Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

2. Ifdocuments are to be filed with or without revisions requested, sign each
facility document — use invisible digital signature.

3. For documents that are not going to be filed, do not sign them and add a
follow-up date in the Follow-Up section of the ML. Go to 4 below

a. Select |

Building 4

Function: Preparation of bacterial veterinary biological products, QC testing, and R&D. Construction
Materials: Steel frame with exterior walls composed of concrete panels with a metal roof. Interior wal
are epoxy-painted concrete block or drywall or fiberglass reinforced paneling. Ceilings are epoxy-paint

CVB-WI-0115.03 Page 19 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03

CONTROLLED//PROPIN//BASIC

A. Apply STAMP

2. Select FY

3. On

Building 1

4. Select [I

CVB-WI-0115.03 Page 13 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

D. Add returned unprocessed to comments and click update.

Edit Attachment

Maitog tstalshment Product ode Brief Description type
a Nagano Rewssonto Sepint Bulg A 2d Moor win carespanieg summay of changes. Facy D0

‘seachmenti0
urate 2018,0814_Sub to CVE_BP Busing A 2nd Noor pal

‘ype Bluepeint ¥

Semmes curred npoonsed

os

E. Once completed, send to “Section Leader Final Authorization”.

XI. SECTION LEADER FINAL AUTHORIZATION

A. Hard copy
1. Review attachments to ensure they are complete — make sure the signed FDS
form has been scanned and uploaded. If needed, make sure the CVB-TEM-
0042 is complete.
Move Forward to “Certified Receipt” to the responsible BCA.
. If being returned unprocessed, ensure the Tag “Returned Unprocessed” is
added.

as

B. Electronic Submission - This is the final IC step prior to the ML item being
returned to the firm via the NCAH Portal.

1. Each document should be opened and reviewed to assure:
a. The proper stamp and date are shown on each page of the document.
b. There is a statement in a blue box stating “Certified by (Specialist).
c. The CVB-TEM-0044 is digitally signed by the Specialist.
d. The file name has the appropriate status (“CVB” or “REV”).

2. Ifall the documents in the ML are not being filed, then ensure the Tag
“Returned Unprocessed” is added to the ML.

3. Ifall is satisfactory, then the SL approves the ML.

4. This moves the document to records management. (See work instruction)

CVB-WI-0115.03 Page 23 of 24

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Release Date: 0:

Title: Facility Documents; Specialist Review, Including Electronic Processing
3 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

The documents should state where product is exposed to the surroundings and
therefore, there should be a higher degree of scrutiny in our review of these
areas regarding the firm’s description of how cross contamination is
mitigated.

Look at any potential negative impact R&D activities may have on
licensed/permitted product. For example, sharing of equipment, positioning of
R&D to product preparation areas, and so forth. Is the listing of Exemptions to
9 CFR 109.1 and 109.2 adequate to address concerns here?

Is the air handling system adequate in areas where product is exposed to the
surroundings for the functions performed? Assess directional airflow (e.g..
air flowing into or out of a fill suite) and air filtration (HEPA filters) for the
air supplying production rooms and compartments to make this determination.
Some questions to consider are: Is air re-circulated within a room, and what is
the turn-over rate per unit time? Do some rooms have a dedicated air supply?
Is backflow prevention necessary and if so, is it in-place?

In assessing traffic patterns, determine how personnel and materials enter
into and exit out of production rooms.

Ensure room function(s) are spelled out clearly in the blueprint legend or in
an addendum to this legend (e.g., methods to mitigate cross-contamination —
airlock function, clothes change). Often times, the room function supplied by
the firm is more like a room name. Providing an adequate description of the
room function(s) is key in determining if methods to mitigate cross
contamination are appropriate.

We have explained in the most recent VSM 800.78 what the firm should list
as equipment; however, if a document comes in with toilets shown, for
example, do not consider this as an issue in determining to accept or reject the
documents. If there are blatant errors regarding stationary equipment
identified on the blueprint or corresponding legend, inform the firm. The
documents may be sent back unfiled or result in a request for revisions.

Ifa floor drain or sink is located in a production room, do the documents
describe any backflow prevention in the drain lines to prevent the possibility
of effluent draining into the room?

