Quality By Design Introduction:
Table of Contents
Pharmaceutical industries always rely on continuous improvement in the safety, quality, and efficacy of the products. The pharmaceutical products are intended for patient care. So, the priority is enhanced therapeutic benefits and the absence of impurities. Therefore, the product should be designed to meet patients’ needs and the intended product performance. The product quality and performance are regulated by finished product testing, with an understanding of the process and critical process parameters. The US FDA (Food and Drug Administration) has adopted the principles of Quality By Design (QbD) in the development, manufacturing, and regulation of pharmaceutical products. ICH guidelines also focus on the principles of QbD through its guidelines mentioned as ICH Q8 (R2)- Pharmaceutical Development, ICH Q9 (Quality Risk Management), ICH Q10 (Pharmaceutical Quality System), and ICH Q11 (Development and manufacture of drug substances).
According to US FDA and ICH Q8 (R2), the QbD is a systematic approach to development that includes the prior knowledge of product and process understanding based on the results of studies using design of experiments, use of quality risk management, and use of knowledge management.
Objectives of Quality By Design:
The main objectives of QbD are as follows:
1. Increasing manufacturing efficiency.
2. Increasing the efficiency in product development.
3. Enhancement of product quality and performance to meet patients’ needs.
4. Increase in process capability.
5. Avoidance of regulatory compliances.
6. Incorporation of risk management.
7. Reduction in production costs and waste.
8. Reduction in product variability, defects, and rejections.
The main outcomes of QbD are as follows:
1. Maintenance of product quality to meet expected clinical performances.
2. Maintenance of product quality by efficient manufacturing and formulation process.
Elements of Quality By Design:
The following elements can be included in the study of QbD:
1. QTPP (Quality Target Product Profile): This profile is related to quality, safety, and efficacy.
2. CQAs (Critical Quality Attributes): The study of CQAs helps in the study and controlling of the product characteristics that have an impact on product quality.
3. Determination of CQAs of drug substances, excipients, etc., and the selection of the excipients to attain the desired drug quality.
4. Suitable manufacturing process selection.
5. Risk assessment:
- CMAs (Critical Material Attributes)
- CPPs (Critical Process Parameters)
6. Defining a control strategy.
Quality Target Product Profile (QTPP)
1. Dosage forms, route of administration, delivery systems.
2. Strength of doses.
3. Container closure system.
4. Pharmacokinetic properties.
5. Drug product quality criteria.
Critical Quality Attributes (CQA)
CQA is related to drug substances, excipients, intermediates (in-process materials), and drug products. CQA is a physical, chemical, biological, or microbiological property (should be within an appropriate limit, range, or distribution) to ensure the desired product quality.
Risk Assessment: CMAs (Critical Material Attributes) and CPPs (Critical Process Parameters)
Risk assessment, a science-based method or process, is used in QRM (Quality Risk Management, mentioned in ICH Q9). This assessment identifies materials attributes and process parameters effectively that affect product CQAs. This process is utilized in the prior pharmaceutical development process which makes available more information and knowledge about the development process. Based on prior knowledge and initial experimental data, the risk assessment method helps to identify and rank different parameters like process, equipment, and input materials with the potential that have an impact on product quality.
The pharmaceutical product should be produced with the required quality inconsistent fashion and the control strategy ensures this. It includes the following elements:
1. Control of input material attributes viz., drug substance, excipients, packaging materials, considering their utilization and effect on product quality.
2. Product specifications.
3. Controls of unit operations that have a role to maintain the product quality. The operations may include granulation, drying, degradation, particle size distribution, etc.
4. In-process testing.
5. Finished product testing.
6. Testing of products at every stage at regular intervals (Monitoring program).
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