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VALIDATING CHROMATOGRAPHIC METHODS:

A PRACTICAL GUIDE

DESCRIPTION

FDA in its most recent Guidance for Industry on Analytical Procedures and Methods Validation states “Methods validation is the process of demonstrating that analytical procedures are suitable for their intended use. The methods validation process for analytical procedures begins with the planned and systematic collection by the applicant of the validation data to support analytical procedures”.

What FDA does not say is that the actual validation component of the methods validation process should be the culmination of a well organized, well planned and systematically executed process which includes methods development, pre-validation studies, and finally methods validation itself. Gone are the days where one did methods development/validation concurrently. Validation is the end game, where few surprises and deviations are expected. Validation is executed with a formal, approved and signed methods validation protocol in place which has been reviewed by the Quality Assurance Unit. Validation is complete when you have (1) Demonstrated that you have met all the acceptance criteria. (2) Have clearly documented the results in a CGMP compliant fashion, and (3) Have shown how you met the acceptance criteria in a final methods validation report, including references to raw data, all of which has been reviewed and approved by the appropriate personnel including peers, management and QA. Some would even argue that the validation process is not complete until the methods are successfully transferred to their end user laboratories.

This can be a daunting task. There is nothing trivial or easy about methods validation. It takes time, resources, and rarely goes as easy as you think it’s going to go. Methods validation is part science, part art, and a lot of bookkeeping and accounting. And unfortunately, not many laboratories do a very good job in executing all of the components.

“Validating Chromatographic Methods” is a detailed roadmap show all of the steps required to validate a chromatographic method. In addition it provides all the tools and templates, on CD-ROM, needed to assist you to properly and efficiently validate you chromatographic methods. It is based on current industry standards and regulatory guidance documents. Templates and examples are taken from real world examples.

INTENDED AUDIENCE AND USE

“Validating Chromatographic Methods” was specifically created for analytical research and development laboratories or technical services laboratories who are actively involved in developing and validating HPLC methods for use in pharmaceutical QC laboratories. It is also directly applicable to validation of USP and EP methods.

CONTENTS

Each of the required steps, in addition to other details, for validating a chromatographic method is clearly detailed and documented in a series of flow diagrams and checklists. All procedures are compiled into a concise and user friendly manual, which also contains numerous templates, tools, and instruments provided on CD-ROM for modification and use. Sections of the manual include:

1.      Overview of Methods Validation                                                                                 

2.      Components of Methods Validation                                                                         

3.      Step 1: Method Evaluation and Further Method Development                                   

4.      Step 2: Final Method Development and Trial Method Validation                         

5.      Step 3: Formal Method Validation and Report Generation                                      

6.      Step 4: Formal Data Review and Report Issuance                                           

7.      Summary     

8.      Appendixes:

            I.      GLOSSARY OF METHODS VALIDATION TERMS

            II.     METHODS VALIDATION SOP EXAMPLE-TEMPLATE  

            III.    END USER REQUIREMENTS QUESTIONNAIRE EXAMPLE-TEMPLATE 

            IV.    METHOD REVIEW CHECKLIST  EXAMPLE-TEMPLATE

            V.      STANDARD TEST METHOD EXAMPLE-TEMPLATE

            VI.     METHODS VALIDATION PROTOCOL EXAMPLE-TEMPLATE  

            VII.    METHODS VALIDATION REPORT EXAMPLE-TEMPLATE

            VIII.   REFERENCES 

                    COST

The manual is available for $89.95 plus $5.00 for shipping and handling.

ORDERING INFORMATION

The Guide 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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