QUALITY BY DESIGN - Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing - page 86

QUALITY BY DESIGN

BRUCE S. DAVIS

5.1 BACKGROUND

The term quality by design or QbD is increasingly used in the pharmaceutical
industry and normally describes a science- and risk-based approach to developing
and manufacturing pharmaceutical products, based on the principles laid out in
the following International Conference on Harmonization (ICH) guidances:

• Q8R2: pharmaceutical development [1]
• Q9: risk management [2]
• Q10: pharmaceutical quality system (PQS) [3]
• Q11: development and manufacture of drug substances—chemical entities
and biotechnological/biological entities.

These ICH guidelines are voluntary but have set the scene for an alternative
way for the pharmaceutical industry to develop and manufacture its products.
Each guideline is discrete in its own right, but they should be read together to
understand the full impact of this new way of working.
A QbD or “an enhanced approach,” a term that ICH Q8R2 uses, is where
quality is designed in from the outset, using a science and risk basis, as opposed to
a traditional approach, where normally end-product testing used to check quality
requirements have been met.