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Quality by Design

May 2013

Market/ Patient Needs Continual Improvement

Quality Target Product Profile (QTPP) Safety Efficacy Stability

Research / Clinical studies

Review (Change Controls)

Revalidation

QbD (Quality by Design)

Critical Quality Attributes (CQA) & Critical Material Attributes (CMA) Product Design
Materials (RMs, MOC, Critical Components) Equipment Design FMEA

Physical / Mechanical (Particle size, Hardness, etc.) Chemical Biological Microbiological

Commercial Manufacturing GMP Implementation

Yield, CP & CPk Safety Identity Strength Quality Purity

Process Design Control Strategy

Critical Process Parameters (CPP)

Design of Experiments (DOE) Methodology Measurements Process FMEA Process validations Quality Control Plan

Verification

Planning DOE

Technical & Regulations

Filing & Review Optimization

Screening/ Characterization

Ravi Kiran Muddha