Method Validation in Pharmaceutical Analysis: A Guide to Best Practice, 3rd Edition (EPUB)

The most recent version of the industry standard for pharmaceutical analysis has been thoroughly revised to incorporate the new ICH Guidelines Q2(R2) and Q14.

Method Validation in Pharmaceutical Analysis offers practical information for readers engaged in the creation, validation, ongoing maintenance, and assessment of analytical procedures in pharmaceutical analysis, all while adhering to a comprehensive lifecycle approach to analytical processes.

Recent publications of the USP on Analytical Procedure Lifecycle Management, the work of the British Pharmacopeia AQbD Working Party, and the much-needed interpretation of the most recent ICH guidelines for validation and method development are all included in this recently updated and revised Third Edition. Additionally, it covers current issues in the industry such data integrity and ongoing analytical performance monitoring.

Method Validation in Pharmaceutical Analysis, authored by a group of very skilled pharmaceutical experts, contains details on pertinent subjects like:

Data governance, data integrity, data quality, system validation lifecycle, analytical instrument certification, and ongoing HPLC performance qualification
Analytical target profile, decision-making guidelines, suitability for the intended purpose, and analytical technique performance attributes
Risk assessment, analytical control plan, multivariate analytical techniques, and method creation, optimization, and selection
Compendial/pharmacopeia test procedure implementation, analytical procedure transfer, and a lifecycle approach to analytical procedure transfer

With its extensive coverage, Method Validation in Pharmaceutical Analysis is a vital resource for analytical chemists, QC and QA personnel, public authorities entrusted with pertinent regulatory duties, and scientists, researchers, and professionals in the pharmaceutical sector.