Pharmaceutical Quality by Design (QbD): Understanding its Principles

• By: Staff Editor
• Date: October 27, 2016
• Source: http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf

Pharmaceutical Quality by Design (QbD): Understanding its Principles

Quality is a prime factor of importance in this era of competition. More and more pharmaceutical companies today are embracing the principles of Quality by Design (QbD) for development and manufacturing. The principles of quality have been defined by three the ICH guidelines: Q8 on pharmaceutical development, Q9 on quality risk management and Q10 on pharmaceutical quality system.

QbD is a recent concept which has been included as an annex to ICH Q8 Guidance. QbD enables better process understanding, and a more scientific approach to development rather than mere testing of the final product.