Title: Product Sampling
Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0040.02
Page 4 of 9

© reserve samples from foreign facilities are maintained at the quarantine
site

4, Sample Selection

The authorized sampler should select representative containers from each market serial or
subserial according to 9 CFR 113.3 or an approved Outline of Production. This includes samples
for outline revision, samples for Master Seeds, Master Cell Stocks and serials submitted in
support of an application for a product license or permit.

Prelicensing establishments may submit samples for Master Seeds and Master Cell Stocks and
serials presented in support of an application for license or permit prior to authorization of a
sampler. In these cases, CVB-Policy, Evaluation, and Licensing may authorize a designated
employee to submit those samples. These samples may not be entered via the NCAH Portal,
unless the manufacturer has been enabled for use.

The sampler should review 9 CFR 113.3, VS Memorandum No. 800.59, and the approved
Outline of Production to ensure the correct number of samples are submitted to the Sample
Processing Section or retained by the licensee or permittee for each serial of licensed product.
The sampler should ensure that each container is correctly identified.

Note: Biologics sampling should be representative sampling in which selection is made
using a plan involving judgment factors. Random sampling, by contrast, is a statistical
technique in which each and every container in the serial would have a specified
probability of being selected. (Industrial sampling plans often incorporate both random
and systematic elements.) Biologics sampling does not usually include random selection
methods.

After sampling, the sampler must keep the samples in their possession until transferring to
another authorized sampler; placing in a secured storage area with limited access; or sealing
them in packaging for submission to the Sample Processing Section. Reserve samples should be
rendered tamper-evident and placed in a secured storage area at the recommended temperature.

4.1 Final Container Samples
The entire serial or subserial should be presented for sampling.

e Sampling should include all container sizes of the same serial in
representative proportions.

e Samples should be selected from several containers or trays in order to obtain
samples that represent different time periods of the filling process or different
locations in the lyophilizer.

e Samples from each serial or subserial should be properly identified and
secured at all times.

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


Title: Product Sampling
Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0040.02
Page 9 of 9
e 8: Updated method of notification of samplers for Sample Processing staff.

Version ICSOP0022.04

e 3.2: Updated to read, “The Specialist must use the most recent version of template
ICTEM0023, Sampler Authorization Letter.”

Version ICSOP0022.03

e Inserted updated policy under 2. Authorities

e 3.2: replaced old template letter with current QM template
Version ICSOP0022.02

e The Contact information has been updated.

e References to BMPS have been changed to the Sample Processing Section throughout
the document.

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


Title: Product Sampling

Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02
CONTROLLED//PROPIN/IBASIC
CVB-SOP-0040.02
Page 6 of 9
e The Product Code

A red check mark using permanent ink if the contents contain thimerosal

Firms should identify samples of Master Seeds and Master Cell Stocks by a unique
number or other identification which reflects the identity of material stored at the
establishment and as specified in the Outline(s) of Production.

5.2 APHIS Form 2020 (Form 2020) — required for all APHIS Submissions. See
NCAH Portal Guidance, User Guide 6, Submitting Routine Biologics Samples, for
portal submission.

See Instructions for completing a hard copy APHIS Form 2020 on the CVB
Website at
https://www.aphis.usda.gov/aphis/ourfocus/animalhealth/veterinary-

biologics/sa_bio_forms/ct_vb_forms

See NCAH Portal Guidance, User Guides 6, 7, and 8 for information
regarding portal submissions.

A completed Form 2020, Shipment and Receipt of Biologics Samples, must
accompany each shipment for each type of sample submitted to the Sample
Processing Section. Block 4 of the form must be clearly marked as to which
group is being submitted. Only one type of sample group may be listed on
each Form 2020. For example, if a firm submits routine concurrent samples
and master seeds on the same day, two Form 2020s are required.

o Routine Concurrent Samples — includes both bulk and final container
samples

o Retention Samples

o Resubmissions — for additional samples submitted in response to CVB
requests or other circumstances, including outline changes or technology
transfers special test requests. The previous sample code should be

included.

o Prelicensing Samples — samples submitted in support of a product license
or permit.

o Master Seed

o Cell Line

o Other — for stock cultures, serums, reagents, or other type not specified
above. The sample type to be specified in Block 16, Remarks.

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


Title: Product Sampling
Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0040.02
Page 5 of 9

e Bulk samples of completed product may be selected for testing as prescribed
in 9 CFR 113.3 (a)(1) and (3).
4.2 Bulk Samples
The entire serial should be presented for sampling.

