property that should be within
appropriate limit, range and ensure desired product
quality.
 CQA is a part of QTPP.
 Assay, dissolution, content uniformity includes in
both QTPP and CQA.
 It guide product and process development.
 It includes quality, safety, efficacy, properties of raw
materials that affect drug product performance.
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7.  We can identify CQA from QRM, literature
review, raw materials test data, recalls.
 It includes critical material attribute (CMA)
and critical process parameter (CPP).
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8.  Material includes raw material, starting
material, reagent, solvent, process aid,
intermediate product, API, packaging, labelling
material.
 Material attribute include physical, chemical,
biological, microbiological property.
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9.  It monitor , control and ensure that process
produces desire quality of product.
 Process parameter contains variability that
impact on critical quality attribute.
 Critical process parameter include
temperature, agitation rate, cooling rate,
rotation speed, pH, addition rate, dissolved
oxygen, feed type and feed rate.
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10.  It apply over product life cycle.
 It contain 6 tools which are given as follow
1. Failure Mode Effective Analysis (FMEA):
It is most commonly used.
It identify and analyse failure in process.
It includes error or defect in process, material
design, equipment.
To avoid failure perform risk control activities.
It breakdown large complex processes into
manageable steps.
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11. 2. Fault Tree Analysis (FTA) :
Tree of failure modes combinations with logical
operators.
3. Failure Mode Effects and Criticality Analysis (
FMECA):
FMEA and links severity, probability and detectability to
criticality.
4. Hazard Analysis and Critical Control Points (HACCP):
Systematic, proactive and preventive method of criticality.
5. Hazard Operability Analysis (HAZOP).
6. Preliminary Hazard Analysis (PHA).
7. Risk Ranking and Filtering :
Compare and prioritize risks with factors for each risk.
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12. 
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13.  It is multidimensional combination and interaction of input
variables and process parameter that have been demonstrate
that to provide quality.
 It includes study of all effects one by one by varying all
parameters simultaneously and understand interaction
between several variables.
1) Define range input and output variables.
2) Select experimental design and perform to run
3) Model diagnostic
It decide starting model and verify that model appropriate or
not.
Verify importance of parameter and state procedure
Decide any add or remove from the cycle.
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14. 4) Illustration of design space:
Design space represented by table or graph.
Graphically it is illustrated by counter ploy, 3D
plot , overlay plot.
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16.  THANK YOU
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