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ICSOP0018.04

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United States Department of Agriculture

Center for Veterinary Biologics

Standard Operating Policy/Procedure

Processing Facility Documents

Date: October 6, 2017

Number: ICSOP0018.04

Supersedes: ICSOP0018.03, June 17, 2013

Contact: William L. Huls, (515) 337-6193

Approvals:

/s/Steven A. Karli Date: 12Oct17

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 12Oct17

 Linda S. Snavely Date

 Quality Management Program Assistant
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Table of Contents

1. Purpose 

2. Definitions

3. Responsibilities

4. Procedures: Processing Plot Plans, Blueprints, and Legends

5. Summary of Revisions
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1. Purpose 

Facility documents are one of the foundational documents required when applying for and 

maintaining a U. S. Veterinary Biologics Establishment License or U.S. Veterinary Biological 

Permit for Distribution and Sale. This document clarifies the steps in processing incoming 

facilities document submissions, and reviewing these documents using title 9, Code of Federal 

Regulations (9 CFR), part 108, and Veterinary Services Memorandum 800.78 as guidance. 

2. Definitions

2.1 Plot Plan

A drawing that shows all of the buildings on a particular land area, even if the building is 

not used in the preparation of biologics.

2.2 Plot Plan Legend

Lists all buildings shown on the plot plan and gives a brief description of the building 

materials used for, and the functions performed in each building.

2.3 Blueprint

A drawing illustrating, in detail, buildings used for preparation of biologics.

2.4 Blueprint Legend

A listing of rooms on the blueprint; should include room identification, functions 

performed in room, decontamination/room management for the room and fractions in the 

room. A listing of stationary and other essential equipment for each room should also be 

included. 

2.5 Addendum

A listing attached to either the Plot Plan Legend or Blueprint Legend for a specific issue; 

such as an exemption to 9 CFR 109 or movement of products between two premises on 

the same establishment license. Addendums may also be used if the same information is 

repeated across several rooms.

2.6 Licensing, Serial Release and Testing Information System (LSRTIS) – Mail 

Log Module

This database system is the information management system used by the Center for 

Veterinary Biologics (CVB) to track incoming and outgoing submissions.
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3. Responsibilities

3.1 Document Export Examiner (Biologics Compliance Assistant position to 

provide backup)

Processes incoming facility documents, enters data, stamps filed facility documents, and 

mails copies to the establishments.

3.2 Biologics Compliance Assistant (BCA) – including Lead BCA

Performs preliminary review of facility documents to ensure the submission is complete. 

Finalizes outgoing documentation related to the facility documents.

3.3 Specialist

Performs secondary review of facility documents to ensure submission meets regulatory 

requirements, usually for establishments assigned to them. Drafts outgoing 

documentation.

3.4 Facilities Manager

Provides guidance regarding issues for the review of facility document review. Acts as a 

liaison with Policy, Evaluation, and Licensing (PEL) regarding facility documents. Drafts 

needed policy and ensures processes are documented.

3.5 Section Leaders

Provides guidance for overarching issues regarding facility document policy

3.6 Records Management

Ensures facility documents are filed in accordance with the current policy.

4. Procedures: Processing Plot Plans, Blueprints, and Legends

4.1 Overview

Prior to permitting or licensure of an establishment, the applicant must prepare and 

submit facility documents. These documents are reviewed prior to licensure and used 

during the prelicensing inspection. 

Revisions to facility documents are required for, but are not necessarily limited to the 

following:

1. Adding of an address (buildings) to an existing establishment license
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2. Adding of an address (buildings) for permitted product – as listed in the Outline 

of Production

3. Adding of a building to an existing address listed on the establishment license

4. Remodeling of an area or building used in the preparation of product

5. Removing a building from the licensed premises

6. Adding/changing functions, fractions, or room management in existing rooms 

used in the preparation of product (without remodeling)

Remodeling of an existing production building or addition of a new production building 

most likely will require an on-site inspection prior to filing of the documents or issuance 

of an updated establishment license.

4.2 Receipt of Incoming Facility Documents - See ICWI0910, Mail Receipt, 

Process, and Distribution for CVB-IC Hard Copy Submission, and ICWI0071, BCA 

Entry and Review of Incoming Correspondence

4.2.1 Facility document submissions are received hardcopy. 

4.2.2 The majority of prelicensing facility documents are submitted to PEL as 

part of the initial licensing package. They are logged out of the PEL Mail Log 

(ML) and logged into the Inspection and Compliance ML with an informational 

link to the original submission.

