Title: Serial Release - BCA Initial Review

Release Date: 12 Jul 2022 Author: APJWATSON Document Number: CVB-WI-0164.03

15.

16.

17.

18.

19.

1.

CONTROLLED//PROPIN//BASIC

Rebottling — A request to rebottle a serial in accordance with 9 CFR 114.17. These
may be unreleased or released serials. If it is released serial, you may print serial stat
for the Specialist. See CVB-WI-0106, for more information.

EOD — A request to extend the dating of a serial in accordance with 9 CFR 114.14.
See CVB-WI-0117, Extension of Dating — Process, for further information.

Inactivation Testing — used for Further Manufacture products that need inactivation
testing reported to the CVB, usually killed products.

File for Information — used for when a disposition of FFI is entered, but needs to be
reviewed by the Specialist, for example, stability testing.

Other — For items that do not fit under the other categories.

If the record should be sent to Specialist review:

LSRTIS - click Specialist Review on Serial Action Sheet screen (or within the 2008
link) and select the correct item from the list of values (LOV). Click VSend to
Specialist.

Hardcopy — place in PURPLE folder for review (if applicable)
If multiple firms have Forms 2008s needing Specialist review, use separate PURPLE
folders for separate firms.

FOR HOLDS - For additional information, see Hold Management Process work
instructions (CVB-WI-0158, Hold Management Process for APHIS Form 2008s).

NOTE — Electronic Holds were instituted November 2019; therefore, newer holds
may not have a paper copy.

In general, Items C. 1-6 should go to the Specialist responsible for the firm or the
Program Coordinator (PC) if the Specialist is out for more than 24 hours.

In general, Items C. 7-19 should wait for the Specialist responsible for the firm or
investigation.

E. Auditing an APHIS Form 2008

If there is a technical error or the Form 2008 is incomplete and the information cannot be
changed or added, the Form 2008 should be audited. This can be done at any time during the
serial release process prior to signature of the Form 2008 (hard copy and LSRTIS). See CVB-
WI-0104, Audits and Reference Slips for IC Documents, within LSRTIS for the auditing process.

CVB-WI-0164.03 Page 4 of 4

Printed by: TABLANCO on 14 Sep 2022, 10:50:23 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - BCA Initial Review
Release Date: 12 Jul 2022 Author: APJWATSON Document Number: CVB-WI-0164.03
CONTROLLED//PROPIN//BASIC

If from Portal — Open the Attachment type “Portal Test Data File” for review of
Section 9 test data. Review for I/NT or comments that need Specialist Review.

6. VBI - Serials that reference a Veterinary Biologics Investigation (VBI) number
should go to the Specialist assigned to the VBI.

7. Prelicense — Serials submitted to support licensure of a product

Note: After Specialist Review, these serials will move to LSRTIS “Laboratory
Actions - Pending Licensure” until the product license is signed by CVB-PEL.

8. Process Deviation — A regulatory flexibility request by the manufacturer. The serial
was produced outside of the Outline or Standard Requirements; however, the firm has
deemed the product to be eligible for release. The Biologics Specialist, or their
Supervisor, should review the request.

9. Release Action — Some other notation or difference in the data submitted for review
on a serial that has not been marketed yet. It may include one of the following
reasons:

a. Animal test is satisfactory, but there was a death during the testing period
. Reference to a Letter, usually regarding a process deviation

c. Received with a cover letter and/or bench records
(If additional attachments are received from the Portal, the attachment type will
be labeled as “Portal Letter.”)

d. Any unusual comments in Block 11
(This will be labeled as “NCAH Portal Remarks” within the Info Section of the
2008 view.)

10. Short-dating Request — A request to market a modified live or avirulent live
lyophilized product with dating shorter than allowed in the Outline because the
potency is below release but above end-of-dating requirements. (Regulatory
Flexibility) - See CVB-WI-0130, Shortened Dating — Process, for more information.

11. Transfer Request — A request to move part or all of a released serial inventory to
another product code (and possibly another establishment in the case of mergers),
also known as the “2 leg” of a transfer. (Regulatory Flexibility)

12. Inventory Correction — If the number is significantly different or the fill/dose size
has changed, this should be sent to the specialist for review.

13. Expiration Date Correction — any time the firm needs to correct the expiration date
—not used for Extension of dating requests.

14. R&R — A request to reprocess and retest a serial in accordance with 9 CFR 114.18.
These may be unreleased or released serials. If it is released serial, you may print
serial stat for the Specialist. See CVB-WI-0106, Rebottling/Reprocessing — Process,
for more information.

