Handbook of Analytical Validation

Ira S. Krull Contains practical, up-to-date guidelines for analytical method validation Includes a summary of the latest regulatory requirements for all aspects of method validation Includes coverage of areas such as quality control, cleaning validation, and R&D validation Leads the reader through the steps required by all major regulatory agencies when validating any analytical method, even those coming from the USP, but undergoing modifications.

Written for practitioners in both the drug and biotechnology industries, this handbook carefully compiles the current regulatory requirements to correctly and properly validate a new or modified analytical method. TheHandbook of Analytical Validationis designed to teach readers how to fully and correctly adapt new or modified analytical methods to meet regulatory requirements. The contents offer the latest regulatory requirements for submitting applications for new drugs or other applications, as regards analytical method validation. The chapters apply to both small molecules in the conventional pharmaceutical industry, as well as for biopolymers derived from the biopharmaceutical industry.

Table of Contents
Contents
Introduction
AIQ
Method Development and Optimization
Method Validation Terms and Definitions
System Suitability
Methods of Quantitation
Documentation
Statistics
Setting Specifications
Laboratory Inspection Trends
Special Topics
Out of Specification Results
Developing and Validating HPLC Stability indicating Methods
Validation Vs. Qualification Vs. Verification
Adopting New Technology in a Regulated Environment
HPLC Robustness Testing
Transferring Methods
Bioanalytical Method Validation
Validating Methods for Biotech Products
Validating HPLC Peptide Mapping
Developing and Validating Disso Methods
Cleaning Validation
Glossary of Terms
Abbreviations
Web Resources