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21 Feb 2024

What is Quality by Design (QbD)?

The pharmaceutical Quality by Design (QbD) 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.

QbD stands for Quality by Design, and it’s a systematic approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding and process control, based on sound science and quality risk management. In simpler terms, QbD is about building quality into the product from the very beginning, rather than just testing for it at the end.

QbD involves identifying critical quality attributes (CQAs) of the drug product, understanding how various factors affect these attributes, and designing a manufacturing process that ensures these attributes are consistently met within predefined limits. This approach helps to minimize variability, reduce manufacturing failures, and improve overall product quality and patient safety.

By implementing QbD principles, pharmaceutical companies can achieve more efficient and cost-effective drug development, as well as greater regulatory compliance and faster time to market for their products.

Objectives of QbD

  • To achieve meaningful product quality specifications that are based on clinical performance
  • To increase process capability and reduce product variability and defects by enhancing product and process design, understanding, and control
  • To increase product development and manufacturing efficiencies
  • To enhance root cause analysis and postapproval change management

QbD approach in pharmaceutical industry

In a pharmaceutical QbD approach to product development, an applicant identifies characteristics that are critical to quality from the patient’s perspective, translates them into the drug product critical quality attributes (CQAs), and establishes the relationship between formulation/manufacturing variables and CQAs to consistently deliver a drug product with such CQAs to the patient. QbD consists of the following elements:

  • A quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product
  • Product design and understanding including the identification of critical material attributes (CMAs)
  • Process design and understanding including the identification of critical process parameters (CPPs) and a thorough understanding of scale-up principles, linking CMAs and CPPs to CQAs
  • A control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process
  • Process capability and continual improvement

Example of QbD Principle in Pharmaceutical Domain

Let’s take the example of developing a tablet formulation for a new medication. In a traditional approach, a pharmaceutical company might focus primarily on testing the final product to ensure it meets quality standards. However, with QbD principles, the development process would be more comprehensive and systematic.

  1. Defining Objectives: The first step would be to define the objectives of the formulation, such as the desired release profile of the drug, stability requirements, and patient acceptability factors like taste and ease of swallowing.
  2. Identifying Critical Quality Attributes (CQAs): CQAs are the key characteristics that must be controlled within predefined limits to ensure the product meets its intended quality standards. For a tablet formulation, CQAs might include drug potency, dissolution rate, hardness, and content uniformity.
  3. Understanding the Impact of Variables: Next, the company would systematically study how various factors, such as raw material properties, manufacturing processes, and environmental conditions, affect the CQAs. This might involve experiments, simulations, and statistical analyses.
  4. Designing the Formulation and Process: Based on this understanding, the company would design the formulation and manufacturing process to minimize variability and ensure consistent quality. For example, they might choose specific excipients and processing techniques to optimize drug release and ensure uniformity.
  5. Implementing Control Strategies: Throughout development and production, the company would implement control strategies to monitor and adjust critical parameters, ensuring that the product consistently meets its quality targets. This might involve in-process testing, real-time monitoring, and feedback control loops.
  6. Continual Improvement: Finally, the company would continuously evaluate and improve the formulation and process based on new data and insights, ensuring ongoing optimization and compliance with quality standards.

By following these steps, the pharmaceutical company can develop a tablet formulation that not only meets regulatory requirements but also delivers consistent quality, efficacy, and safety to patients. Additionally, the company can potentially reduce development time and costs by identifying and addressing quality-related issues early in the process.

Conclusion

The goals of implementing pharmaceutical QbD are to reduce product variability and defects, thereby enhancing product development and manufacturing efficiencies and postapproval change management. It is achieved by designing a robust formulation and manufacturing process and establishing clinically relevant specifications. The key elements of pharmaceutical QbD can include the QTPP, product design and understanding, process design and understanding, and scale up, control strategy, and continual improvement. Prior knowledge, risk assessment, DoE, and PAT are tools to facilitate QbD implementation. Finally, product and process capability is assessed and continually improved postapproval during product lifecycle management.

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