The identity of the bulk should be verified by checking tags, labels, or other markings on
the tank or container in which the bulk product is held.

Agitators or mixers in the tanks or containers should be in operation for enough time to
ensure the product is completely mixed and uniform.

4.3. Serum Samples
Samplers should select, authenticate, and submit serum samples from host animal
potency tests intended for confirmatory testing according to VS Memorandum No.
800.79.
5. Proper Identification and Documentation
Each sample must be properly labeled and correspond with the accompanying paperwork.
Approved printed labels or other labels with the essential information can be used. For a
prelicensing sample, all essential information must appear on a label. All labels should be legible
and durable.

5.1 Sample Labels

Firms should properly identify each sample from a market serial or subserial with a
legible and indelible label showing:

e Producer’s name

e License or permit number

e True name of product (may be abbreviated)
¢ Serial or subserial number

¢ Volume of contents (in cc’s, mL’s, or units)
¢ Number of doses

e Expiration date, if available

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Title: Product Sampling

Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02

73

CONTROLLED//PROPIN//BASIC

CVB-SOP-0040.02
Page 8 of 9

Initials or signature should be applied across the tape surrounding the containers

or nesting cartons. Inked stamps are unacceptable.

8. Sampler Roster

Authorized samplers are listed in LSRTIS, Licensing, Establishment Employees, for a particular
firm. The Sample Processing Section should use the listing to determine if samples have been
submitted by an authorized sampler. If the firm uses the NCAH Portal for sample submission,
only those with the role of Sampler can submit via the portal.

9. Summary of Revisions

Version CVB-SOP-0040.02

Documents alphanumeric number has changes from ICSOP0022.05 to CVB-SOP-
0040.02 due to the transition to MasterControl.

Added information regarding authorized samplers at foreign manufacturing sites.

Added sentence about chain of custody.

Version ICSOP0022.05

1: Updated references to other documents.

2: Simplified authorities, removed information that can be found in the regulation
and VS Memorandum 800.59.

3.1: Added NCAH Portal.
3.2: Added requirement for sampler training on prelicensing inspections.

4: Clarified designated employee for the prelicensing establishments, as noted in VS
Memorandum 800.59.

4.1 and 4.2: Removed references about “entire” serial. Have not seen these types of
issues in the last 25 years of inspection. Uncertain what it was meant to do.

4.1; Removed “set patterns” as this may be an appropriate method to select samples
based on risk factors.

5: Product Codes should be on the sample label.

5.2: Added NCAH Portal information and updated types of samples.

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


Title: Product Sampling
Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02
CONTROLLED//PROPIN//BASIC

Veterinary Services

PS isi

Safeguarding Animal Health

holt iceeen Product Sampling
Service
Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

Document Number: CVB-SOP-0040 Revision: 02

Previous Number: ICSOP0022.05

Author: RSCHNURR
Section/Area: CVB-SOP-IC
Release Date: 13 Jan 2020
Notes:

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


Title: Product Sampling
Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0040.02
Page 7 of 9

e The data appearing on the label and on Form 2020 should agree.

e Anasterisk is to be placed in front of the product name on Form 2020 for
products containing thimerosal.

e Block 14 must be signed by an Authorized Sampler.

6. Sample Submission

6.1 Samples are to be packaged to withstand leakage of contents, shocks, pressure
changes, and other conditions incident to ordinary handling in transportation. Special care
should be taken to prevent breakage of glass containers. All vials, glass or plastic, should
be packed in nested cartons or by other methods commonly used when shipping to
distributors or consumers.

6.2 Leakage of liquid from a carton may mean refusal by a common carrier to handle
it. Damaged shipments may be destroyed by Sample Processing Section personnel upon
receipt.

6.3. The licensee is responsible for actual shipment of samples to the Sample
Processing Section.

6.4 Samples selected by the authorized sampler at the foreign manufacturing site must
be shipped in the same shipment as the salable inventory to the quarantine site.

7. Reserve Samples

Reserve samples for each serial or subserial are to “be held in a special compartment set aside by
the licensee or permittee for holding these samples under refrigeration at the storage temperature
recommended on the labels for 6 months after the expiration date.” These samples may be
requested by the government at any time (9 CFR 113.3(e)(4)). They should be tamper-evident
and held separately from the other serials or subserials in an approved secure storage area.

Rendering samples tamper-evident involves placing samples in cartons (or other containers) and
subsequently sealing the cartons so they cannot be opened or the contents disturbed without it
being obvious to the Sample Processing Section at receipt, or to a VS employee during an
inspection at the facility.

