Validation in Thermal Analysis

Dr. Markus Schubnell is a Thermal Analysis Application Specialist at Mettler-Toledo International, Inc., Switzerland. He coordinated the writing of this book with support from several colleagues in the Materials Characterization Support Group at Mettler-Toledo, and from industry and academic experts elsewhere.



The validation of equipment, processes and methods is a basic requirement that nowadays has to be met in most industries. This handbook deals with the validation of computerized systems in general as well as with analytical method validation. The many detailed practical examples focus on thermal analysis of materials, such as plastics and rubber.



The handbook is intended for newcomers interested in the theoretical and regulatory aspects of validation and for thermal analysis practitioners who have to validate their equipment and methods.



Contents:



Part 1: Validation of Computerized Systems

Recent Changes in Regulations and Regulatory Guidance

Instrument Qualification, Computerized System Validation and Method Validation

Regulatory Requirements for Computerized System Validation

Computerized System Validation

Writing the User Requirements Specification (URS)

Auditing the System Supplier

Installation Qualification and Operational Qualification (IQ and OQ)

Performance Qualification (PQ) or End User Testing



Part 2: Method Validation

Measurement Errors and Uncertainty of Measurement

Validation of Analytical Procedures and Methods

Interlaboratory Studies in Thermal Analysis

Method Development Through to SOP

Practical Examples



Appendix 1: 21 CFR Part 11 and EU GMP Annex 11

Appendix 2: Basic Statistics

Appendix 3: Standard Test Methods for Thermal Analysis