Title: Inspection: Pre-Inspection Activities
Release Date: 14 Oct 2022 Author: RSCHNURR Document Number: CVB-SOP-0034.04
CONTROLLED//PROPIN//BASIC

CVB-SOP-0034.04
Page 13 of 14

8.3 Additional Personal Equipment

e Flashlight
e Safety glasses

8.4 Travel Packet

Travel itinerary

Travel authorization

Government credit card

Accident report kit

State Tax Exemptions forms as applicable — links found in Concur

9. Summary of Revisions
Version CVB-SOP-0034.04
e Section 5.2.1.5 was changed to state that “The requirement to take a minimum of 30
minutes for lunch applies to travel days as well as inspection days.” Previously it
stated it did not apply.
Version CVB-SOP-0034.03

e Reviewed as a part of the Inspection Tool Kit Business Process Improvement (BPI)
project of FY2021

e Included new quality documents created in response to the BPI
Version CVB-SOP-0034.02

e The document alphanumeric number has changed from ICSOP0012.03 to CVB-SOP-
0034.02 due to the transition to MasterControl.

e Updated document numbers throughout the document and added hyperlinks to the
documents stored within MasterControl.

Version ICSOP0012.03
e¢ Complete revision of the document to reflect current practices.

e Updated work instruction numbers to reflect Master Control document numbers

Version ICSOP0012.02

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Title: Inspection: Pre-Inspection Activities
Release Date: 14 Oct 2022 Author: RSCHNURR Document Number: CVB-SOP-0034.04
CONTROLLED//PROPIN//BASIC

CVB-SOP-0034.04
Page 4 of 14

2.2 Licensing, Serial Release and Testing Information System (LSRTIS) and
Mail Log (ML)

This database system is the information management system used by CVB for listing,
scheduling, and notifying specific CVB personnel regarding on-site inspections. Non-
compliant actions, agreements, and outcomes are also stored in this database. In concert
with the ML (a document routing system used for inspection reports and related
correspondence), data can be entered and retrieved across the entire program.

Responsibilities
3.1 IC Director

The IC Director requests the funds and the manpower needed to accomplish the goals set.
The IC Director conducts domestic and international on-site inspections, especially those
related to the North American Foot and Mouth Disease Bank and National Vaccine
Stockpile.

The IC Director is responsible for the management of the Cooperative Service
Agreements for international inspections. Please confirm the travel dates and the Time
and Attendance Time Sheet when director asks at the beginning of the travel plans.
Ensure the times and travel arrangements will work for you. Consult with the travel
officials if any page stamp in your passport will present issues entering other countries.
For Example: There may be restrictions to enter the country is your passport has stamps
from other adversary countries.

3.2 Section Leader, Inspection

The Inspection Section Leader is responsible for determining the frequency of site
inspections, approval of special inspections, and providing the list of recommended
inspections each fiscal year. The Inspection Section Leader (the Compliance Section
Leader and the IC Director can serve as the Acting) is responsible for approving
requested inspections in LSRTIS. They also conduct domestic and international on-site
inspections for establishment sites and permittees assigned to them.

The Inspection Section Leader acts as the backup for drafting Cooperative Service
Agreements. Additional input may be added by Inspection Section Leader.

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Title: Inspection: Pre-Inspection Activities
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5.2 Inspection Time

5.2.1.5 The requirement to take a minimum of 30 minutes for lunch
applies to travel days as well as inspection days.

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Title: Inspection: Pre-Inspection Activities
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Page 6 of 14

4, Inspection Scheduling

41 Frequency

4.1.2 International manufacturing sites are required to be inspected on a two-
year cycle (+ 6 months).

These inspections are conducted under a Cooperative Service Agreement, in
accordance with a restriction listed on the United States Veterinary Biological
Product Permit for Distribution and Sale. The international inspections are
conducted by the IC Director, Section Leaders, or Senior Biologics Specialist
(CVB-WI-0080, Requesting International Inspections, and CVB-FRM-0097,
International Inspection Checklist).

4.1.3 Special inspections, such as prelicensing, may be requested (CVB-WI-
0093, Process for Prelicensing Inspection Requests , and CVB-WI-5219 Process
for Prelicensing Inspection Requests (Inspection Approval and Scheduling).