This is by no means an all-inclusive list of items to consider in reviewing facility

doe!

ument submissions. If you have a question regarding the review that cannot be

found or is not clear in 9 CFR 108 or VSM 800.78, then don’t hesitate to discuss

the issue with the Facilities Manager or Inspection and Compliance (IC) Section
Leader.
CVB-WI-0115.03 Page 4 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

d. Select

<5

allowed.

f. Sign and save. See Section V and VII.C for nomenclature — should not
have to change.

g. Upload the signed document to the ML as “Outgoing Enclosures.”

h. Add the “Version #” to the Version Field on the Create Attachment
screen.

Create Attachment

Selac Fle Location © Uploaded FeO Hard Cony

Select Fle to Upload CR  ernes 25 212-600 08 Browne
SS
CVB-WI-0115.03 Page 20 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

C. Choose the tag “Returned Unprocessed — Document” and click Add.
Edit Attachment

MaiLog# Establishment ProductCode Brie Oecrption

Attachment

Durer File 2018_O614_Sub te CYB_BP_Bulng A 2nd Root pet

pent co]

Not certain which “Tag” is the correct?

C. States Returned Unprocessed but the screen shot above shows Returned
Unprocessed — Document.

Returned Unprocessed Mail tem True Ic False
Email Verification Mail tem Tue ic False
Bench Records Mail Item True Ic False
Regulatory Correspondence Mail Item True Ic False
All wholesalers and distributors Mail Item True Ic False
‘Al own persons Mail tem Tre ic False
Licensed premises Mail Item True Ic False
Regulatory Action Mail tem True c False
Pilot Project ‘Mail Item True ic True
Product Distributed Mail Item True Ic False
‘Select Agent Mail Item False Ic False
Fem Prioty Mail tem Tre ic False
Return Action Required by the Firm Mail Item True Ic False
Voluntary Stop Sale - Lift Mail Item True Ic False
Partial Voluntary Stop Sale Mail Item True Ic False
Returned Unprocessed - Document Document Twe i Te
CVB-WI-0115.03 Page 22 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

C. Name document, see Section VII.
FILED (example) Example: i BPL_Bld2_CVB
REVISIONS (example) Example: He BP Bid2_ReEV

D. Upload the stamped/dated facility document(s) to the mail log item as “IC Clean
Copy”

Most documents will move directly to Section [X Finalization at this point except
those that are unique or have policy issues/questions that the specialist determines
management review is required, if this is the case then proceed to Section VIII.

VIII. DOCUMENT REVIEW (SECTION LEADER)

Once all of the documents have been reviewed, processed, and uploaded to the ML, the
ML item will be sent to the specialist unit Section Leader (SL) for policy review.

1. The Specialist will send the ML item using “Section Leader Review(IC)”. Assign
the specialists supervisor (or designate).

CVB-WI-0115.03 Page 17 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

cross contamination

Other Other

Designation — this includes building number or addendum designation.
EXAMPLES:
A) Ifthe document is for Building 2, the designation would be “Bld2”.

ae

B) Ifthe document is addendum A, Fraction List for building 2, the
designation would be “Bld2_A”.

EE BPLA_Bld2_A_Fraction

C) Ifthe document is an addendum A, Fraction List that covers multiple
building, the designation would not include the building number in the
name but would in the comment field.

He BPLA_A Fraction
Create Attachment

MallLog# Establishment  ProductCode _Brief Description Type Date Submitted
a | Facil Documents forte. Single copy provided. Facility Document July 15, 2019
Select File Location @ Uploaded File O Hard Copy
—|
Select File to Upload ERE ocurmonts\181026.pat Browse... |
‘Type* Outgoing Enclosures {v|
Version # 2
Tags Vv) et
Bid 2- Viral
Comments

¥ Save and Add Another Document Jv Save and Return totem Record | + Cancel |

CVB-WI-0115.03 Page 9 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing

Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03

6.

10.

CONTROLLED//PROPIN//BASIC

Facility documents filed with CVB as electronic are no longer eligible for page
changes. Each submission needs to be a complete revision. The supersedes date
does not need to be applied to or assessed for correctness for each document page.
If the supersedes dates are provided, you do not need to check these against the
filed facility documents. Hard copy submissions may still utilize page changes.

