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.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.
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).
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.
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.
This proposed procedure assumes that the instrument has been selected and the method has been developed.
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.
Initial parameters should be chosen according to the analyst’s experience and best judgment.
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.
The validation procedure in this particular article is based on requirements for EU multistate registration.
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.
Table 2 gives examples of which parameters might be tested for a particular analysis task.