71 Samples not placed in a second container must be individually rendered tamper-
evident and the identification maintained.

7.2 Containers should be sealed with tape surrounding the container or by other
acceptable methods.

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Title: Product Sampling

Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02

CONTROLLED//PROPIN//BASIC

CVB-SOP-0040.02
Page 3 of 9

Employees at a permitted foreign site may be granted sampler authorization
privileges when the following items are considered to be met:

o Sampler authorization may be granted for employees at foreign
manufacturing sites as long as there are authorized samplers at the
quarantine site in the United States.

o Samplers at the foreign site must be located at the foreign manufacturing
site

co The sampler at the U.S. quarantine site must be located at the quarantine
site.

Negligent or deliberate disregard for proper sampling procedures is a violation
of the regulations and grounds for revocation or suspension of product and/or
establishment licenses or permits.

3.2 The Specialist

Confirm by official correspondence the authorization for a licensee or
permittee employee to be a sampler for APHIS. The Specialist must use the
most recent version of template CVB-TEM-0028, Sampler Authorization
Letter, or authorize via the Mail Log, see flowchart in CVB-WI-0086,
Appendix I.

Required to train samplers during the prelicensing inspection, regardless of
past experience by the employees.

Arrange to train new and current samplers, as necessary, during inspections.

Verify that firm personnel are using proper product sampling techniques
during inspection. The Specialist should observe that:

o. only authorized samplers are selecting samples for APHIS submission and
retention

o samples collected must be representative (see Section 4)

othe firm is correctly preparing and submitting the APHIS Form 2020 (see
Section 5)

o samples are packed appropriately for shipment (see Section 6)
othe correct number of samples is retained as reserve samples

© reserve samples are properly authenticated, labeled, rendered tamper-
evident, stored, and secured (see Section 7)

Printed by: CRRYAN on 13 Jan 2020, 11:26:48 am.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Product Sampling
Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0040.02
Page 2 of 9

1. Purpose and Scope

This document covers the procedures of sample collection, identification, and submission of
biological samples for testing by the Center for Veterinary Biologics (CVB), and the handling
and storage of Animal and Plant Health Inspection Service (APHIS) reserve samples at licensed
establishments.

The current Laboratory Resources Unit Customer Service Plan and SOP-SP-0001, Processing
Biologic Sample Submissions, covers the receipt, tracking, storage, distribution, and disposal of
samples, kits, seeds, and cells submitted to CVB for testing. The current version of CVB-SOP-
0045, Processing of the APHIS Form 2007 by the Center for Veterinary Biologics-Inspection
and Compliance, addresses the processing of APHIS Form 2007 for Authorized Samplers.

2. Authority

Title 9, Code of Federal Regulations (9 CFR), section 113.3, states “each licensee and permittee
shall furnish representative samples of each serial or subserial of a biological product
manufactured in the United States or imported into the United States as prescribed in this
section.” Veterinary Services (VS) Memorandum No. 800.59 established the policies and
procedures for selecting, authenticating, and submitting veterinary biological product samples for
testing by the CVB or for retention for APHIS.

3. Roles and Responsibilities
3.1. Authorized Samplers

Collection of biologics samples is performed either by an employee of the United States
Department of Agriculture (USDA), VS, or by an employee of the licensee or permittee
who has been authorized by CVB to collect and handle biologics samples.

e The employee must be trained by a person familiar with sampling procedures
according to 9 CFR 113.3,VS Memorandum No. 800.59 and (when
applicable) VS Memorandum 800.101 in order to be an authorized sampler.

e Firms must submit an APHIS Form 2007, Qualifications of Veterinary
Biologics Personnel, to the CVB for each person the firm requests to become
an authorized sampler. In addition, the firm must request sampler
authorization in writing (formal correspondence) or via the NCAH Portal.

e The sampler must be located at a site listed on the establishment license.

e The chain of custody records for the samples is the responsibility of the
licensee or the permittee.

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


Title: Product Sampling
Release Date: 13 Jan 2020 Author: RSCHNURR Document Number: CVB-SOP-0040.02
CONTROLLED//PROPIN//BASIC

CVB-SOP-0040.02
Page 1 of 9
Product Sampling

Mention of trademark or proprietary product does not constitute a guarantee or warranty of the product by USDA
and does not imply its approval to the exclusion of other products that may be suitable.

Table of Contents
1. Purpose and Scope

2. Authority

3. Roles and Responsibilities

4. Sample Selection

5. Proper Identification and Documentation
6. Sample Submission

7. Reserve Samples

8. Sampler Roster

9. Summary of Revisions

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