Title: Serial Release - Rebottling/Reprocessing - Process

Release Date: 08 Mar 2021 Author: RSCHNURR Document Number: CVB-WI-0106.03

Health Inspection
Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

CONTROLLED//PROPIN//BASIC

Serial Release - Rebottling/Reprocessing - Process

Document Number: CVB-WI-0106 Revision: 03
Previous Number: ICWI0078.02

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 08 Mar 2021

Notes:

Printed by: CRHERR on 10 Mar 2021, 10:43:07 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Rebottling/Reprocessing - Process
Release Date: 08 Mar 2021 Author: RSCHNURR Document Number: CVB-WI-0106.03
CONTROLLED//PROPIN//BASIC

Serial Release — Rebottling/Reprocessing — Process

Source Document: Title 9, Code of Federal Regulations, part 114.17; Veterinary Services Memorandum
No. 800.62; and CVB-SOP-0032, Processing Serial Records

Background:

These requests must be submitted on an APHIS Form 2008, not via a Mail Log
Submission. Each request should have an APHIS Form 2008 for the product/serial being
rebottled/reprocessed and a letter providing details concerning the reprocessing/rebottling
process.

Rebottling of biological products is allowed for in accordance with title 9, Code of
Federal Regulations (9 CFR), part 114.17. This is part of the regulatory flexibility built
into the 9 CFR regulations. Additional guidance is found in Veterinary Services
Memorandum No. 800.62 (VSM 800.62), Relabeling, Rebottling, and Reprocessing
Veterinary Biological Products, Section V. The firm disposition on the APHIS Form
2008 request should be marked as Other - Rebottling.

Reprocessing of biological products is allowed for in accordance with 9 CFR 114.18.
This is part of the regulatory flexibility built into the 9 CFR regulations. Additional
guidance is found in VSM 800.62, Relabeling, Rebottling, and Reprocessing Veterinary
Biological Products, Section VI. A-C. The firm disposition on the APHIS Form 2008
request should be marked as Reprocess & Retest.

VSM 800.62, Section VI.D, authorizes the reprocessing of product by adding two serials
(both prepared in accordance with the filed Outline of Production) together to adjust
antigen content. This is not meant to include a serial of completed product already in
final containers. If this is requested, contact an Inspection and Compliance Section
Leader.

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

Biologics Compliance Assistant (BCA) Initial Review: Requests are shown in the
Reprocess & Retest section in BCA initial review

1. The BCA reviews the information on the incoming APHIS Form 2008 request
(hardcopy or NCAH Portal submission) for accuracy and completeness. The CVB-FRM-
0086, Serial Release — Rebottling / Reprocessing Worksheet, may be used to document
the review. The worksheet is attached to the serial record in LSRTIS, using Add
Attachment to Aphis 2008, Type is General Attachment.

2. The BCA may audit the submission back in accordance with the current version of
CVB-WI-0104, Serial Release — Audits and Reference Slips for IC Documents, if the
information required is incomplete.

3. Ifthe submission is not audited back, route it to the Specialist for review.

CVB-WI-0106.03 Page | of 2

Printed by: CRHERR on 10 Mar 2021, 10:43:07 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Serial Release - Rebottling/Reprocessing - Process
Release Date: 08 Mar 2021 Author: RSCHNURR Document Number: CVB-WI-0106.03
CONTROLLED//PROPIN//BASIC

Specialist Review: The reason for review is listed as “R&R” under the Specialist Review

1. Review submission in accordance with the regulations listed in 9 CFR 114.17 or
114.18.
a. Request should only be considered for product that has not left licensed premises.
This is a regulatory requirement for rebottling and common sense for most
reprocessing requests.
b. A letter regarding the rebottling/reprocessing procedures should include all steps
and locations where the rebottling/reprocessing will take place. Identity of materials
to be used in the reprocessing event is also beneficial.
c. The rebottled/reprocessed serial(s) must have an unique identification. This is
entered when the request is logged into LSRTIS through the NCAH portal.

2. Review the information listed on CVB-FRM-0086 and the supporting documents
submitted.
a. This may require reviewing the Outline of Production and/or the Facility
Documents.
b. Determine if the process described is detrimental to the purity of the product or
would impact product stability.

3. Rebottling or Reprocessing IS NOT GRANTED for the following:
a. Products containing a rabies fraction
b. In response to a contamination issue

4. Determine if you will require a Special Test of the NEW/rebottled serial or
NEW/reprocessed serial. See CVB-WI-0116, Special Test Requests Initiated by
Inspection and Compliance Staff for complete directions.

Sterility tests would be appropriate for rebottled serials. Sterility and/or potency tests can
be considered for reprocessed serials. If the potency test uses animals, requesting potency
testing is discouraged but not prohibited.

5. Autogenous product - If the serial to be reprocessed is from an original first serial
autogenous product, the reprocessed serial is no longer considered a first serial.

6. Provide your conclusion in LSRTIS:
Rebottling Approved
Rebottling DENIED

or

Reprocessing & Retesting Approved
Reprocessing & Retesting DENIED

6. Submit to BCA for finalization.

CVB-WI-0106.03 Page 2 of 2

Printed by: CRHERR on 10 Mar 2021, 10:43:07 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100