Title: Process for Prelicensing Inspection Requests (Inspection Approval and Scheduling)

Release Date: 11 Feb 2020 Author: APJWATSON Document Number: CVB-WI-5219.02
CONTROLLED//PROPIN//BASIC

‘Activity: Inspection Requests Pool

Reneowed| Yes ¥

Assigned Individual: 2]

‘Queue Entry - From: To:

‘Queue Exit - From: To: OR No Queue Exit Date]

Exit By: 4

This will give you a listing of related ML # and Status. Completed means an action has been
taken and ML has been closed. If a ML is still Active — please contact the Inspection SL.

NOTE: The requestor is not going to be in the search — but he/she will show in the
“Detailed Database Action Log.”

e> Notifications (24) Leaning Plans Searching

ts~ pdmin= — Csearn —~)iSeiarei LsenS phon | ov

too # Extnisinivnent Predict Code Et Deacon “ype Dito Suited
‘arate = got there! Inpestion lequoat September 142016

= ——<<—_a

Timestamp Action Taken User Into Attachment
09/14/2015 14.51:28, Create Mail Log Hern Ludemann, Lamy Request created

08/14/2015 14.56.17 Update Mail item Lugemann, Lamy Mail Log Item updated

ca/aanis 18.09.21 Move Item to Another Queue ‘Watson, Jeanette Mail Log ttem moved

The inspection Status can be determined by searching in LSRTIS-IC-Inspections.
1. Inspections Dashboard — Inspection Search: Enter Establishment Number and click on
Search
2. Click on Info for the inspection you are interested in.

ies

Team Team start
Est Type cation Status
Goniwee ‘ : Leader Members Date

In-Depth Denies Yeary, Teresa ——_Yeaty, Teresa; Schnurr, Renee 05/29/2012
In-Depth Completed Yeary, Teresa _Yeary, Teresa; Schnurr, Renee 05/29/2012
In-Depth Pending Inspection Koski, Danielle —_Yeary, Teresa 09/19/2016
In-Depth Cancelled Veary, Teresa (04/15/2015
In-Depth Cancelled Yeary, Teresa 04/35/2015

Special - Miscellaneous Completed Veary, Teresa Fry, Alethea 02/03/2016

3. This brings up the Show Inspection screen that includes information regarding the
inspection, including an Action History of requests, modifications, and approvals.

CVB-WI-5219.01 Page 4 of 4

Printed by: CRRYAN on 19 Feb 2020, 12:58:09 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Process for Prelicensing Inspection Requests (Inspection Approval and Scheduling)
Release Date: 11 Feb 2020 Author: APJWATSON Document Number: CVB-WI-5219.02
CONTROLLED//PROPIN//BASIC

b. The Specialist will contact the entity and schedule a time for the inspection.
i. This Phone Log will be attached to the Inspection Request ML — use hyperlink
in Recommended Inspection TAB module.
ii. The Specialist will Schedule the inspection in LSRTIS
c. The SL will approve the inspection in LSRTIS
i. The SL will place the inspection on the IC calendar under the format of
Specialist Name — Est. # (type of inspection) City, State or Country
ii, At the time of approval the Reviewer assigned to the firm will receive an email
notification.

(28/23/2016 959 AMM

Inspection approved

, over, Peul~ APHIS; ll Coe, Donel C- APHIS; Il Rippke, Byron - APHIS; I Coyle, Bonnie M APHIS; ll Schmelik Sendoge, Connie S~ APHIS; Il Yeary, Terese J~ APHIS

OF.

16. Due by Tuesday, Augus

Hello!
A Request for Inspection has been Approved!

Establishment: [i

Site: IE, \enufacturing Site
Inspection Type: Special

Special Inspection Type: Prelicensing

Travel Out Date: September 19, 2016

Lravel Back Date: September 22, 2016

Team Leader: Schnurr, Renee

Team Members:

III. Search for Inspection Request or Scheduled Inspection

Information regarding Inspection Request can be retrieved either through the ML Module or the
LSRTIS Inspection Module.

