About QbD/DOE QbD is a concept called ‘Quality by Design’, which aims to build quality into processes by design. This implies

  • Quality cannot be improved by testing alone
  • QbQ enables building robustness in the process
  • QbD explains the steps to arrive at the finished process parameters
  • QbD requires to demonstrate the robustness of the process
  • QbD approach results in design space, which is a wider range of process parameters
  • Manufacturing with in the approved design space provides opportunities to yield products without filing post-approval change

Necessity for QbD

  • Pharmaceutical manufacturers have to get it “ right at first time” and continue to improve
  • Pharmaceutical industries are unable to have innovative technologies as and when they want because of regulatory constraints resulting in economic difficulties, unlike other chemical and petro chemical industries.
  • QbD approaches to drug development could increase efficiencies, provide regulatory relief and flexibility, and offer important business benefits throughout the product’s life cycle.
  • QbD has been framed by the ICH (International Conference on Harmonization), whose members are the countries of Japan, USA and Europe. Adoption of QbD will result in easier access to international markets.
  • QbD has become mandatory by regulators for generic products.

QbD Tools

  • ICH Q8 (DOE, Design of Experiments) to establish the CPPs (critical process parameters) to obtain CQAs (Critical Quality attributes) and Design Space as envisaged.
  • ICH Q9 (QRM, Quality Risk management).
  • ICH Q10 (Knowledge Management)
  • ICH Q11 (For API)

Design of Experiments (DOE)

DOE is a systematic, planned approach to solving problems by gaining information through carefully planned statistically designed
experiments. These experimental studies have adequate statistical properties to be able to

  • Accurately measure the effects of process factors on the key response variable(s) (e.g. purity, impurity profile ,dissolution, content uniformity, etc.)
  • determine if these factor effects are real (above the noise level) and if so to accurately quantify these effects

Businesses are run around corner stones of quality, costs and delivery. The experimental work planned by DOE will enable scientists
to build quality in the process and products, reduce costs and delivery time.
AQbD (Analytical Quality by Design)
Food and Drug Administration (FDA) has approved a few new drug applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical approach. The concept of QbD applied to analytical method development is known now as AQbD (analytical quality by design).