4.2 Scheduling and Approval of Inspections (see current version of CVB-WI-
0119)

4.2.1 Inspection priorities will be listed on the Recommended Tab in LSRTIS.
Each Specialist prepares a tentative inspection schedule for the year based upon
established priorities for the CVB program and the number assigned to each
Specialist.

4.2.2. Schedule inspections in LSRTIS as soon as possible in the fiscal year so
any gaps between work and resources can be reviewed and a plan put in place. It
is advised to avoid scheduling inspections during industry meetings such as the
Animal Health Institute (AHI) and the Association of Veterinary Biologics
Companies (AVBC) as these may be attended by firm’s Liaison and/or Alternate
Liaison.

4.2.3, Approval of domestic inspections will be done by the Inspection Section
Leader approximately three months prior to the start of the inspection. Approval
for international inspections will be done as soon as the dates are set with the
permittee.

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Title: Inspection: Pre-Inspection Activities
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3.3 Section Leaders, Senior Epidemiologists, and Senior Biologics Specialists

Section Leaders, Senior Epidemiologists, and Senior Biologics Specialists are responsible
for conducting domestic and international on-site inspections for establishment sites and
permittees assigned to them.

3.4 Biologics Specialists

Biologics Specialists are responsible for conducting domestic on-site inspections for
establishment sites assigned to them.

3.5 Investigation and Compliance Specialist

Investigation and Compliance Specialist are responsible for gathering basic data used to
prepare for on-site inspections. They are also members of domestic inspection teams.

3.6 Inspection Team Members
3.6.1 Team Leader

The Team Leader makes the final decision on assignments and ensures that all
preparatory aspects of the inspection, including review, assembly of inspection
supplies, and travel arrangements have been made for everyone on the team after
the inspection request is approved by the Section Leader of Inspections; usually
between 3 and 6 months prior to the inspection. Using the individual team
member’s reports, the Team Leader will assemble, edit, and submit the final
inspection report. The team leader needs to confirm the context of team member
items.

3.6.2 Team Member

Each team member is responsible for obtaining and evaluating the information
accumulated from the various sources and sharing that information with the rest
of the team. At the end of the inspection, each team member reports her or his
findings to the Team Leader for editing and enclosing in the final report.
Inspection notes and summaries are provided to the Team Leader within a
specified time upon returning to the office, usually within 3 days of returning to
the office.

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Title: Inspection: Pre-Inspection Activities
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Document Number: CVB-SOP-0034.04
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CVB-SOP-0034.04
Page 8 of 14

4.4.2.2 Identify special problems prior to the inspection and consider who
is best suited to research these issues.

4.4.2.3 Consider including a CVB-Laboratory scientist on the team if

testing problems are foreseen. Make requests for CVB-Laboratory
personnel to the appropriate Section Leader. Coordinate this request with

4.4.2.4 Consider including a member of CVB-Policy, Evaluation, and
Licensing (CVB-PEL) on the inspection team whenever advantageous.
Make the request to the appropriate Section Leader. Coordinate this

Travel and Time
5.1 Travel Preparation

Inspections are usually conducted at locations remote from the official duty station.

5.1.1 Domestic Inspection travel can be arranged by D&B Administration,
Travel Staff via a request sent to APHIS-CVB Admin Request email group or can
be booked by the team members in ConcurGov. The team should meet and book
the trip at the same time to ensure the same flights and hotels are reserved.

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Title: Inspection: Pre-Inspection Activities
Release Date: 14 Oct 2022 Author: RSCHNURR Document Number: CVB-SOP-0034.04
CONTROLLED//PROPIN//BASIC

nt . . ae
Health Inspection Inspection: Pre-Inspection Activities
Service

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

Document Number: CVB-SOP-0034 Revision: 04
Previous Number: ICSOP0012.03

Vault: CVB-Released

Section/Area: CVB-SOP-IC

Effective Date: 14 Oct 2022

Notes:

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Title: Inspection: Pre-Inspection Activities
Release Date: 14 Oct 2022 Author: RSCHNURR Document Number: CVB-SOP-0034.04
CONTROLLED//PROPIN//BASIC
CVB-SOP-0034.04
Page 11 of 14

7.3 Discussions with the CVB-Laboratory may also be beneficial. The detailed report
of serials will provide information to post-licensing problems that may require CVB-

7.3.2 The inspector may choose to follow CVB-SOP-5116 Records Audit to
choose records to review

7.3.3 CVB-WI-5282 Pre-Inspection Tool to provide items to consider in
evaluating compliance provides information regarding review and understanding
of an Outline of Production prior to inspection.

