Validation in Thermal Analysis

Beschreibung

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
Validation of both equipment and method is an essential for modern analytical methods Contains all aspects of validation of computerized systems, including regulatory requirements, the validation process, qulification steps, and auditing vendors Covers all aspects of method development and validation, to ensure the quality and reliability of results Many practical examples, especially concerning the thermal analysis of materials such as plastics and rubber

Autor*in

Markus Schubnell
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.

Themen in »Validation in Thermal Analysis«

21 CFR 11 Analytical methods Analytical procedures EU GMP Annex 11 Instrument qualification Interlaboratory studies Measurement errors Thermal analysis Thermogravimetry Validation

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