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.Final parameters should be agreed between the lab or analytical chemist performing the validation and the lab or individual applying the method and users of the data to be generated by the method.

Wegscheider (13) has published procedures for method validation with a special focus on calibration, recovery experiments, method comparison and investigation of ruggedness. (14) have described how analytical methods are validated in a Japanese QC laboratory.

The AOAC (15) has developed a Peer-Verified Methods validation program with detailed guidelines on exactly which parameters should be validated.

The scope of the method should also include the different types of equipment and the locations where the method will be run.

For example, if the method is to be run on a specific instrument in a specific laboratory, there is no need to use instruments from other vendors or to include other laboratories in the validation experiments.

Below is the list of evaluation instruments developed under DEVISE, and referred to in the User's Guide.

All instruments have been tested with adult audiences, unless otherwise specified. Each instrument comes with instructions for use and scoring.

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.

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).