Title: Serial Release - BCA Ready for Approval
Release Date: 08 Mar 2022 Author: APJWATSON Document Number: CVB-WI-0165.03
CONTROLLED//PROPIN//BASIC

2. Ensure the hardcopy Audit form is printed out, if needed. This can be found under the
2008 link, under the Attachments subheading, Aphis2044, or PDF link within Audit
Actions subheading.

Serial Action Sheet

{ ed oe Cd T T es

Primary Establishments(50):

Initial

stapnsnment Dispostuon Ligne te Reesse
Rectved Date ‘w2e2014
Expiration Date oansi2016
sonal tas actee
Doses 294225 Doses
Aurogonous? No

Fst Sedat? No
Fity Or Less Vials? No
Comments

Attachments

‘kod Atachment To Aphis 2008

‘Apbie2044

Action History

‘action Timestamp Into
‘Ais 2008 Logged in
Inwaly Renewed
2008 Revew - Net Reviewed

‘Aphis 2008 Update

Audit Actions
Action Employee Timesta ‘Audit Reason ‘Aut Comments
ght 2008 Ausiog Watson. Janete 2015-07-13 1258420 valid EpNaton Dale test POF EDIT

F. Stability Test Reports — see work instruction Stability Tests Reports from the CVB Lab,
CVB-WI-5227 on processing these

NOTE

* If a serial should be at the BCA Ready for Approval step, but is stuck within the Lab Actions
(will be in the Subserials subheading), contact a System Administrator — a person with this access
can run the overnight job which moves these serials on if all criteria have been met.

CVB-WI-0165.03 Page 4 of 4

Printed by: CRHERR on 14 Mar 2022, 01:24:37 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - BCA Ready for Approval
Release Date: 08 Mar 2022 Author: APJWATSON Document Number: CVB-WI-0165.03
CONTROLLED//PROPIN//BASIC

C. Rejected

Ifa serial should not be released for a variety of reasons, the Specialist can push the serial to
Rejected.

The BCA needs to edit the serial in tab BCA Ready for Approval and add note as to why prior to
pushing it to the Specialist to reject.

1. Click on 2008

2. Click on Edit

3. Add note in Comments

The Specialist should then click on Reject and the serial goes back to BCA Ready for Approval in
the reject section.

Serial Action Sheet

APHIS 2008152,374updoted

SVE IT |

D. Audits

If a Form 2008 has been audited by either the Specialist or the BCA, it will be directed to the
BCA Ready for Approval. Refer to CVB-WI-0104, Serial Release - Audits and Reference Slips
for IC Documents, for processes on auditing a serial. If received from the Portal, no printing is
required.

1. Form 2008s that were audited in the Serial Release process will show “Audited” in the
action sheet (shown below).

Serial Action Sheet

APMIS 2008 182,352 upaated

[ ey ery ry <7 | im
Primary Establishments(50):

Cloaate Visibitiny)

Initial

Not tobe Testes ‘Audited i
Nott be Tested Audit f

CVB-WI-0165.03 Page 3 of 4

Printed by: CRHERR on 14 Mar 2022, 01:24:37 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - BCA Ready for Approval
Release Date: 08 Mar 2022 Author: APJWATSON

CONTROLLED//PROPIN//BASIC

Animal and Plant

Health Inspection Serial Release - BCA Ready for Approval

Service

Document Number: CVB-WI-0165.03

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

Document Number: CVB-WI-0165 Revision: 03
Previous Number: ICWI1410.04

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 08 Mar 2022

Notes:

Printed by: CRHERR on 14 Mar 2022, 01:24:37 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - BCA Ready for Approval
Release Date: 08 Mar 2022 Author: APJWATSON Document Number: CVB-WI-0165.03
CONTROLLED//PROPIN//BASIC

Serial Release - BCA Ready for Approval

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

All APHIS Form 2008s (Form 2008s) will be assembled by the Biologics Compliance Assistants
(BCAs) at BCA Ready for Approval tab in the process (including Audits) for a final review and
processing of the paperwork prior to signature. This includes printing out test reports, stamping
the Form 2008s with the appropriate APHIS Disposition, the title of the signatory and the date,
and performing a final quality check for completeness of the document, if received hard copy.

