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Technology Transfer SOP Example-Template

PURPOSE

This example-template standard operating procedure defines consistent and controlled practices for transferring validated analytical technology to a laboratory (where the method was not developed and validated) in order to qualify that laboratory to perform the analytical technology, consistently and accurately, and to document  that proof of proficiency has occurred.

 SCOPE

This SOP applies to the qualification of a laboratory to perform all (Compendial and non-Compendial) analytical technologies (chemical, physical, biological and microbiological test procedures) that need to be used when testing:

·      Commercial drug products (including validation batches) for release and stability and complaint samples.

·      Clinical drug products for release and stability.

·      Active pharmaceutical ingredients (API) for release and stability when intended to be used to manufacture

       commercial drug products and clinical drug products or used to generate stability data to support

       registration.

 

·      Isolated intermediates and in-process samples with specifications, used in the manufacture of commercial

       drug products, clinical drug products, and API used to manufacture commercial drug products or clinical

       drug products.

·      Process ranging batches in support of the development of commercial products.

·      Components (all raw materials and packaging (container/closure) materials) for release and stability when

        used to manufacture commercial drug products and clinical drug products or used to generate stability data

        to support registration.

·      Cleaning validation samples to support manufacture of clinical and commercial API and drug product

        batches.

·       Identification testing to support API site to site transfer for the manufacture of drug product.

·       Environmental samples to support the manufacture of clinical and commercial API and drug products.

This SOP applies to the transfer and qualification of test procedures from:

·       Building to building (on the same site) unless the laboratories are under the same management and the

         scientific rationale not to transfer is documented and approved by the management who has responsibility

         for all affected laboratories.

·       Site to site

CONTENTS

Each of the following sections, contain sufficient detail to allow the SOP to be implemented immediately, are included in the SOP:

     • Purpose
     • Scope
     • Responsibilities
     • Definitions
     • Procedure
     • Documentation
     • Process Diagram
     • Revision History

COST

The example-template is a 20 page SOP in MS Word® format available on CD for $19.95 plus $3.00 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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