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CHROMATOGRAPHIC METHODS VALIDATION REPORT
EXAMPLE-TEMPLATE
PURPOSE
At the completion of methods validation experiments and protocol execution, the results are normally incorporated into validation report. Although each validation report will be unique, the format and contents of the report can be standardized. The example-template provided is standardized format which organizes and presents the data into an industry accepted format.
SCOPE
The example-template can be used to generate a methods validation reports following validation of a chromatographic methods. It is applicable to all USP method categories and can be modified as appropriate.
CONTENTS
The methods validation report example-template contains the following components:
1. Cover Page and Title
2. Table of Contents
3. Introduction
4. Purpose
5. Experimental
6. Results and Discussion
7. Conclusion
8. Figures
9. Analytical Method
10. Protocol
11. Protocol Deviations
Example figures, tables, plots, and calculations are also included.
COST
The example-template is an 85 page SOP in MS Word® format available on CD for $149.95 plus $5.00 for shipping and handling.
ORDERING INFORMATION
Example-template is available for purchase on Delphi Analytical Services, Inc.’s website www.delphianalytical.com . Go to product purchase and choose either e-mail or fax purchase, or contact:
Marketing and Communications Department
Delphi Analytical Services, Inc.
P.O. Box 487
Indian Rocks Beach, FL 33785
Phone 727-642-0192
Fax 727-593-3595
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