7.4 Facility Document Review — review the facility documents on file for the site you
are inspecting. See CVB-FRM-0082, Preinspection Blueprint Worksheet.

7.4.4.1 List the current buildings and legend pages, including the Stamp Date.

7.4.4.2 Pay special attention to addendums. Review them prior to the inspection
so you are familiar with the disinfection processes, biosecurity and biosafety
procedures in place. These are some of the observations you may make during the
initial tour of the facilities.

7.5 Final Pre-inspection Meeting

When each team member has completed their portion of the office files review and
details of scheduling, lodging, transportation, and equipment needs have been arranged,
the Team Leader may call a team meeting. The following is a checklist for the
conference:

e Redefine the objectives of the forthcoming inspection.

e Review worksheets to ensure needed information has been written down and
will be available in useful form at the inspection site.

e Review schedules, supply needs, ete.

e Answer questions.

e Go over the final work plan. Be sure everyone is aware and prepared to fulfill
their role on the inspection team.

e Anexample of items to request and initial questions can be found in CVB-
WI-5253 Inspection Tools - Items Requested During Opening Meeting -
Template

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Title: Inspection: Pre-Inspection Activities
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Page 10 of 14

6. Inspection Assignments

6.1 Tasks related to each of the major categories to be covered on an in-depth
inspection are assigned to at least one member of the team prior to the inspection.
Assignments are made by the Team Leader and are based upon the training, experience,
and expertise of each team member. Team assignments may be changed as warranted by
findings during pre-inspection review or during the inspection. Assign a mentor to team
members that are not fully trained inspectors to assure they are used efficiently and have
a productive experience. The assignment may be made ata face-to-face meeting or
through other means of communication.

6.1.1 Review the categories of inspection.
6.1.2 Set the priorities for categories to be examined during inspection.
6.1.3 Assign tasks to team member.
6.1.4 Record assignments made.
6.1.5 Discuss assignments with all team members so overlapping duties may be
coordinated.
7. Pre-Inspection Review

71 The Team Leader will either provide background documents or require each team
member to gather documents related to their assignments.

7.1.1.1 See CVB-WI-0076, IC Pre-Inspection Packet Checklist — LSRTIS
Information and Preparation. This is received as an email with attachments from
the Investigation and Compliance Specialist.

7.1.1.2 See CVB-WI-0096, Inspection Items to Consider (electronic desk file on
the Mail Log).

7.2 Discussions with the PEL-Reviewer(s) responsible for the firm site are beneficial.
The PEL-Reviewer may know of current activities relating to licenses, outlines, labels,
and research activities at the licensee.

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Title: Inspection: Pre-Inspection Activities
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4.3 Notification of Inspections

4.3.1.1 It is CVB policy for all domestic in-depth and most follow-up
inspections to be unannounced. We, therefore, limit notifications to only
those persons that need to know.

4.3.1.2 Exception to the notification restriction is possible for small firms
with limited personnel. After consulting with the IC supervisor, it may be
acceptable to contact these firms just prior to incurring travel expenses if it
is suspected that critical personnel may be away from the firm during the
inspection. Since this contact is contrary to program policy, concurrence
of the supervisor is required.

4.3.3. Pre-licensing inspections are announced. A mutually agreed upon time is
set by the Team Leader and the firm Liaison prior to scheduling the inspection in
LSRTIS.

4.3.4 Some other special inspections, such as effic
announced if notification will improve the inspection.

trials, may also be

4.3.5 International inspections are announced. A mutually agreed upon time is
set by the Team Leader and the Liaison for the permittee prior to scheduling the
inspection in LSRTIS.

