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OUT OF SPECIFICATION SOP EXAMPLE-TEMPLATE

PURPOSE

This Example-Template standard operating procedure defines the policy and procedures for the investigation, documentation, and handling of known laboratory errors and discrepant (out-of-specification and atypical) laboratory test/data results performed by personnel in a typical pharmaceutical analytical R&D/QC laboratory.

SCOPE

The procedure is applicable to all:

     • Physical, chemical, biological and microbiological laboratory testing conducted for the following:  excipients,

       raw materials, active pharmaceutical ingredients (API), active biological ingredients, in-process materials,

       finished goods, container/closure components and labeling, process water, and utilities.
     • Bulk, formulated drug products an biologics, validation testing and stability testing.
     • Multi-stage tests with pre-defined acceptance criteria, such as Uniformity of Dosage, Dissolution, Limulus

       Amebocyte Lysate (LAL) and Conductivity that are found in Compendial and Regulatory Guidance

       documents.
     • Calibration and Equipment Qualification.

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
     • References
     • Attachments
     • Revision History

COST

The example-template is a 55 page SOP in MS Word® format available on CD for $49.95 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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