Methods in validating tests
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Twelve 2-day In-person Interactive GMP and Validation Seminars available in America, Europe and Asia delivered by Dr. Understanding the Final FDA Guidance for Validation of Analytical Methods With 10 best practice guides for easy implementation Recorded, available at any time Analytical Instrument Qualification According the new Revision of USP Effective Validation of Analytical Methods for GLP and Clinical Studies Learn how to design, prepare, conduct and document for FDA Compliance Recorded, available at any time Impact of Quality by Design on the Analytical Laboratory Learn through examples on development and validation of analytical procedures Recorded, available at any time Quality by Design (Qb D) for Analytical Method Development and Validation Learn how to design robustness for easy transfer and to avoid OOS situations Recorded, available at any time Recorded, available at any time Eight Steps for Cost-effective Laboratory Compliance Up-to-date overview, hot topics and trends. Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use.
Green (11) gave a practical guide for analytical method validation, with a description of a set of minimum requirements for a method.Users must determine the suitability of Reference Standards for applications and uses not in the USP–NF, Food Chemicals Codex, or Dietary Supplements Compendium.Any other non-specified compendial use is at the User’s sole risk and expense.Renger and his colleagues (12) described the validation of a specific analytical procedure for the analysis of theophylline in a tablet using high-performance thin layer chromatography (HPTLC).
The validation procedure in this particular article is based on requirements for EU multistate registration.
Winslow and Meyer (16) recommend the definition and application of a master plan for validating analytical methods. Breaux and colleagues have published a study on analytical methods development and validation (17).