Method Development & Validation
Fit-for-purpose analytical methods supported by an appropriate lifecycle strategy.
Method Development and Validation Support
Analytical methods should be fit for their intended purpose and supported by an appropriate lifecycle strategy. Globyz Clinical Solutions evaluates the analytical objective, product matrix, specification, regulatory context, equipment, standards, sensitivity, and risk before proposing method development or validation work.
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Lifecycle Strategy
Fit-for-purpose analytical methods
Method
Development
Development work may include review of existing information, selection of analytical conditions, sample preparation, separation or detection optimization, system suitability, robustness considerations, and preliminary specificity or stability indicating assessment, subject to available capability.
Validation Planning
Each validation program begins with a protocol that clearly defines the method’s intended use, scope, performance characteristics, analytical ranges, acceptance criteria, sample and standard strategy, calculations, deviation management, review and reporting requirements.
The resulting evidence demonstrates that the analytical method is scientifically sound, reproducible, reliable and suitable for its intended use and regulatory purpose.
Validation Evaluates:
Lifecycle Support
Changes, transfers, atypical performance, specification revisions, new product strengths, equipment changes, or new intended uses may require supplemental evaluation.
Partial Validation
Targeted validation studies designed to address specific changes in method parameters or scope.
Revalidation
Comprehensive re-evaluation of analytical performance to ensure continued suitability.
Documented Justification
Scientific rationales for method changes supported by data and risk assessment.
Technical Review
"The final scope depends on method purpose, instrument configuration, standards, samples, personnel, schedule, and quality approval. No development or validation claim is made until feasibility and scope are confirmed."
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