For legends and addenda, evaluate the document compare report for electronic
submissions or summary of changes for hard copy submissions to determine if the
changes made are acceptable. For plot plans and blueprints, compare the summary
of changes to the documents submitted. The two should be in agreement. If not,
then contact the firm for clarification and/or return the documents unprocessed.

We will no longer be making pen-and-ink changes to the documents. Instead,
make note of items needing revision in your response back to the firm. This is for
both hard copy and electronic submissions.

a. Rule of thumb, if it was acceptable for a pen and ink change, most likely it is
appropriate to request a revision rather than send back unfiled.

b. Hard copy — questions can be asked to clarify submissions. Document the
conversation in a phone log and attach to the Mail Log (ML).

c. Electronic submissions — the Specialist can initiate a child loop, “Request info
from Submitter” with specific questions. The firm can reattach or change
documents to clarify. It is the Specialist’s responsibility to ensure the changed
documents meet the specification in 9 CFR 108 as they will not be reviewed
by the BCA.

d. Examples for clarifying questions are:
i. Information that PEL has approved the movement of organisms into a
specific area.

ii. Disinfectants used (trade names vs. active agents)

The Facility Document Submission form (FDS) is used for hard copy submissions
but is not used for electronic submissions.

. Document all revisions or reasons for returning a document on the CVB-TEM-

0042/CVB-TEM-0044. Only one template per ML should be used.
a. Upload CVB-TEM-0042 to ML as “Internally Routed” (Hard Copy).

b. Upload CVB-TEM-0044 to ML as “Outgoing General Correspondence”
(Electronic)

CVB-WI-0115.03 Page 6 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

TH. REVIEW PROCESS

1. Process facility documents in order in which they are received in your queue.
Exceptions may arise based on program priorities.

2. The Biologic Compliance Assistants (BCAs) will perform the preliminary review
of the submitted documents using CVB-WI-0109, Preliminary Review of Facility
Documents (BCA). Summary of changes will no longer be required for
electronically submitted legends and addenda (once they have been filed
electronically). Summary of changes will still be needed for those facility
documents submitted as hard copies. The BCA preliminary review includes
ensuring the documents submitted are identified correctly, the documents are
complete in accordance with 9 CFR 108 and performing a document compare
between the filed document and the submitted document for electronic
submissions. The compare document will be identified as the type “Compare
Document” and attached to the Mail Log (ML). The BCA may also attach a
document titled “Facility Document Discrepancy” that informs the Specialist of
any discrepancies identified in their preliminary review.

3. Determine if the BCA had previously audited the documents back unprocessed
and if so, were the proper correction made? Depending on the BCA’s concern(s)
noted on the Facility Document Discrepancy document, the Specialist may need
to identify those concerns on CVB-TEM-0042, Facility Document
Correspondence (hard copy), or CVB-TEM-0044, Facility Document
Correspondence (for electronic submissions). If a portal submission, the previous
ML should be informationally linked, if revisions were requested or if documents
were unprocessed. This should be done by the submitter, if not done the BCA or
Specialist can informationally link them.

4. Review the Specialist’s response to the facility documents submitted immediately
prior to the submission currently under review to see if the firm has addressed all
of the concerns previously raised. If it is determined through your review that the
overall quality of the submission is poor and/or the firm has not addressed issues
needing correction as stated in the previous facility document correspondence,
then the submitted documents may be returned unfiled along with the completed
CVB-TEM-0042/CVB-TEM-0044 form. In addition, communicate to the firm
that a regulatory action may be taken if the next facility document submission
does not provide complete and accurate information.

5. If there is to be a regulatory action based on the facility document submission,
reference the date of the previous facility document letter(s) sent to the firm. The
firm may be in violation of 9 CFR 114.1 if they have not addressed previous CVB
requests to make revisions to one or more of the facility documents.

CVB-WI-0115.03 Page 5 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

2. The SL assigned will review the documents for consistent policy. This is also an
opportunity to review the CVB-TEM-0042/CVB-TEM-0044 document, assure
the appropriate stamp has been applied to the document, and assure the file is
named in accordance with naming convention described in See Section V and
Section VII.C above.

3. After SL review there are two options.

a. Ifthe SL has determined all the documents in the ML item conform to the
process and policy, the SL will forward the ML item to the appropriate BCA
for finalization.

b. Ifthe SL has determined that items need clarified by the Specialist prior to
moving forward, the SL will make comments on the CVB-TEM-0042/CVB-
TEM-0044 and attached a revised copy to the ML item.

