International Journal For Multidisciplinary Research

E-ISSN: 2582-2160   •   Impact Factor: 9.24

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Volume 8 Issue 5
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Quality Tools And Risk-Based Approaches In Analytical Method Validation And Bioequivalence Studies: A Comprehensive Review

Author(s) Ms. Karthika K.U., Ms. Shahanas Fathima V.V.
Country India
Abstract Analytical method validation and bioequivalence (BE) studies are important components of pharmaceuticaldevelopment because they provide evidence that analytical procedures are fit for their intended purpose and thatcomparative product performance can be assessed using reliable measurements. The contemporary regulatoryenvironment increasingly emphasizes scientific understanding, lifecycle management, quality risk management,and data integrity rather than validation as a one-time documentation exercise. This review examines practicalquality tools that can be integrated into analytical method development, validation, routine analysis,bioanalytical sample analysis, and BE study documentation. Particular attention is given to checklists, risk
matrices, Failure Mode and Effects Analysis (FMEA), Ishikawa or fishbone analysis, root-cause analysis (RCA),control charts, trend analysis, analytical run review, system suitability verification, and data-integrity checks.The review also considers how risk-based controls can be connected with validation characteristics such asspecificity/selectivity, accuracy, precision, linearity, range, robustness, and detection or quantitation capability.For BE studies, quality controls are discussed across study planning, sample accountability, bioanalyticalanalysis, pharmacokinetic data handling, statistical evaluation, and final reporting. ICH Q2(R2), Q14 and Q9provide an important quality framework, while ICH M10, ICH M13A and current FDA recommendations provideadditional context for bioanalytical and BE activities. An integrated quality-tool framework can improveconsistency, traceability, early detection of failure, and continual improvement without replacing scientificjudgment or applicable regulatory requirements.
Keywords Analytical method validation; Bioequivalence; Quality tools; Risk management; FMEA; ICH Q2(R2); ICH Q14; ICH Q9; ICH M10; Data integrity; System suitability; Pharmaceutical quality.
Field Medical / Pharmacy
Published In Volume 8, Issue 5, September-October 2026
Published On 2026-09-27
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CrossRef DOI prefix of IJFMR is 10.36948/ijfmr

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