QbD- QUALITY BY DESIGN ANALYTICAL METHOD DEVELOPMENT AND VALIDATION-AN OVERVIEW

QbD- QUALITY BY DESIGN ANALYTICAL METHOD DEVELOPMENT AND VALIDATION-AN OVERVIEW S. Harshini T. Sudha

The idea of "Quality by Design" (QbD) has attracted much focus among the prescription drugs sectors for sustaining Quality. It acts as a link between the pharmaceutical sector and drug regulating agencies, supporting the shift to a proactive, scientific, risk-based, and integrated method for approaching pharmaceutical product creation. It mostly entails creating formulas and manufacturing procedures to ensure product quality. The design, development, and production of high-quality pharmaceutical goods are areas where QbD can add value. FDA, the Food and Drug Administration & the International Conference of Harmonization (ICH) are heavily promoting quality by design (QbD) to reduce the rising costs of development and regulatory barriers to creativity and innovation. The ICH guidelines, the three components that make up QbD's foundation are, (quality risk management) Q9, Q10 (quality systems), and (pharmaceutical development) Q8. As part of the (QbD) approach, the formulation and process are designed and developed using the quality target product profile (QTPP), key quality attributes (CQA), risk assessment, and life cycle management. This review focuses on the basic concept of (QbD) its applications, ICH guidelines, the process of the development of an analytical method using the QbD approach, various RP-HPLC method creation and verification by using the QbD approach, different analytical techniques using QbD and method validation regulation.
2024 2024 1309 1314 10.31788/RJC.2024.1738778 https://rasayanjournal.co.in/admin/php/upload/4306_pdf.pdf https://rasayanjournal.co.in/admin/php/upload/4306_pdf.pdf