Quality by desigh.pptx Pharmaceutics Gandaki university Sandesh Sharma

Quality by desigh.pptx QbD Element Benifit of Pharmaceutics Gandaki university Sandesh Sharma

1. Quality by desigh Pharmaceutics presentation Sandesh Sharma Gandaki university First semester

2. Overview Introduction Principles Elements Practical Implementation of QbD Principles B enefits challenges implementation strategies Applications References.

3. Introduction Quality by Design ( QbD ) is a systematic approach to pharmaceutical development that emphasizes the design of quality into the product from the beginning, rather than simply testing quality into the product after it has been manufactured.[ICH Q8guideline] QbD is a framework that enables pharmaceutical companies to build quality into their processes, which can lead to improved efficiency, reduced costs, and increased patient safety.[Ref.1] A key assertion of QbD is that quality is controlled not by simply testing the product, but rather by building quality into the manufacturing process by design. This is achieved by a control strategy that is based on both product and process understanding Quality by design ( QbD ) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design.[Ref.2]

4. Principles of QbD Defining the product quality profile: This involves identifying the CQAs of the product, which are the physical, chemical, biological, or microbiological properties or characteristics that are critical to the product's safety, efficacy, or quality. Designing the manufacturing process: Once the CQAs have been identified, the next step is to design a manufacturing process that can consistently produce a product with the desired quality attributes. This involves identifying the critical process parameters (CPPs) that can affect the CQAs and using this knowledge to design an optimal manufacturing process. Understanding the process: The next step is to develop a comprehensive understanding of the manufacturing process and the relationship between the CPPs and the CQAs. This involves conducting experiments and analyzing data to determine the effect of each process parameter on the product quality.

5. Controlling the process: Once the process has been designed and characterized, the next step is to implement process controls that can ensure the product is consistently produced with the desired quality attributes. This involves monitoring the CPPs, using real-time process monitoring and control systems, and using statistical process control methods to identify and address process variability. Continual improvement: Finally, QbD emphasizes the importance of continual improvement, using data and feedback from the manufacturing process to identify areas for improvement and to optimize the process further.

6. Elements Risk assessment: QbD involves a systematic approach to risk assessment, which includes identifying and assessing potential risks to product quality and patient safety throughout the product lifecycle. Design of experiments (DOE): DOE is a statistical method used to systematically explore and optimize the relationship between the CPPs and the CQAs. Process analytical technology (PAT): PAT is a set of tools and techniques used to monitor and control the manufacturing process in real-time, using data from in-process testing and measurements. Quality control (QC): QC involves testing the product at various stages of the manufacturing process to ensure it meets the desired quality attributes. Continuous improvement: QbD emphasizes the importance of continuous improvement, using data and feedback from the manufacturing process to identify areas for improvement and to optimize the process further.

7. Product quality profile Critical quality attributes (CQAs): These are the physical, chemical, biological, or microbiological properties or characteristics of the drug product that are critical to its safety, efficacy, and quality. CQAs may include properties such as potency, purity, stability, dissolution, particle size, and moisture content. Acceptance criteria: These are the quantitative or qualitative limits that define the acceptable range for each CQA. Acceptance criteria are typically based on regulatory requirements and scientific knowledge and may be different for different stages of the product lifecycle. Product specifications: These are the set of tests, methods, and procedures used to determine whether the drug product meets the acceptance criteria for each CQA. Product specifications may include tests for physical, chemical, biological, or microbiological properties. Manufacturing process parameters: These are the critical process parameters (CPPs) that can affect the CQAs of the drug product. Understanding the relationship between CPPs and CQAs is essential for designing a manufacturing process that can consistently produce a product with the desired quality attributes. Analytical methods: These are the methods used to test and measure the CQAs of the drug product. Analytical methods must be validated to ensure they are reliable, accurate, and precise.

8. Practical Implementation of QbD Principles Quality-by-Design implementation is facilitated in Stage 1 (Process Design) of the Process Validation Lifecycle. Within this workflow, there are multiple risk assessments and deliverables that should be met to develop a robust process and analytical control strategy. They are:

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10. These deliverables and risk assessments: form the basis of the design of the product; establish critical quality attributes (CQAs) and process performance indicators (PPIs); identify process parameters, material attributes, and raw materials with potential impact on CQAs and PPIs; and ultimately classify process parameters, material attributes, and raw materials as critical or non-critical. All together, these items coalesce to create a comprehensive control strategy for the lifecycle of a product. A comprehensive control strategy derived from current product and process understanding assures process performance and consistent, quality production.

11. Approaches to pharmaceutical development Table: Approaches to pharmaceutical development [Ref: Table.1]

12. Benefits of QbD QbD offers several benefits to pharmaceutical companies, including: Improved product quality and consistency Increased efficiency and reduced costs Enhanced understanding of the product and manufacturing process Improved risk management Improved regulatory compliance Increased patient safety and efficacy

13. Challenges of QbD Despite its many benefits, implementing QbD can be challenging. Some of the key challenges include: Cost: QbD requires significant investment in personnel, equipment, and resources. Time: QbD can add significant time to the development and manufacturing process. Knowledge and expertise: QbD requires specialized knowledge and expertise in statistical methods and risk assessment. Cultural barriers: QbD requires a culture of continuous improvement and a willingness to embrace change, which can be challenging to achieve in some organizations.

14. Implementation Strategies There are several strategies that pharmaceutical companies can use to implement QbD successfully: Develop a QbD strategy: Establish a clear strategy for implementing QbD , including goals, timelines, and resources required. Develop a team: Establish a cross-functional team with expertise in statistics, risk assessment, and quality management. Identify critical quality attributes (CQAs): Identify the CQAs that are most important to patient safety and efficacy. Identify critical process parameters (CPPs): Identify the process parameters that are most likely to impact product quality.

15. Applications Table : Applications of QbD in pharmaceutical unit operations and dosage forms. [Ref: Table.2]

16. References Ref 1 : QUALITY BY DESIGN | PharmaTutor Ref 2: Juran , J.M. (1992). Juran on Quality by Design: The New Steps for Planning Quality into Goods and Services. Free Press. Ref 3: URL: Principles of Quality-by-Design in Pharmaceutical Development | ICQ (icqconsultants.com) Table.1: Approaches to pharmaceutical development table - Bing images Table.2: Application of quality by design in the current drug development - ScienceDirect