Quality by Design Course

Quality by Design (QbD)

As stated in Q8, the ICH guidance document on pharmaceutical development, drug product should meet its intended product performance as well as meet the needs of patients. Although the strategy for pharmaceutical development may vary from company-to-company and/or from product-to-product, a systematic approach defined by quality by design (QbD) principles is required. Further guidance and policies have been provided to explain how the QbD approach should be integrated into the pharmaceutical quality system including process design, qualification, continued process verification, risk management, and validation. Although guidance on implementation of these requirements is prevalent, many companies have not yet implemented QbD into their quality systems; regulatory agencies have made it clear this will change. In fact, the chemistry, manufacturing, and controls (CMC) reviewers in the Office of Pharmaceutical Science (OPS) recently released a manual on policies and procedures (MAPP) explaining how reviewers will begin to enforce the requirements from these guidance documents.

This course will demonstrate how you can efficiently integrate QbD principles into your pharmaceutical quality system to achieve the desired results:

– Compliance with current regulatory guidance
– Enhanced knowledge of product performance and process variation
– Flexible regulatory approaches
– A basis for risk management, process validation, and a control strategy resulting in a product with the desired quality

Course description:

This course focuses establishing a systematic approach to pharmaceutical development defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents.

Learn how to:

  • Implement QbD principles from discovery through product discontinuation
  • Apply statistics to set specifications and validate measurement systems (assays)
  • Utilize risk management tools to identify and prioritize potential critical process parameters
  • Identify critical process parameters and develop a functional relationship between those process parameters and your critical-to-quality attributes (CQAs)
  • Establish your design space
  • Develop a control plan as part of a risk management strategy
  • Ensure your process is in (statistical) control and capable

Course Outline

Chapter 1 – Introduction to Quality by Design (QbD)
1.1 Quality by Design (QbD) principles
1.2 Product Quality System framework

Chapter 2 – Primer on Statistical Analysis
2.1 Basic statistics
2.2 Confidence intervals and hypothesis testing
2.3 ANOVA and regression
2.4 Blocking

Chapter 3 – Foundational Requirements for QbD Studies
3.1 Setting specifications
3.2 Measurement Systems Analysis (MSA)
3.3 Quality Control Charts

Chapter 4 – Introduction to Design of Experiments (DOE)
4.1 Steps to DOE
4.2 Defining critical-to-quality attributes (CQAs)
4.3 Identifying and prioritizing potential process parameters

Chapter 5 – Screening Designs – Identifying Critical Process Parameters
5.1 Factorial designs
5.2 Fractional factorial designs
5.3 D-optimal designs

Chapter 6 – Response Surface Designs – Develop Functional Relationships and Establish Design Space
6.1 Classic response surface designs
6.2 I-optimal designs

Chapter 7 – Utilizing Systematic Understanding from QbD Studies
7.1 Presenting results
7.2 Developing a control plan as part of a risk management strategy
7.3 Statistical process control and capability

Chapter 8 – Advanced DOE Methodologies
8.1 Split-plot designs
8.2 Robust Parameter Design
8.3 Supersaturated Designs
8.4 Constrained Designs
8.5 Mixture Designs