The document outlines the key steps in a Quality by Design (QbD) approach including identifying critical quality attributes and critical process parameters, developing a design space that mathematically expresses their relationship, designing and implementing a control strategy, continually improving the product lifecycle through risk assessment and management, and developing a robust process to monitor critical quality attributes and adjust critical process parameters accordingly.

1. QTPP(Quality target product profile) relating to
Quality , safety, efficacy of the product
Identification of critical quality attributes
(CQAs)
Identification of critical product
attributes (CPPs)
Design development product/process
Understand and express mathematically
CQAs & CPPs relationship
Develop a design space
Design & implement control strategy
Product specification is based on understanding
of product formulation and performance
variables impact process performance
Continual improvement of the
product lifecycle
Risk review
quality
management
Initial risk
assessment
Risk assessment
Using prior
knowledge, risk
management tool,
DOE, Multivariate
analysis, etc.
Risk
control
Robust
process is
developed
Design process
measurement to allow
in-line, on-line, at-line
monitoring of CQAs
CPPs are adjusted by
measuring CQAs
QbD approach, combining design space development and risk management tools