If the 2008 information is received from the NCAH Portal, the Ready for Approval Process is
used for a quality check of the APHIS Disposition.

This process is usually done after BCA arrival through 9:30 a.m.
A. Serial Release Process

The BCA will select the Serial Release within the LSRTIS module and then select Action Sheet
option. Use the tab, “BCA Ready for Approval.”

1. View Form 2008 entries by clicking on (Toggle Visibility) to open either Primary
Establishments for firms assigned to the BCA or Backup Establishments for all other firms
within the Initial group. The Form 2008s will be sorted on Initial or Rejected.

* Rejected is a parking lot for serials that have issues or questions to be answered but have
moved through the rest of the process (see Section D). All employees have access to
reject a serial. But note, it will continue to move to this area in BCA Ready for Approval
if not signed in the subsequent step.

2. The serial records listed under Initial are the serials that are eligible for release,
completion of a firm request, or acknowledgment of information received.

f rs Ce Ce =| T

Primary Establishments(0):

(Toggle Visi)

Backup Establishments(24):

(Toggle Visi)

Initial

Y  oaoanie

WEAR Nottobe Tested ‘ut Reference Sin ‘SpacinistReview 2008 / Sail Sat
Yanna

CVB-WI-0165.03 Page | of 4

Printed by: CRHERR on 14 Mar 2022, 01:24:37 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - BCA Ready for Approval
Release Date: 08 Mar 2022 Author: APJWATSON Document Number: CVB-WI-0165.03
CONTROLLED//PROPIN//BASIC

B. Processing Form 2008s

Match the hard copy Form 2008 to the list under BCA Ready for Approval. (At the point the
NCAH Portal is utilized, a hard copy Form 2008 may not be present.)

The BCA may click on Serial Stat link to verify no testing was done.

Process hard copy Form 2008 by doing the following:
1. Check APHIS Disposition box (Block 16) — see CVB-WI-0129 for dispositions
2. Stamp title (Block 18)
3. Stamp the date (Block 19)
4. Stamp/type any additional release info in Block 16 if applicable

Process electronic Form 2008 (from Portal) by:
1. Ensure the APHIS Disposition is correct
2. Determine if the CVB Testing matches the APHIS Disposition
3. Check Audits and/or Reference slips are complete
4. Ensure the release criteria that may be added is complete and accurate

Click on Serial to move it forward. This can be done in batches or within the 2008 view link. If

v Approve Selected

If the serial has been tested, click on Test Report link (which will show in the column between
APHIS Disposition and Audit), print two copies if received hard copy, and staple one copy to the
original and the other to the firm’s copy of the Form 2008. No printing is needed if the
information was received from the Portal.

done in batches, click on at the bottom of the page.

If there is a No Test or Inconclusive on the Test Report, click on the serial stat, scroll down to the
Testing area to see if there are any comments the lab has entered that gives you more information
about the test results the lab determined. Make sure to check all the test results if there are more
than one test result. If you have questions about the lab results, check with the Product Manager
or Specialist for that firm before moving that serial forward.

If the test results were unsatisfactory, the serial should be moved forward to Specialist Review,
see CVB-WI-0091 for detailed instructions.

REMINDER ~ any serial received hardcopy that is unacceptable for marketing should be stamped
and signed in RED. This includes:

1. Serials tested unsatisfactory by CVB

2. Serial unsatisfactory based on the firm’s test results

3. Serials destroyed by the firm

Give all hard copy Form 2008s for Specialist Signature to the Program Coordinator. However,

there are a few APHIS Dispositions that can be signed by the BCA. See CVB-WI-0088, Serial
Release - Ready for Signature Action in LSRTIS (Specialists and BCA Duties), for Form 2008s

for this list.

CVB-WI-0165.03 Page 2 of 4

Printed by: CRHERR on 14 Mar 2022, 01:24:37 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100