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).Representatives of the pharmaceutical and chemical industry have published papers on the validation of analytical methods.Recorded, available at any time Verification of Compendial Methods according to the New USP Chapter Understand the new risk based approach and and get real world case studies for testing Recorded, available at any time Effective HPLC Method Development and Validation Preparation, conduct and documentation for FDA/EMA Compliance Recorded, available at any time Recorded, available at any time Development and Validation of Stability Indicating Methods for FDA/ICH Compliance Sample generation - method development - validation - documentation Recorded, available at any time Bioanalytical Method Validation Conduct and Document for Efficiency and FDA and EMEA compliance Recorded, available at any time Residual Solvent Analysis According to USP Recorded, available at any time System Suitability Testing in Compendial Chromatographic Methods Understanding and Implementing Recent Changes of USP and EP Recorded, available at any time With compliance master plan, checklists, examples, audio seminar and 31 SOPs for easy implementation Click here for more info The Laboratory compliance package includes 31 SOPs. The package includes 50 FDA and international regulations and guidelines Here Ludwig Huber (right) in the Q&A Discussion Session on Laboratory Compliance at a ISPE/FDA Beijing University Conference with Nick Buhay, Acting Director in FDA/CDER's Division of Manufacturing and Product Quality A large portion of this tutorial comes from the book: Validation and qualification in Analytical Laboratories, published by Informa in 2007. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice.Analytical methods need to be validated or revalidated The FDA has also published a guidance for the validation of bioanalytical methods (8). The report presents guiding principles for validating studies of both human and animal subjects.
Initial parameters should be chosen according to the analyst’s experience and best judgment.It meets criteria such as ease of use; ability to be automated and to be controlled by computer systems; costs per analysis; sample throughput; turnaround time; and environmental, health and safety requirements.Successful acceptance of the validation parameters and performance criteria, by all parties involved, requires the cooperative efforts of several departments, including analytical development, QC, regulatory affairs and the individuals requiring the analytical data.In this way, the experiments can be limited to what is really necessary. Validation parameters for specific tasks The validation experiments should be carried out by an experienced analyst to avoid errors due to inexperience.The analyst should be very well versed in the technique and operation of the instrument.
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).