4.4 The Inspection Team

4.4.1 A Biologics Specialist, Senior Biologics Specialist, Senior Epidemiologist,
Section Leader, or IC Director leads the inspection team and coordinates the
inspection. Usually, the Specialist assigned to the firm is the Team Leader, but
others may be designated this responsibility. The Team Leader assembles the
team.

4.4.2 Team Make-up
Team composition and size depends on the size of the plant, the type of

inspection, the number and types of products produced, and special problems
likely to be encountered.

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Title: Inspection: Pre-Inspection Activities

Release Date: 14 Oct 2022 Author: RSCHNURR Document Number: CVB-SOP-0034.04
CONTROLLED//PROPIN/IBASIC
CVB-SOP-0034.04
Page 3 of 14
2. Definitions
2.1 Types of Inspection

2.1.1 In-Depth

An in-depth inspection is an unannounced, detailed inspection in which overall
compliance with title 9, Code of Federal Regulations (9 CFR), and other
requirements is systematically examined. However, the Specialist should also
consult with the previous Team Leader to determine if a courtesy notification is
necessary for the firm before arrival. The time required for this type of inspection
is normally the longest of the three types of inspections but does not exceed two
weeks in length. The size of the plant, the number of inspectors on the team, and
problems encountered determine the length of time expended. As many inspection
categories as possible are examined.

2.1.2 Follow-Up

Follow-up inspections are conducted to determine if corrections required as a
result of a previous in-depth (or follow-up) inspection have been made. Need for a
“follow-up” and length of time for the inspection are recommended by the
Biologics Specialist (Specialist) based on the seriousness of the corrections
required. Follow-up inspections are discussed with the Inspection Section Leader
prior to being scheduled. Follow-up inspections are within six months from the
in-depth inspection or notification of infractions as required by 9 CFR 105.2.

2.1.3 Special

A special inspection is any inspection not of the previous two types. This type of
inspection is requested by CVB personnel or other government officials, or as
directed by the CVB-Inspection and Compliance (CVB-IC) Director. Pre=
licensing inspections, virtual inspections, remote record audits and rabies efficacy

study inspections are considered special inspections. Additional information can
be found in the quality documents listed below:

CVB-WI-5217 Prelicensing Process for Newly Establishments/Products
CVB-SOP-5113 Virtual Inspections
CVB-SOP-5116 Records Audits

CVB-WI-5283 Rabies Immunogenicity: Observation of Vaccination and
Challenge

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Title: Inspection: Pre-Inspection Activities
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Page 14 of 14

e The Contact information has been updated.

e 3.1.6: This section has been added to include Biological Compliance Inspectors as
possible inspection team members.

e 4.2: Changed timeframe from three days to five days to meet current performance
standards.

e 5.1: The method of determining inspections based on a risk-based approach is
described. This replaced the old standard of inspecting each site once every 36
months

e 8.2: Added “if assigned” to telephone credit cards since it is no longer our policy to
assign these to each new Specialist.

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Page 2 of 14

1. Purpose

An effective and productive on-site inspection starts with advanced preparation. This preparation
is key to a quality inspection of the facilities, equipment, personnel and processes for a particular
site.

Planning starts with selecting the inspection dates. The Specialist should evaluate the site that in
being inspected with the aid of previous inspections, consultation with other specialists, and with
the support of the Section Leader of Inspections to determine the number of team members, if
needed. Ifa team is required, the Team Leader should select an inspection team and consult on
best timing for the inspection. Once dates are selected, the inspection is scheduled and approved;
travel preparation can be started.

Please consider the following regarding travel preparations:

1.The Team Leader is responsible for travel reservations.
Submission of travel request is done by Team Leader and submitted to APHIS-CVB
Admin Request email address.
If done by the travelers in Concur, this activity needs to be conducted concurrently
with each team member. This is to ensure No Traveler is left without a reservation.
Not making these reservations concurrently may result in unavailability issues for
team members.

2.Determine your travel card is current and ready for use for official business expenses.
3.Before leaving for travel, ensure your travel authorization(s) is/are approved.

