A Survey on the Implementation of Analytical Quality by Design in Method Development in the Pharmaceutical Industries...

Analytical Quality by Design (AQbD) is a systematic approach that integrates quality into method design, ensuring robustness, fitness for purpose, and consistency throughout the lifecycle. This study aimed to assess the current scenario, benefits, and challenges of implementing AQbD in analytical method development within the pharmaceutical industry. The methodology included a questionnaire survey applied to pharmaceutical companies, complemented by insights from the literature to contextualize regulatory and scientific challenges. While AQbD offers a promising approach for developing robust methods, its full adoption faces technical, operational, and regulatory barriers. The survey found that although 88.3% of the responding companies are familiar with AQbD, only 50% have begun implementation, mainly in early stages with a focus on tools like design of experiments and risk assessment. Key AQbD components remain underutilized. The main barriers to implementation include a lack of technical resources, qualified personnel, cultural resistance, and unclear regulatory requirements. The literature indicates that AQbD has been widely applied. However, methodological inconsistencies persist. The comparative analysis revealed the alignment between literature and practice regarding benefits but also highlighted gaps in AQbD implementation. By identifying the specific challenges faced by regulated sectors, this study provides valuable insights for regulatory agencies to anticipate future needs, refine guidelines, and promote harmonized standards that ultimately strengthen analytical method quality and ensure consistent product quality throughout the lifecycle.