CVB-WI-0164.03 Page 3 of 4

Printed by: TABLANCO on 14 Sep 2022, 10:50:23 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - BCA Initial Review
Release Date: 12 Jul 2022 Author: APJWATSON Document Number: CVB-WI-0164.03

CONTROLLED//PROPIN//BASIC

Animal and Plant . sas .
Health Inspection Serial Release - BCA Initial Review
Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

Document Number: CVB-WI-0164 Revision: 03
Previous Number: ICWI1310.04

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 12 Jul 2022

Notes:

Printed by: TABLANCO on 14 Sep 2022, 10:50:23 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - BCA Initial Review
Release Date: 12 Jul 2022 Author: APJWATSON Document Number: CVB-WI-0164.03
CONTROLLED//PROPIN//BASIC

Serial Release - BCA Initial Review

Source Document: CVB-SOP-0032, Processing Serial Records

BCA Initial Review is a step for review of data entry of the record both for the NCAH Portal and
internally entered documents received hard copy. This process is usually done between 10 a.m.
and 2 p.m.

The Biologics Compliance Assistant (BCA) will select the Serial Release within the LSRTIS
module and then select Action Sheet option. Use tab, “BCA Initial Review.”

A. View APHIS Form 2008 (Form 2008) entries by clicking on (Toggle Visibility) to open
either Primary Establishments, firms assigned to the BCA or Backup Establishments, all
other firms. The Form 2008s will be sorted based on the establishment disposition entered, then
by Firm/Product/Serial Number. The user may sort on PRTL column and Entry time stamp also.

B. Review of Form 2008 — Locate Serial to Review under Serial Action Sheet

tw opervrecord for
doxwreview

Eligible for Release:

OY — otts/2016 1521-01 989 205100 333 Audit Reference Slip
OY — otitei2016 0655-51 ‘Audit Reference Slip
oy 01/19/2016 11:30:24 Audit Reference Slip
CN ongi2016 13:11:36 Info Audit Reference Slip Specialist Review

Click on “2008” link.
1. Review Blocks 1-8 and 10-12 to ensure the submission is complete and correct; also
review the data entry for correctness.

a. Ifa 2008 is a NCAH Portal Submission (marked as Y in the PRTL column),
ensure the License Status is “Active.”

. Ensure data entered matches the specifics for the product.

c. Ensure there is a Portal Test Data File received for those Form 2008s that need
one. Mandatory for all Firm Dispositions except: File for Information, For Further
Manufacture, Inventory Correction, and Expiration Date Correction.

d. Items required on the Test Data file: (Find the firm guidance within the 2008
portal user guide, # 5 USDA APHIS | NCAH Portal User Guides)

Establishment #,

Product Code,

Serial #,

Test Reference identification,

date started and date concluded,

All test results, including validity and controls requirements, and the test
conclusion.

CVB-WI-0164.03 Page | of 4

Printed by: TABLANCO on 14 Sep 2022, 10:50:23 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - BCA Initial Review
Release Date: 12 Jul 2022 Author: APJWATSON Document Number: CVB-WI-0164.03
CONTROLLED//PROPIN//BASIC

e Also include any explanations for No Test and/or Inconclusive results.
e Expiration date of the serial is also requested.
2. Note: any referenced serial in Block 11. If the 2008s are a Portal submission, these
referenced serials may be added to the comments field in LSRTIS.

a. Ifno corrections are needed and the Form 2008 does not need to be sent to
Specialist for Review, click on “OK BCA Initial Review” — this will move the
record to 2008 Review or BCA Ready for Approval (DBF and FFM serials, for
example).

Attachments

‘Koa Attachment To Aphis 2008
‘Atachment Type
Test Attachment.docx. PortalLetter FROM PORTAL

Action History )

‘ction Employee Timestamp inte
Aphis 2008 Leggedin -NCAH-Portal NCAH-Partal 201601.27 13:06:46.8 Aphis 2008 info recelved rough NCAH Pesta: submited by Testerfive, Neah

mn en ee

b. Ifthe data entry needs to be corrected or comments added, click Ei, make

corrections, and add comment, and then click The record should remain
in BCA Initial Review.

c. Ifthe serial needs to be sent onto the Specialist but no edits are required, choose
the “Specialist Review” option within the 2008 view.

C. Determine if the Form 2008 should be sent for Specialist Review. These are in order of
importance (if two or more options are relevant, use the first applicable, in the order below).

1. Destroyed —For serials that have been destroyed by the firm.

2. Legal Hold — Mandatory that these go to the Specialist

3. Review Hold that requires specialist review as noted on the worksheet.

4. VSM 800.62 IV.D. — Any time a firm references this section of the memo for a
reprocessing Form 2008, which did not need approval from CVB to perform the

reprocessing.

5. I/NT noted in Section 9E of Form 2008

If the serial does not have an I/NT, but a related subserial has an I/NT, that would
also be sent to the specialist for review under Release Action.

CVB-WI-0164.03 Page 2 of 4

Printed by: TABLANCO on 14 Sep 2022, 10:50:23 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100