4.Prior to any international inspection, the traveler needs to evaluate passport expiration dates
and if a Visa or any other documentation is needed. (Work with travel staff)

Please note: There are no clear and consistent directions for international travel inspections.
The unit that determines the visa requirements is not located in Ames. The traveler needs to
know when does the documents for the Visa application and other requirements such as a
current photograph of the required size and background color are to be submitted. The
traveler must be on top of these issues even if this process is not to be conducted by him/her.
— See specific SOP and WI for International Travel

It is recommended to ensure any modification to hotel reservations for international travel do
not result in a double booking. The international hotels may not cancel your original travel
booking resulting in double billing.

Team assignments are made by the Team Leader; this can be done by product or inspection
category. Team members review the Center for Veterinary Biologics (CVB) files (hard copy and
electronic) to gather needed information for the on-site inspection. Each team member makes
sure they have the supplies needed to conduct a safe and effective inspection.

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Title: Inspection: Pre-Inspection Activities
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CVB-SOP-0034.04
Page 1 of 14

Pre-Inspection Activities

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
2. Definitions

3. Responsibilities

4. Inspection Scheduling

5. Travel and Time
6. Inspection Assignments
7. Pre-Inspection Review

8. Inspection Supplies

9. Summary of Revisions

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CONTROLLED//PROPIN//BASIC

CVB-SOP-0034.04
Page 12 of 14

8. Inspection Supplies

8.1

8.2

Computers
8.1.1 Laptop computers may be used during inspections.

8.1.2 Connecting to LSRTIS (via VPN) at the inspection location should only
be done with a government issued “hot spot.” Use of the firm’s WIFI is
discouraged, but due to connectivity may be the only means of connecting to
VPN. Always be prepared to conduct inspections without connections to LSRTIS.

8.1.3 Computers must be secured against theft or loss. Pay special attention
when going through security lines at airports as many laptop computers look the
same. If the computer is lost or stolen, call the 24-hour hotline at 1-277-744-2968
and then contact your supervisor.

Inspection Supplies

Badge and valid USDA Identification Card. Identification is always required.

Business cards

A calculator for records audit

A current 9 CFR 101-118 and other policy documents related to the inspection

with latest revisions.

A copy of the current version of CVB-SOP-0035, The Inspection Proper

e Veterinary Services Memorandum No. 800.91, Categories of Inspection for
Licensed Biologics Establishments
This information can also be found on the CVB Website under Regulations
and Regulatory Guidance.

e  Pre-printed inspection forms:

1. Daily Inspection Note Forms and Daily Notes Continuation Sheets (CVB-
FRM-0084)

2. Inspection Product Check-Off Sheet (CVB-FRM-0083)

3. Product Destruction Form (APHIS Form 2045) (CVB-SOP-0031)

4. On-site Inspection Meeting Sign-In Sheet (CVB-FRM-0085)

5. Inspection, Requested Document Worksheet (CVB-FRM-0096)

6.

7.

Inspection, Processes Observed Worksheet (CVB-FRM-0095)
Items Requested During Opening Meeting (CVB-TEM-5117)

e Blank note paper, pens, paperclips, sticky notes, highlighters, and other
stationary supplies

e  Pre-inspection packet as noted in CVB-WI-0076, IC Pre-Inspection Packet
Checklist — LSRTIS Information and Preparation and other reference material
prepared during the pre-inspection period.

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Signature Manifest Title: Inspection: Pre-Inspection Activities Page 1 of 1
Release Date: 14 Oct 2022 Author: RSCHNURR Document Number: CVB-SOP-0034.04
CONTROLLED//PROPIN//BASIC

Signature Manifest

Document Number: CVB-SOP-0034 Revision: 04
Title: Inspection: Pre-Inspection Activities
Effective Date: 14 Oct 2022

All dates and times are in Central Standard Time.

Inspection: Pre-Inspection Activities

Review for Doc Format

Name/Signature Title Date Meaning/Reason
TIANA BLANCO (TABLANCO) — Quality Management Assistant 13 Oct 2022, 11:13:46 AM Approved

Section Leader Final Approval

Name/Signature Title Date Meaning/Reason
KENDALL GRABER (KGRABER) Inspection Section Leader 13 Oct 2022, 01:23:44 PM Approved

Final Quality Check

Name/Signature Title Date Meaning/Reason
CROSLEY HERR (CRHERR) QA Specialist/CVB MC SME 14 Oct 2022, 01:56:29 PM Approved

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