1) Ifthe SL determines that a further SL review of the documents is required
after the Specialist has made corrections, the SL leader would not approve
the documents when sending back to the Specialist by selecting “Cancel”
in the pop up. Ifa Specialist applied the wrong stamp, the Specialist will
need to redo the stamp. Go to edit PDF watermark. Remove. This will
remove both the stamp and date that was previously applied.

2) Ifthe SL determines that they do not need to review the documents again
after the Specialist has made corrections, the SL would approve the
documents when sending back to the Specialist. Once the Specialist makes
appropriate corrections, they send to the appropriate BCA for finalization.

IX. FINALIZATION — BCA role, CVB-WI-0113

X. SIGN CORRESPONDENCE (IC) - SPECIALIST

A. Hard copy
1. Ensure the CVB-TEM-0042 has been dated.
a. The FDS form should be “Outgoing General Correspondence
b. The CVB-TEM-0044 should be “Outgoing Enclosure”
c. The ML should be tagged “SUPPRESS Response from Portal”

2. Click on Sign Correspondence
3. Move to “Section Leader — Final Authorization”
B. Electronic Submission

1. If needed, digitally sign CVB-TEM-0044
Attach to Document Tab as “Outgoing General Correspondence”

CVB-WI-0115.03 Page 18 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

b. Primary Site - designated name, usually city location where the primary
inspection site is located for the document being reviewed. LSRTIS
classification as manufacturing, testing, quarantine.

c. Ancillary Site - designated name of the site that is associated with the primary
site. LSRTIS classification of Ancillary site. — Ancillary sites could be full
address, street name, or city. - may not be needed

d. Document Type

Document Code Building
Number
Plot Plan PP NO
Plot Plan Legend PPL NO
Plot Plan Legend Addendum PPLA NO
Plot Plan Addendum PPA NO
Blueprint BP In Name of
Document
Blueprint Legend BPL In Name of
Document
Blueprint Legend Addendum BPLA In
Comments
Blueprint Addendum BPA In Name of
Document

e. Since addendums serve a specific purpose there is a need to further identify
each addendum with the type of addendum it is below are standard
abbreviations that should be used.

Addendum Type Abbreviation

Fraction List Fraction

Decontamination Procedures Decon

Bio containment & Biosafety Practices BB

Exemptions to 9 CFR 109 109

Movement of Materials Between Licensed Movement
Premises

Storage of Master Seed off Licensed Premises MSS

Alternative Location for Storage of Records RS

Other Precaution Against Contamination CC

Most BPA and PPA are related to mitigating

CVB-WI-0115.03 Page 8 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

Electronic Document Flow
Chart

Process facility
documents first in-
first out

Review Facility
Documents using
Facility Document

Discrepancy
document and
Document Compare

Complete

Facility cVB-TEM-044 —

\o- Documents /es- revisions requested: upload to ML as
filed? “outgoing

Yes—no revisions requested conespeiiance®

Complete CvB-TEM-044 -
upload to ML as “outgoing
correspondance” and add

tag “Returned
Unprocessed” fall
documents returned

Stamp using red stamp and
date — save utilizing defined
nomenclature add “-REV" at
the end of the file name
Upload to MLas“IC Clean
Copy”

‘Stamp using black stamp and
date— save utilizing defined
nomenclature —add “-CVB" at

‘the end of the file name.
Upload to ML as “IC Clean
Copy”

Move ML to BCA for
finalization

Move ML to BCA for

fraluation
—_— Bc8's finalize per
cvB-WI-0213 and
move to specialist
for siganture
aca'sfinalze per =

cVB-WL0113 and
move to specialist
for siganture.

a:

Specialists sign
CVB-TEM-044, up
loads as “outgoing

corr” and moves ML
to Section Leader
Final Authorization

Specials san the Fcity documents and
(CVB-TEM-044 (if any) and up loads facility ia

documents to ML as “Outgoing Enclosed parealoe
‘Add version # tothe document tab and up pera tee
Toad the CV8-TEMLO8# as “Outgoing corr”

