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This inevitably requires methods which generate high-quality results.Method development is a core capability at Averica.The key point is to develop methods for easy validation and revalidation. Krause published a guide for analytical method transfer, comparability, maintenance and acceptance criteria for the testing of biopharmaceuticals (18).This primer gives a review and a strategy for the validation of analytical methods for both methods developed in-house as well as standard methods, and a recommendation on the documentation that should be produced during, and on completion of, method validation.The preparation and execution should follow a validation protocol, preferably written in a step-by-step instruction format.
The most comprehensive document is the conference report of the 1990 Washington conference: Analytical Methods Validation: Bioavailability, Bioequivalence and Pharmacokinetic Studies, which was sponsored by, among others, the American Association of Pharmaceutical Scientists (AAPS), the AOAC and the U. The report has also been used as a basis for the FDA industry guidance document (8).
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.
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Green (11) gave a practical guide for analytical method validation, with a description of a set of minimum requirements for a method.
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 AOAC (15) has developed a Peer-Verified Methods validation program with detailed guidelines on exactly which parameters should be validated.