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Quality by design

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mariapriyadarshini

The pharmaceutical Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance

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Schedule M SRI VENKATESHWARA COLLEGE OF PHARMACY
Contents Quality by Design Terminology Quality by Design- QbD development process include Quality by Design- Tools Quality by Design- Advantages Any Queries & Thanks Schedule M
Quality by Design Definition: The pharmaceutical Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance Schedule M
QbD development process include: Begin with a target product profile that describes the use, safety and efficacy of the product Define a target product quality profile that will be used by formulators and process engineers as a quantitative surrogate for aspects of clinical safety and efficacy during product development Gather relevant prior knowledge about the drug substance, potential excipients and process operations Schedule M Quality by Design
Quality by Design Design a formulation and identify the critical material (quality) attributes of the final product that must be controlled to meet the target product quality profile Design a manufacturing process to produce a final product having these critical material attributes. Continually monitor and update the process to assure consistent quality.
Design of experiments (DOE), risk assessment, and process analytical technology (PAT) are tools that may be used in the QbD process. Design of experiments (DOE): Branch of applied statistics deals with planning, conducting, analyzing and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of parameters. Schedule M Quality by Design
Quality by Design Risk assessment: The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk. Process Analytical Technology (PAT): Is a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).
Schedule M Quality by Design Advantages of QbD: Better understanding of the process. Less batch failure More efficient and effective control of change. More efficient technology transfer to manufacturing. Greater regulator confidence of robust products. Risk-based approach and identification. Innovative process validation approaches.
Quality by Design Less intense regulatory oversight and less post-approval submissions. For the consumer, greater drug consistency. More drug availability and less recall. Improved yields, lower cost, less investigations, reduced testing, etc.
QbD activities within FDA Specifically, the following activities are guiding the overall implementation of QbD: In FDAs Office of New Drug Quality Assessment (ONDQA), a new risk- based pharmaceutical quality assessment system (PQAS) was established based on the application of product and process understanding. Implementation of a pilot program to allow manufacturers in the pharmaceutical industry to submit information for a new drug application demonstrating use of QbD principles, product knowledge, and process understanding. In 2006, Merck & Co.s Januvia became the first product approved based upon such an application. Schedule M Quality by Design
Implementation of a Question-based Review (QbR) Process has occurred in CDERs Office of Generic Drugs. CDERs Office of Compliance has played an active role in complementing the QbD initiative by optimizing pre-approval inspectional processes to evaluate commercial process feasibility and determining if a state of process control is maintained throughout the lifecycle, in accord with the ICH Q10 lifecycle Quality System. Implementation of QbD for a Biologic License Application (BLA) is progressing. Schedule M Quality by Design
International Conference on Harmonization. (ICH) Relevant documents from the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. (ICH) Pharmaceutical Development Q8 (R2) Quality Risk Management Q9 Pharmaceutical Quality System Q10 Schedule M Quality by Design
Conclusion: Ensures robust commercial manufacturing methods for consistent production of quality drugs. Ensures the consumers that therapeutic equivalent generics are manufactured every single time. Offers the agency that quality applications are submitted to improve the review efficiency and to reduce the application approval times. QbD methodology helps in identifying and justifying target product profiles, product and process understanding. Helps in continuous improvement. There is a need for vigorous and well funded research programs to develop new pharmaceutical manufacturing platforms. Schedule M Quality by Design

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Quality by design

  • 1. Schedule M SRI VENKATESHWARA COLLEGE OF PHARMACY
  • 2. Contents Quality by Design Terminology Quality by Design- QbD development process include Quality by Design- Tools Quality by Design- Advantages Any Queries & Thanks Schedule M
  • 3. Quality by Design Definition: The pharmaceutical Quality by Design is a systematic approach to development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. Quality by Design is emerging to enhance the assurance of safe, effective drug supply to the consumer, and also offers promise to significantly improve manufacturing quality performance Schedule M
  • 4. QbD development process include: Begin with a target product profile that describes the use, safety and efficacy of the product Define a target product quality profile that will be used by formulators and process engineers as a quantitative surrogate for aspects of clinical safety and efficacy during product development Gather relevant prior knowledge about the drug substance, potential excipients and process operations Schedule M Quality by Design
  • 5. Quality by Design Design a formulation and identify the critical material (quality) attributes of the final product that must be controlled to meet the target product quality profile Design a manufacturing process to produce a final product having these critical material attributes. Continually monitor and update the process to assure consistent quality.
  • 6. Design of experiments (DOE), risk assessment, and process analytical technology (PAT) are tools that may be used in the QbD process. Design of experiments (DOE): Branch of applied statistics deals with planning, conducting, analyzing and interpreting controlled tests to evaluate the factors that control the value of a parameter or group of parameters. Schedule M Quality by Design
  • 7. Quality by Design Risk assessment: The systematic application of quality management policies, procedures, and practices to the tasks of assessing, controlling, communicating and reviewing risk. Process Analytical Technology (PAT): Is a mechanism to design, analyze, and control pharmaceutical manufacturing processes through the measurement of Critical Process Parameters (CPP) which affect Critical Quality Attributes (CQA).
  • 8. Schedule M Quality by Design Advantages of QbD: Better understanding of the process. Less batch failure More efficient and effective control of change. More efficient technology transfer to manufacturing. Greater regulator confidence of robust products. Risk-based approach and identification. Innovative process validation approaches.
  • 9. Quality by Design Less intense regulatory oversight and less post-approval submissions. For the consumer, greater drug consistency. More drug availability and less recall. Improved yields, lower cost, less investigations, reduced testing, etc.
  • 10. QbD activities within FDA Specifically, the following activities are guiding the overall implementation of QbD: In FDAs Office of New Drug Quality Assessment (ONDQA), a new risk- based pharmaceutical quality assessment system (PQAS) was established based on the application of product and process understanding. Implementation of a pilot program to allow manufacturers in the pharmaceutical industry to submit information for a new drug application demonstrating use of QbD principles, product knowledge, and process understanding. In 2006, Merck & Co.s Januvia became the first product approved based upon such an application. Schedule M Quality by Design
  • 11. Implementation of a Question-based Review (QbR) Process has occurred in CDERs Office of Generic Drugs. CDERs Office of Compliance has played an active role in complementing the QbD initiative by optimizing pre-approval inspectional processes to evaluate commercial process feasibility and determining if a state of process control is maintained throughout the lifecycle, in accord with the ICH Q10 lifecycle Quality System. Implementation of QbD for a Biologic License Application (BLA) is progressing. Schedule M Quality by Design
  • 12. International Conference on Harmonization. (ICH) Relevant documents from the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. (ICH) Pharmaceutical Development Q8 (R2) Quality Risk Management Q9 Pharmaceutical Quality System Q10 Schedule M Quality by Design
  • 13. Conclusion: Ensures robust commercial manufacturing methods for consistent production of quality drugs. Ensures the consumers that therapeutic equivalent generics are manufactured every single time. Offers the agency that quality applications are submitted to improve the review efficiency and to reduce the application approval times. QbD methodology helps in identifying and justifying target product profiles, product and process understanding. Helps in continuous improvement. There is a need for vigorous and well funded research programs to develop new pharmaceutical manufacturing platforms. Schedule M Quality by Design