Skip to content
2000
image of A Review on Advancement in Analytical Quality by Design (AQbD)

Abstract

Analytical Quality by Design (AQbD) represents a transformative methodology in pharmaceutical development, anchored in a systematic, risk-based, and data-driven framework. This approach optimizes analytical methods, fostering heightened product quality, efficient regulatory compliance, and informed decision-making. The industry's increasing acceptance of AQbD principles signifies a paradigm shift towards enhanced efficiency, sustainability, and global harmonization. This review comprehensively explores AQbD principles, regulatory perspectives, and its applications, particularly in analytical method development, including high-performance liquid chromatography (HPLC) and high-performance thin-layer chromatography (HPTLC). Emphasis is placed on the symbiotic relationship between AQbD and analytical method validation (AMV), elucidating their collective role in ensuring reliable and accurate analytical results. Integrating AQbD in method transfer, automation, and control strategies underscores its pivotal role in achieving robust, efficient, and compliant analytical processes. The review delves into lifecycle management and continuous improvement, coupled with AQbD principles, ensuring sustained method reliability throughout the pharmaceutical product lifecycle. AQbD's significant contribution to pharmaceutical lifecycle management, optimization, and change control is explored, emphasizing its systematic, data-driven, and risk-based approach to method development, validation, and ongoing enhancement. This review illuminates AQbD's transformative impact on pharmaceutical analysis, aligning with industry trends toward quality, efficiency, and regulatory compliance.

Loading

Article metrics loading...

/content/journals/cac/10.2174/0115734110321580240924073705
2024-10-07
2024-11-23
Loading full text...

Full text loading...

/content/journals/cac/10.2174/0115734110321580240924073705
Loading
/content/journals/cac/10.2174/0115734110321580240924073705
Loading

Data & Media loading...

This is a required field
Please enter a valid email address
Approval was a Success
Invalid data
An Error Occurred
Approval was partially successful, following selected items could not be processed due to error
Please enter a valid_number test