Glossary

ICH Q8

What is ICH Q8?

ICH Q8 (R2) is a regulatory guideline focused on pharmaceutical development, emphasizing a “Quality by Design” (QbD) approach. It provides a framework for developing and optimizing drug formulations and manufacturing processes to ensure consistent product quality.

What are the key components of ICH Q8?

Key components of ICH Q8 include:

  • Quality Target Product Profile (QTPP): Defines the desired attributes of the drug product.
  • Critical Quality Attributes (CQA): Identifies essential characteristics that impact product quality.
  • Design Space: Establishes a range of acceptable process parameters that ensure product quality.
  • Risk Management: Encourages the use of scientific knowledge and risk-based approaches throughout the development process.