Quality by Design (QbD) is a systematic approach in pharmaceutical development aimed at embedding quality from the outset, guided by scientific understanding and risk management. Key elements include defining quality target product profiles, identifying critical quality attributes, conducting risk assessments, and establishing control strategies. The benefits of implementing QbD include enhanced product quality, regulatory flexibility, cost savings, and improved risk mitigation.

1. Quality by Design
(QbD)
Quality Assurance
Ms. Jamdhade Ashwini A.
Assistant Professor
Sanjivani College of Pharmaceutical Education and Research, Kopargaon

2. Quality by Design (QbD): An Overview
• Definition: Quality by Design (QbD) is a systematic approach to pharmaceutical development that
focuses on building quality into products from the beginning. It is guided by scientific
understanding and risk management to ensure consistent product quality and performance.
• Brief Overview:
• QbD is based on International Council for Harmonization (ICH) guidelines: Q8(R2), Q9, and Q10.
• It involves proactive product design and process control.
• Focuses on understanding and mitigating risks to ensure quality.
• Benefits include improved product consistency, regulatory flexibility, and cost efficiency.

3. Key Elements of a QbD Program
1. Quality Target Product Profile (QTPP):
 Defines intended product characteristics (e.g., dosage form, route, and strength).
 A prospective summary of the quality characteristics of a drug product, defining its intended use,
performance, and safety.
 Examples: Dosage form, route of administration, strength, purity, and stability.
2. Critical Quality Attributes (CQAs):
 Attributes that impact product quality and performance (e.g., dissolution, sterility).
 Physical, chemical, biological, or microbiological properties of the drug that must be controlled to ensure
product quality.
 Examples: Content uniformity, dissolution rate, sterility, and assay.

4. Key Elements of a QbD Program
3. Risk Assessment:
 Identifies and evaluates potential risks using tools like FMEA. (Cause and Effect)
 Systematic identification, analysis, and mitigation of risks to product quality using tools like Failure
Mode and Effects Analysis (FMEA) or Fishbone diagrams.
 Includes Measurements, Material, People, Environment, Machine, Processes= Problem
4. Design of Experiments (DoE):
 Structured approach to studying variable impacts on CQAs.
 A structured approach to experiment planning that evaluates the impact of multiple variables on
CQAs.

5. Key Elements of a QbD Program
5. Critical Process Parameters (CPPs):
 Process parameters (e.g., mixing time, drying temperature, pH) that influence CQAs and must be
controlled to maintain quality.
 CPPs are identified through process development studies and risk assessments
 Examples:
o Compression force in tablet manufacturing
o Spray rate in granulation
o Flow rate in chromatography for purification

6. Key Elements of a QbD Program
6. Control Strategy:
 A planned set of controls to ensure that the product consistently meets CQAs.
 Provides confidence in product quality and reduces reliance on end-product testing.
 Activities:
o Raw material specifications
o Process controls (e.g., in-process testing)
o End-product testing
o Real-time monitoring (e.g., PAT tools)
7. Lifecycle Management:
 Continuous monitoring, evaluation, and improvement of the product and process throughout its lifecycle.
 Ensures sustained product quality and compliance with evolving regulatory expectations.
 Key Activities: Post-approval change management, Ongoing process verification, Continuous improvement based

7. Benefits of QbD
1. Enhanced Product Quality:
Ensures consistent performance and safety.
2. Regulatory Flexibility:
Facilitates easier process modifications.
3. Risk Mitigation:
Proactively identifies and resolves issues.
4. Cost Savings:
Reduces waste, rework, and failures.
5. Robust Processes:
Builds resilience into manufacturing systems.

8. Thank You