Quality by Design for the Life Cycle of an Analytical Procedure (2.0 days)

Quality by Design for the Life Cycle of an Analytical Procedure (2.0 days): The pharmaceutical industry relies on analytical procedures for the combined practices of process and formulation development, process validation, and manufacturing, as well as both in-process and final-product testing. These test methods need not only be validated but reliable and fit for its intended use. This course provides a systematic approach to the lifecycle of analytical procedures that begins in procedure design and development, continues in procedure performance qualification, and is maintained in continued procedure performance verification.

Quality by Design for the Life Cycle of an Analytical Procedure

• Apply a Quality by Design (QbD) approach throughout the lifecycle of an analytical procedure.
• Reference legal and regulatory documents reference requirements for analytical validation.
• Describe the principles of analytical validation referenced by those documents.
• Set analytical procedure validation requirements that are fit for their intended use.
• Apply the statistical tools for QbD throughout the lifecycle of an analytical procedure.

Outline:

1. Introduction to AQbD
   • AQbD principles
2. Primer on Statistical Analysis
   • Basic Statistics
   • Statistical intervals and hypothesis testing
   • ANOVA and regression
   • Process control charts and capability
3. USP <1225> and ICH Q2
4. Stage 1: Procedure Design
   • Defining fitness for intended use
   • Design considerations
5. Stage 2: Procedure Performance Qualification (PPQ)
   • Analysis – FUV CD
   • Analysis – AUC
6. Stage 3: Continued Verification
   • System suitability and analytical control.
   • Continued verification.