Pharma Bio World brings you an issue themed on Quality by Design (QbD). QbD is applied to build quality in a product based on scientific knowledge and understanding of its characteristics plus its process of manufacturing. ‘FDA’s Pharmaceutical cGMPs for the 21st Century: A Risk Based Approach’ first familiarised the idea of QbD in the pharmaceutical regulatory environment.
Although the regulatory standards in the pharmaceutical industry have been in a process of continuous evolution, the primary emphasis of these developments has always remained constant- ensuring product quality/ efficacy and process robustness with the sole intention of safeguarding patient safety.