4.2.3 Preliminary drawings for new construction or remodeling may be 

submitted for comment prior to construction. These can be submitted via the 

NCAH Portal. The Submission Type should be General Correspondence (IC) and 

Submission Subtype should be Preliminary facility drawing. 

4.3 Preliminary Review – See ICWI0081, Preliminary Review of Facility 

Documents (BCA), and ICFRM0018, Facility Document Form Plot Plan/Plot Plan 

Legend – Preliminary Review (BCA), and ICFRM0019, Facility Document Form 

Blueprint/Blueprint Legend – Preliminary Review (BCA)

The function of the BCA review serves as a quality check on data entry and technical 

review of the documents for accuracy and complete submissions. 

4.3.1 If data entry errors are noted, the BCA corrects them during the review. 

4.2.2 If the facility document submission is incomplete, the BCA may return the 

submission to the establishment without further review. 

4.2.3 BCA may not return a Prelicensing Facility Document Submission. 

Deficiencies will be documented and the submission will be sent forward to the 

responsible Specialist. 
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4.2.4 Provides completed ICFRM0018 and/or ICFRM0019 to the Specialist 

with the facility documents for their review.

4.4 Specialist Review (see ICWI0083, Facility Documents: Specialist Review and 

Outgoing Correspondence)

4.4.1 The Specialist reviews facility documents for acceptability of the facility, 

processes, and equipment as related to the functions performed in the preparation 

of product. This includes review of the equipment listed, functions performed, 

fractions, decontamination procedures, methods to mitigate cross-contamination, 

biosecurity and biosafety practices related to all activities in the licensed 

premises. 

4.4.2 The Specialist provides outgoing correspondence. 

4.4.2.1 Fill out Facility Document Submission Form, sign and date.

4.4.2.2 If needed, attach completed ICTEM0045, Facility Document 

Correspondence.

4.5 Facility Document Finalization, see ICWI0072

A copy of the filed facility document(s) are maintained by CVB for reference. A copy is 

returned to the licensee/permittee.

4.6 Filing – See PIMSWI1004, IC Miscellaneous Filing - General Correspondence, 

Inspection Reports, Blue Print Correspondence, Certificates of Licensing and Inspection, 

Import/Export, and Product Information

5. Summary of Revisions

Version .04

 Complete revision of document based on business process improvement.

Version .03

 Changed “agenda” to addenda.

 2.2.1 Changed IC OAA to IC BOA or designee.

 2.2.1 First bullet added, All plot plans, blueprints, legends and associated addenda.
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 2.2.1 Added a new bullet point, “Logs the facility documents into the LSRTIS Mail 

Log (see ICWI0236, Work Flow for Correspondence for Inspection and Compliance: 

Using the Mail Log System)”. 

 2.2.1 Added (see Section 6 of ICWI0910.02, Mail Receipt, Process and Distribution) to 

third bullet point.

 2.2.2 Added a new bullet stating, “Self assigns mail log item”.

 2.2.2 Added statement, “Moves mail log item to Specialist Review”.

 2.2.3 Removed “The submission is not split into separate accepted or rejected parts”

under the fourth bullet point.

 2.2.3 Removed “...a hard copy of the draft cover letter,...” Added “Using the mail log 

system an.....” under the sixth bullet point.

 2.2.4. Added “...and/or rejected..,” under first bullet point.

 2.2.4 Added to second bullet, “A third copy may be approved and stamped if submitted 

and requested by the firm in a cover letter”.

 2.2.6 Changed IC OAA to IC BOA under second bullet point.

 2.2.6 Added to first bullet, “Cover letter is saved to the APHIS Mail Log and mailing 

information is entered. Electronic “notifications are sent.”

 2.2.6 Added to second bullet, “with the stamped legends, plot plan, and/or 

blueprints....to await the certified return receipt green card...future...”.

 2.2.7 Changed IC OAA to IC BOA

 2.2.7 Removed first bullet point 

 2.2.7 Added, “Updates the Mail Log with the date documents received by the 

establishment and the name of person who signed the Certified Mail Return Receipt,” to 

the second bullet point.

Version .03

 Moved details of each step to a more detailed work instruction

 Updated to reflect outcome of business process improvement project. 
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Version .02

 The Contact has been changed from Ronald Owen to William Huls.

 2: The location of template letters has been updated.

 2.2.3: This section has been revised to provide minor clarifications to the steps

involved.

 3: This section has been revised to further define the facilities involved in the 

process.

Version .03

 Moved details of each step to a more detailed work instruction

 Updated to reflect outcome of business process improvement project.