CVB-WI-0115.03 Page 24 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

Nb
Veterinary Services
FA

hott iceecen Facility Documents; Specialist Review, Including Electronic

Service Processing
Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

Document Number: CVB-WI-0115 Revision: 03

Previous Number: ICWI0086.01

Author: DMURTLE
Section/Area: CVB-WI-IC
Release Date: 03 Oct 2019
Notes:

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Author: DMURTLE Document Number: CVB-WI-0115.03

Release Date: 03 Oct 2019

CONTROLLED//PROPIN//BASIC

Make Request

Type*

Records Management Help |}

Establishment

Product

Sharepoint Site - Examples

BP_Admin_Bld1 = 1

ad BP_Bld1_Lev 2
=a BP_Bld1_Level: 2
i BP_Bld2 4
al BP_Bid2_LevelB ose 1
BP_BI 1

BP_BId7 ove 1

BP_Bld8_Necropsy1 ee 1

Bl BP BBB gAnimaizids2 3.4 a 1

CVB-WI-0115.03

Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100

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cvB

CVB

January 30
August 17, 2018

August 17, 2018

Oct

ber 16, 2018

October 16, 2018

October 16, 2018

January 30
January 30

January 30

1
Large
Animal Blds
23,4
January 30

January 30

January 30

Page 11 of 24


Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

f. Version — This will be a consecutive number for every submission of a
revision to the facility document. This first electronic submission will be
designated as Version 1. If the firm has not designated a version, the Center of
Veterinary Biologics (CVB) will designate the version of CVB’s internal
purposes. Only filed documents will receive a version number. Documents
sent back unfiled will not have a version number.

General Naming Rules —
For Version 2 and above — ALWAYS LOOK AT SHAREPOINT FOR
THE MOST CURRENT NAMING CONVENTION

1. No Building Numbers — use address for Plot Plan, Plot Plan Legend, and
Plot Plan Addendum

2. Use Building Numbers for Blueprint, Blueprint Legend, and Blueprint
Addendum

3. No Buiding Reference in Name — but listed in the comments —
Addendums (other than blueprint or plot plan drawings listed as
addendum)

4. Use the firm’s nomenclature for naming
If the blueprint is labeled as HEE Building 1, first floor the document
name should be EE. BP_Bld1_firstfloor
IF the blueprint is labeled 1* floor the document name should be

HE = BP_Bidi_1stfloor

Communication with Records Management

1. Comments to be added to sharepoint are the responsibility of the Specialist. The
Comments should only be for unique issues. You can tell by the name the document is a
blueprint (BP) so you should not add the comment blueprint. But if the blueprint is of the
entire facility (some buildings are submitted in sections) the comment should be “Entire
Facility”

2. The comments field to be used shows up when you click on “+ Create New Document
Record”. See Create Attachment above. The type of document must be Outgoing
Enclosure.

3. If you change a document name after the submission has been sent, use the Mail Log

“Make Request”. Add establishment and include the ML and changes to the document
name in brief description.

CVB-WI-0115.03 Page 10 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

DOCUMENTATION OF REVIEW OF HARD COPY DOCUMENTS

1. Center for Veterinary Biologics Inspection and Compliance Facility Document
Submission Worksheet. This form is currently under review by OMB and will be referred
to as Facility Document Submission form or FDS.
a. Complete the bottom portion of the FDS form by checking one or more of the
three boxes in Block 9, CVB Action.
Box 9.A - Documents Filed
Box 9.B - Documents Filed, Revisions Requested
Box 9.C - Documents Returned
b. Sign the form in Block 10.A. Leave Block 10.B blank as this is the date the
documents are stamped/sent back to the firm. This date will be filled in by the
BCA performing the final processing of the submission.

IV. PROCESSING OF THE FACILITY DOCUMENTS (SPECIALIST)

There will only be three possible outcomes for each facility document:

Hard Copy-FDS_| Electronic Stamp Electronic
Marked Nomenclature
Filed, No revisions Document Filed Filed with the USDA- CVB
or comments APHIS Biologics
Program
Blueprint/Legend
Filed with Revisions | Documents Filed, Filed with the USDA- REV
requested Revisions Requested | APHIS Biologics
Program
with Revisions
Requested
Blueprint/Legend
Returned, not filed | Documents Returned | No stamp Not returned
electronically

After review, the Specialist will apply the appropriate stamp and date to each electronic
document, see Section VII.

