OPTIMIZING QUALITY BY DESIGN IN BULK POWDER & SOLID

DOSAGE
SMT.KISHORITAI BHOYAR COLLEGE OF PHARMACY,KAMTEE

INTRODUCTION
Pharmaceutical QBD is a systematic scientific risk based approach to
pharmaceutical development that begins with predefined objective
that address product & process understanding & process control.
Applying QBD principles leads to greater process understanding
facilitates regulatory approval & streamlines post approval changes.
Main step of a QBD process critical quality attributes (CQA).CQA are
defined based on the target drug profile these are quality characteristic of a
drug. ( eg. purity, crystalline form, particle size)
RISK ASSESSMENT
During the development phase for CQR, on analysis of the potential
critical process parameter & potential critical material attribute is
conducted.

Figure 1: An overview of Hoviones quality-by-design approach. CQA is
critical quality attribute, PAT is process analytical technology, NOR is
normal operating range, FMEA is failure mode effect analysis. All Figures are
courtesy of the authors.

Criticality analysis
By knowing the feasible operating region & after evaluating the equipment /procedure at the
manufacturing scale & the practical NOR, a final criticality analysis takes place to identify
parameter/material attributes that will require tight monitoring or control.

Process control strategy
Once the criticility around a process


Figure 2: Risk assessment. Decomposing the process in main steps for a
more structured criticality assessment (illustrative example for the bulk
powder manufacturing process). CQA is critical quality attribute, p is
potential.