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A POCKET GUIDE TO CHROMATOGRAPHIC

METHODS VALIDATION

Delphi Analytical Services, Inc. has spent years helping companies in the Pharmaceutical Industry improve their level of compliance with Current Good Manufacturing Practices (CGMPs). This involvement has included large and small companies who have already been subject to regulatory action from FDA as well as companies who are taking preventative measures to avoid regulatory action. As part of this effort, a significant amount of time has been spent reviewing the chromatographic data and chromatographic methods validation reports.
This “pocket guide” is designed to provide an overview of chromatographic methods validation.

INTENDED AUDIENCE AND USE

This Guide is intended to be used as a quick reference or “sanity check” to insure that you are addressing the major issues associated with validating chromatographic methods. An in depth description of chromatographic methods validation can be found in our book “A Practical Guide to Validating Chromatographic Methods”.

This guide is an excellent means for you to review and evaluate your existing methods validation SOPs and practices. It also gives some good suggestions on the experiments you need to conduct during methods validation.

This guide may also be used as a primer or introduction to methods validation in CGMP environments for new employees or for employees who are cross-training from other areas within the organization.

CONTENTS

1.   Introduction: Overview of Chromatographic Methods Validation
2.   Section 1: Accuracy (Recovery)
3.   Section 2: Precision
4.   Section 3: Specificity
5.   Section 4: Detection Limit
6.   Section 5: Quantitation Limit
7.   Section 6: Linearity
8.   Section 7: Range
9.   Section 8: Robustness Testing
10. Section 9: System Suitability Determination
11. Section 10: Forced Degradation Studies
12. Section 11: Solution Stability Studies
13. Section 12: Filter Retention Studies
14. Section 13: Extraction Efficiency Studies
15. Section 14: Method Categories and Required Analytical Performance Characteristic or Validation Test
16. Section 15: Reporting the Results
17. Section 16: Glossary of Common Methods Validation Terms
18. Section 17: Selected References
19. Section 18: Selected Vendors

COST

“A Pocket Guide to Chromatographic Methods Validation” is a 64 page booklet available for $9.95 plus $3.00 for shipping and handling. Volume orders and discounts are available.


ORDERING INFORMATION

“A Pocket Guide to Chromatographic Methods Validation” 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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