V. NOMENCLATURE FOR ELECTRONIC FACILITY DOCUMENTS

Specialist will be responsible for naming each electronic facility document attachment
using a standard convention.

Example:
Est##_ Primary Site Ancillary Site_Document Type_Designation
RE Be Bc2
Definitions:

a. EST##-—self explanatory

CVB-WI-0115.03 Page 7 of 24

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Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

i. Once all documents have been dated, signed, and uploaded, move the ML
item to “Section Leader-Final Authorization.”

4. Ifa document is not being filed, ensure the Tag “Returned Unprocessed” is added
to the document and add the comment “returned unprocessed.” This can be done
by editing the attachment as follows:

A. Click on Doc ID

20180614 Sub to CVB_BP_Building A 2nd floor.pat o7osi2018

‘Summary of Changes (Required) 2018 _0614_Sub to CVB_BP_Bullding A 2nd floor SOC pat 07/05/2018
IC Cloan Copy 196 MBM sp _2010 0614 sub to CV BP Bullding A 2nd floor-CVB.pat 07/12/2019

B. Click on Edit
Show Attachment

MsilLog# Establishment Product Code Brief Description

NAgo00 Revi to Blvepant Balding A. 2nd Hoor with comespondng summary of change
Astachment 0 a
Fite ‘Show 2018_0814_ Sub to CVB_BP_Building A_2nd floor pat
Type Blueprint
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CVB-WI-0115.03 Page 21 of 24

Printed by: CRRYAN on 10 Oct 2019, 11:19:45 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents; Specialist Review, Including Electronic Processing

Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03

CONTROLLED//PROPIN//BASIC

equipment is adequate to provide similar results. May require
technology transfer with testing by Center for Veterinary Biologics
(CVB).

New Building — new construction on a site listed on the establishment license

Remodeled Facility — construction which moves walls, areas, or an addition

Does the building require an inspection prior to filing the facility
documents?

1. Production — YES
Requires an inspection unless there are extenuating circumstances (rare).
This is at the discretion of the Section Leader (SL), Inspection.

a. New or remodeled facilities can be used AT RISK prior to an
inspection.

b. Product made in a new or remodeled facility IS NOT eligible for
consideration for marketing prior to assessment of the facility,
equipment, personnel, and processes. Samples and APHIS Form 2008s
should be held until after the inspection results are documented (unless
an inspection was not required per SL, Inspection discretion)

c. Equipment and processes should be validated prior to an inspection.

2. Testing, Distribution — depends, but can be approved without an
inspection as long as the personnel, equipment, and processes are the

same.

Revision — usually due to an update from the firm or inspection findings.

B. ITEMS TO CONSIDER WHEN REVIEWING THE FACILITY DOCUMENTS

w

Determine if there is adequate separation of production areas from non-
production areas. CVB-WI-0066, General Guidelines on Designating a
Building or Area Separate and Apart, may apply in making this
determination.

Does the level of control regarding mitigation of cross contamination appear
appropriate for the product(s) prepared? Line clearance procedures performed
in between production runs may be the primary focus for firms that
manufacture diagnostic tests, where as many safeguards against cross
contamination of licensed product should be established for injectable
vaccines.

In areas where product is exposed to the surroundings, is it clear whether
manipulations occur inside or outside of a compartment? For example, this
should be obvious in a fill suite but what about other areas, such as blending?

CVB-WI-0115.03 Page 3 of 24

Printed by: CRRYAN on 10 Oct 2019, 11:19:45 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

7. Select File and browse to find the appropriate saved stamp that should be saved
on each Specialist’s

De
a

CVB-WI-0115.03 Page 14 of 24

Printed by: CRRYAN on 10 Oct 2019, 11:19:45 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

2. Select

Building 1

a

CVB-WI-0115.03 Page 16 of 24

Printed by: CRRYAN on 10 Oct 2019, 11:19:45 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

I. BACKGROUND

The main objective in the Specialist’s review and assessment of facility document
submissions is to determine if the facility construction and arrangement, along with the
established processes and procedures regarding preparation of licensed or permitted
biological product, appear to effectively work together to ensure consistent
manufacturing of products and to mitigate contamination of licensed or permitted
product. The Specialist should become familiar with both title 9, Code of Federal
Regulations (9 CFR), part 108, and Veterinary Services Memorandum (VSM) 800.78 in
order to conduct a meaningful review. The submitted document(s) should be reviewed in
its entirety even though there may have only been a few changes.

