Signature Manifest Title: Serial Release - Extension of Dating - Process Page 1 of 1
Release Date: 07 Nov 2022 Author: RSCHNURR Document Number: CVB-WI-0117.02
CONTROLLED//PROPIN//BASIC

Signature Manifest

Document Number: CVB-WI-0117 Revision: 02
Title: Serial Release - Extension of Dating - Process
Effective Date: 07 Nov 2022

All dates and times are in Central Standard Time.

Serial Release - Extension of Dating - Process

Review for Doc Format

Name/Signature Title Date Meaning/Reason
TIANA BLANCO (TABLANCO) — Quality Management Assistant 03 Nov 2022, 01:17:42 PM Approved

Final Quality Check

Name/Signature Title Date Meaning/Reason
CROSLEY HERR (CRHERR) QA Specialist/CVB MC SME 07 Nov 2022, 01:31:51 PM Approved

Printed by: TABLANCO on 08 Nov 2022, 10:23:06 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100

file:///E:/Mastercontrol/Pub/installedServices/publishingGL V T/adlib/work/mcjobs/all/28B736218..._ 11/7/2022


Title: Serial Release - Extension of Dating - Process
Release Date: 07 Nov 2022 Author: RSCHNURR Document Number: CVB-WI-0117.02
CONTROLLED//PROPIN//BASIC

NOTE:

e Just because they request an EOD does not mean we need to grant it or grant it for
the length of dating they request. We may want to consider not granting another
full dating period. (If CVB shortens the expiration date, an audit is required with
a note stating how long will be granted for the firm to resubmit).

e Only ONE extension of dating can be allowed per serial.

e We may also consider testing the product at the CVB-Laboratory.

e We may consider adding release criteria on the serial for the firm to test at mid
and/or end of dating

10. Submit the 2008 (electronic and/or hardcopy) to the BCA for finalization.

CVB-WI-0117.02 Page 3 of 3

Printed by: TABLANCO on 08 Nov 2022, 10:23:06 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Extension of Dating - Process
Release Date: 07 Nov 2022 Author: RSCHNURR Document Number: CVB-WI-0117.02

CONTROLLED//PROPIN//BASIC

Animal and Plant . : .

Health Inspection Serial Release - Extension of Dating - Process
Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

Document Number: CVB-WI-0117 Revision: 02
Previous Number: ICWI0107.04

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 07 Nov 2022

Notes:

Printed by: TABLANCO on 08 Nov 2022, 10:23:06 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Extension of Dating - Process
Release Date: 07 Nov 2022 Author: RSCHNURR Document Number: CVB-WI-0117.02
CONTROLLED//PROPIN//BASIC

Extension of Dating — Process

Background:

Extension of expiration dating for a serial or subserial is allowed for in accordance with
title 9, Code of Federal Regulations (9 CFR), part 114.14. This is part of the regulatory
flexibility built into the 9 CFR regulations.

Most steps follow the outline as listed in CVB-SOP-0032, Processing Serial Records,
with the following additions.

Biologics Compliance Assistant (BCA) Initial Review:

1. The BCA reviews the information on the incoming APHIS Form 2008 (2008) request
(hardcopy or NCAH Portal submission) for accuracy and completeness. The CVB-FRM-
0099, Extension of Dating Worksheet (9 CFR 114.14), is used to document the review.

2. The BCA may audit the submission back in accordance with the current version of
CVB-WI-0104, Audits and Reference Slips for IC Documents, for the following reasons:
a. The proposed new date is longer than allowed for under the maximum

permitted extension;

b. Results of all potency tests for the fractions listed in the Outline of Production
(OP) are not included on the 2008 — see Section V.C. in the OP for the list of
fractions;

c. Ifthe location of the containers is not included in the submission;

d. Ifthe location of the containers is off premises and there is no letter attached
explaining why;

e. Ifthe serial has not been previously released;

f. Ifthe submission is otherwise incomplete.

3. Ifthe submission is not audited back, it should be submitted to the Specialist for
review, with the reason to Specialist as “EOD”.

a. CVB-FRM-0099 should be filled out and uploaded as an attachment

b. If hardcopy 2008 submission for the EOD, include 2008
Specialist Review:

1. Review submission in accordance with the regulations listed in 9 CFR 114.14. All
fractions must meet or exceed the potency release requirement(s) listed in the OP.

2. Review the information.
3. NOTE-EOD IS NOT GRANTED for products containing a rabies fraction.

4. Iftesting is going to be requested, contact the firm and request new samples be
submitted prior to approval of the request.

CVB-WI-0117.02 Page | of 3

Printed by: TABLANCO on 08 Nov 2022, 10:23:06 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Extension of Dating - Process
Release Date: 07 Nov 2022 Author: RSCHNURR Document Number: CVB-WI-0117.02
CONTROLLED//PROPIN//BASIC

5. Ifthe OP does not indicate that expiration dating has been confirmed for this product,
use the following guidelines when making decisions:

a. Has the product been licensed for a sufficient period of time to allow for
real-time stability data to be generated?

b. Has data been submitted to PEL and pending review?

c. Has PEL responded to a data submission requesting additional information
regarding confirmation of dating?

6. Are the fractions, in general, stable? [Yes/No] This may require communicating with
the antigen expert at the laboratory.

8. Review test results of the originally released 2008 and determine if there has been a
significant drop in potency. This is most useful with live virus titrations and live bacterial
counts but may also be beneficial in situations in which serology or relative potency is
used as the potency test.

9. Compare the number of doses requested for extension to the original released
inventory. This may provide some insight.

CVB-WI-0117.02 Page 2 of 3

Printed by: TABLANCO on 08 Nov 2022, 10:23:06 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100