Paper Title
Advancing Analytical Method Validation: Lifecycle and Risk-Based Approaches under ICH Q2(R2)
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Registration ID: IJNRD_310450
Published ID: IJNRD2511158
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Keywords
ICH guidelines, LOD, LOQ, Analytical Quality by Design (AQbD), Regulatory Standards
Abstract
The "international council on harmonisation of technical requirements for registration of pharmaceutical for human use" (ICH) is an initiative that brings together the pharmaceutical industry and regulatory bodies to discuss scientific and technical aspects of the development and registration of pharmaceutical products. The "Q" series quality criteria for harmonisation are part of the ICH guidelines. In order to create a new quality guideline and provide principles pertaining to analytical development procedures, an amendment to the creation of analytical procedures and modifications to the validation of analytical procedures ICH Q2 (R1) are recommended. This review offers a thorough comparison of the revised Q2(R2) guideline and ICH Q2(R1), emphasising significant modifications to validation parameters such specificity, linearity, accuracy, precision, limit of detection (LOD), and quantitation (LOQ). The expanded use of risk assessment tools, system suitability, improved method performance criteria, and the incorporation of Analytical Quality by Design (AQbD) principles are among the recently added components that are also examined in this review. The actual effects of applying Q2(R2) in pharmaceutical laboratories, such as method lifecycle ideas and method performance verification, are also covered in this study. The study seeks to support professionals in implementing a methodical, risk-based approach for method validation that is in line with international regulatory standards through case studies and regulatory insights.
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How To Cite (APA)
Jeevan Ravikumar Deshmukh, Snehal Dhanaji Mane, Vaishnavi Mahadeo Bhadalkar, Anjali Dnyaneshwar Gaddapwar, & Vaishnavi krushna solanke (November-2025). Advancing Analytical Method Validation: Lifecycle and Risk-Based Approaches under ICH Q2(R2). INTERNATIONAL JOURNAL OF NOVEL RESEARCH AND DEVELOPMENT, 10(11), b514-b520. https://ijnrd.org/papers/IJNRD2511158.pdf
Issue
Volume 10 Issue 11, November-2025
Pages : b514-b520
Other Publication Details
Paper Reg. ID: IJNRD_310450
Published Paper Id: IJNRD2511158
Research Area: Pharmacy All
Author Type: Indian Author
Country: Nanded , Maharashtra , India
Published Paper PDF: https://ijnrd.org/papers/IJNRD2511158.pdf
Published Paper URL: https://ijnrd.org/viewpaperforall?paper=IJNRD2511158
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