Il. SPECIALIST REVIEW (SECONDARY REVIEW CONSIDERATIONS)

Below is a listing of some of the items each Specialist should consider when reviewing
facility documents. Keep in mind that depending on the type of licensed/permitted
product prepared at the facility and processes and procedures established to mitigate cross
contamination of product will likely differ significantly. For example, licensed
establishments preparing injectable vaccines will likely have established more safeguards
to protect product against cross-contamination than the manufacturer of diagnostic test
kits which do not require final sterility testing. In performing your review, ask yourself
the question — Does the facility appear appropriate for the intended activities and use as
described in the filed Outline(s) of Production?

A. FACILITY DOCUMENT SUBMISSION TYPE (as determined by the Specialist)
e New Address — sites not currently included on the establishment license

e  Prelicensing — self explanatory

1. Licensee — Has an APHIS Form 2001 been submitted to Policy,
Evaluation, and Licensing (PEL)?

2. Permittee — Has an APHIS Form 2005 or a special outline been submitted?
3. Diluent — Not technically required, but is site listed in a special outline?

4. Does the site require an inspection prior to adding it to the establishment

license?

a. Prelicensing — requires an inspection

b. New Address for Production — requires an inspection unless there are
extenuating circumstances. This will be at the discretion of the Section
Leader, Inspection.

c. New Address for Testing or Distribution — depends, but can be
approved without an inspection. There must be a statement from the
firm indicating the personnel are trained (if new to the process) and

CVB-WI-0115.03 Page 2 of 24

Printed by: CRRYAN on 10 Oct 2019, 11:19:45 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

Facility Documents; Specialist Review, including Electronic Processing

Source Document: Veterinary Services Memorandum 800.78 and title 9, Code of Federal Regulations, part
108

Table of Contents
I. BACKGROUND
II. SPECIALIST REVIEW (SECONDARY REVIEW CONSIDERATIONS)
Ill. REVIEW PROCESS
IV. PROCESSING OF THE FACILITY DOCUMENTS (SPECIALIST)
V. NOMENCLATURE FOR ELECTRONIC FACILITY DOCUMENTS
VI. UNPROCESSED DOCUMENTS (SPECIALIST)
VII. DOCUMENTS PROCESSED — STAMPING/DATING (SPECIALIST)
VIII. DOCUMENT REVIEW (SECTION LEADER)
IX. FINALIZATION
X. SIGN CORRESPONDENCE (IC) - SPECIALIST
XI. SECTION LEADER FINAL AUTHORIZATION

XII. Electronic Document Flow Chart

CVB-WI-0115.03 Page | of 24

Printed by: CRRYAN on 10 Oct 2019, 11:19:45 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03
CONTROLLED//PROPIN//BASIC

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VI. UNPROCESSED DOCUMENTS (SPECIALIST)
NOTE: Documents returned unprocessed will not have a Stamp, Date, or Signature
applied to the document.

A. Complete the correspondence with comments as to why the document is being
returned unprocessed.

1. Hard copy
a. Comments returned on CVB-TEM-0042. Attach document as “Internally
Routed”.

b. On FDS (hard copy), check “Documents Returned” and sign in Block 10.A.
(do not date).

2. Electronic Submission
a. Comments returned on CVB-TEM-0044. Attach document as “Internally
Routed”.
b. Unprocessed documents will not be uploaded as “IC Clean Copy”
c. Add a follow-up date that corresponds to the timeframe specified on the CVB-
TEM-0044 in the ML. Recommend 30 to 60 days.
d. Add tag “Returned Unprocessed” if the entire submission is returned.

VII. DOCUMENTS PROCESSED — STAMPING/DATING (SPECIALIST)
Documents Filed with no revisions requested or Documents Filed with revisions
requested.

CVB-WI-0115.03 Page 12 of 24

Printed by: CRRYAN on 10 Oct 2019, 11:19:45 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Facility Documents; Specialist Review, Including Electronic Processing
Release Date: 03 Oct 2019 Author: DMURTLE Document Number: CVB-WI-0115.03

CONTROLLED//PROPIN//BASIC

CVB-WI-0115.03 Page 15 of 24

Printed by: CRRYAN on 10 Oct 2019, 11:19:45 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100