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ICSOP0043.02

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United States Department of Agriculture

Center for Veterinary Biologics

Standard Operating Policy/Procedure

LSRTIS Special Test Request Procedures for Inspection and Compliance

Date: July 10, 2017

Number: ICSOP0043.02

Supersedes: ICSOP0043.01, November 8, 2013

Contact: Jeanette M. Watson, (515) 337-6119

Becky R. Rasmussen, (515) 337-6138

Approvals:

/s/Steven A. Karli Date: 10Aug17

Steven A. Karli, Director

Inspection and Compliance

Center for Veterinary Biologics

United States Department of Agriculture

Animal and Plant Health Inspection Service

P. O. Box 844

Ames, IA 50010

INTERNAL USE ONLY

Mention of trademark or proprietary product does not constitute a guarantee or warranty of the product by USDA 

and does not imply its approval to the exclusion of other products that may be suitable.

Entered into CVB Quality Management System

by: /s/Linda S. Snavely 10Aug17 

 Linda S. Snavely Date

 Quality Management Program Assistant
Center for Veterinary Biologics ICSOP0043.02

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LSRTIS Special Test Request Procedures for Inspection and Compliance

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Table of Contents

1. Purpose and Scope

2. Definitions/Acronyms

3. CVB-IC Test Request Policy

4. Submitting a Special Test Request

5. Laboratory Response to the Request

6. Review of the Special Request and Biologics Test Results

7. LSRTIS STR View

8. References

9. Summary of Revisions

 
Center for Veterinary Biologics ICSOP0043.02

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LSRTIS Special Test Request Procedures for Inspection and Compliance

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1. Purpose and Scope

The Center for Veterinary Biologics-Inspection and Compliance (CVB-IC) may request special 

testing on samples submitted by the manufacturer or on samples collected during an inspection 

or investigation as part of the regulations listed in title 9, Code of Federal Regulations (9 CFR),

part 113.6. This document covers the procedure to be used when requesting testing in response to 

firm requests, such as reprocessing, rebottling or extension of dating; in response to a suspected 

non-compliance or action item identified on an inspection report; or during an investigation.

This document also describes the CVB-IC testing policy and guidelines for entering special test 

requests (STR or SR) into the Licensing, Serial Release, and Testing Information System 

(LSRTIS) and the processing of these requests. 

Additional information regarding Special Request Testing associated with investigations is 

covered in the current version of CVBSOP0101, Tests Requested to Assist Investigations –

Processes and Responsibilities.

2. Definitions/Acronyms

2.1 Licensing, Serial Release, and Testing Information System (LSRTIS): This 

system is the laboratory information management system used by the CVB. 

2.2 Laboratory: The CVB Laboratory Sections (may be one or more Sections)

2.3 Special Request: A request for testing to be conducted at the Laboratory, 

sometimes referred to as a special test request, STR or SR.

2.4 Originator: The CVB-IC Biologics Specialist, Product Specialist, Senior 

Biologics Specialist, Section Leader, or Director requesting the test.

2.5 CBI: Confidential Business Information

2.6 PC: Program Coordinator

2.7 Verified: The process when complete test results are validated by a Laboratory 

Section Leader or designee. 

3. CVB-IC Test Request Policy

3.1 While it is CVB policy to select and initiate testing on product samples within 7

calendar days of receipt and on diagnostic test kits within 3 calendar days of receipt