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CHROMATOGRAPHIC METHODS VALIDATION SOP

EXAMPLE-TEMPLATE

PURPOSE

This example-template procedure is intended to provide general guidelines for the validation of chromatographic methods for the analysis of drug substance and drug product. This procedure is primarily written for the pharmaceutical industry, but is also applicable to other fields in that it is base on sound scientific principals and broadly recognized practices. This procedure is primarily intended for validation of High Performance Liquid Chromatographic (HPLC) methods but is applicable, with modification, to other chromatographic techniques. The example-template is a comprehensive document which may be used “as is” or modified to meet the requirements of the particular organization.

SCOPE

This example-template is applicable to any analytical laboratory which is involved in the research, development and validation of chromatographic methods which will be used to ensure the identity and measure the strength, quality, purity, and potency of active pharmaceutical ingredients and drug products. This procedure is in alignment with current industry practice and current ICH and FDA guidelines.

CONTENTS

This example-template SOP contains the following components:
 

1. Purpose
2. Scope
3. Responsibilities
4. Definitions
5. Procedures
6. References
7. Attachments including:

     a. Attachment I: Glossary of Terms
     b. Attachment II: USP Method Categories and Analytical Performance Characteristics Evaluation   and Testing Required for Validation
     c. Attachment III: Recommended Experimental Procedures and Acceptance Criteria: Category I

          (Assay) Methods
     d. Attachment IV: Recommended Experimental Procedures and Acceptance Criteria: Category II

        (Impurity and Degradants) Methods
     e. Attachment V: Recommended Experimental Procedures and Acceptance Criteria: Category III

          (Dissolution) Methods
     f. Attachment V: Recommended Experimental Procedures and Acceptance Criteria: Category IV

        (Identification) Methods

COST

The example-template is a 150 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 . Look under 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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