ML Module — Use Master Search in ML

1. Enter Establishment (if searching for a specific entity)
2. Enter “Inspection Requests Pool” under Activity.
3. Approved? Yes/No

CVB-WI-5219.01 Page 3 of 4

Printed by: CRRYAN on 19 Feb 2020, 12:58:09 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Process for Prelicensing Inspection Requests (Inspection Approval and Scheduling)

Release Date: 11 Feb 2020 Author: APJWATSON Document Number: CVB-WI-5219.02

Veterinary Services

Center for Veterinary
Biologics

1920 Dayton Avenue
PO Box 844
Ames, IA 50010

(15) 337-6100

CONTROLLED//PROPIN//BASIC

Process for Prelicensing Inspection Requests (Inspection Approval
and Scheduling)

Document Number: CVB-WI-5219 Revision: 02
Previous Number:

Vault: CVB-Released

Section/Area: CVB-WI-IC

Effective Date: 11 Feb 2020

Notes: This is a spin off of CVB-WI-0093 (but utilized by IC Staff)

Printed by: CRRYAN on 19 Feb 2020, 12:58:09 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Process for Prelicensing Inspection Requests (Inspection Approval and Scheduling)
Release Date: 11 Feb 2020 Author: APJWATSON Document Number: CVB-WI-5219.02
CONTROLLED//PROPIN//BASIC

IC Process for Review and Approval of Prelicensing Inspection Requests
(includes Inspection Scheduling by Specialist)

Source Document: CVB-SOP-0035, The Inspection Proper

The Center for Veterinary Biologics — Policy, Evaluation, and Licensing (CVB-PEL) requests
prelicensing inspections based on information received from the applicant. The inspection is to
determine if the personnel, facilities, equipment, and processes are appropriate for the product
considered for licensure. The request to inspect is not made by the applicant.

I. Documents required prior to approval of a prelicensing inspection:

1. APHIS Form 2001, 2003, or 2005

a. Addresses of all manufacturing, testing, and storage sites should be entered in
LSRTIS

b. Sites should be marked as Active

Draft or Final Outline of Production (OP) with PEL comments

Facility Documents

APHIS Form 2007

Summary Information Format for the Importation of Veterinary Biological Products into

the United States (for permittees only)

wae

See CVB-WI-0093 for PEL’s guidance on when to request an inspection for additional
information, if needed.

II. How to Approve a Prelicensing Inspection:

1. Inspection and Compliance Section Leader — Review Request
a. The Inspection Section Leader (SL) will be notified of a request — it is in a Tab in the
Mail Log (ML) queue, labeled Inspection Requests.
b. The ML is “self-assigned” and moved to Inspection Section Leader ML queue.
c. The request is reviewed by the SL.
i. If APPROVING -
a) Edit ML Brief Submission Description — add APPROVED and initials
b) Move ML forward to “Workflow completed — No Records Management.
Click “OK.”

CVB-WI-5219.01 Page | of 4

Printed by: CRRYAN on 19 Feb 2020, 12:58:09 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100


Title: Process for Prelicensing Inspection Requests (Inspection Approval and Scheduling)
Release Date: 11 Feb 2020 Author: APJWATSON Document Number: CVB-WI-5219.02
CONTROLLED//PROPIN//BASIC

c) The Requestor will receive an email.

ara SSM

QWReply Reply a Q

Inspection Request Updated

Wi Schnurr, Renee M ~ APHIS

Hello!

Inspection Request (ML# 176507) has been accepted by the Inspection Section Leader.
The inspection request has been placed in the recommended inspection list until it has been scheduled by Inspection and Compliance.
Comments: null

d) At approval, this will move automatically to the Recommended for
Inspection tab, and no longer show in ML queues.

e) Ifa Specialist and Biologics Compliance Assistant (BCA) are not assigned,
SL will assign and designate both roles in LSRTIS for the prelicensed entity.

iii IfDENYING-

a) Edit ML Brief Submission Description — add DENIED and initials

b) Move ML forward to “Workflow completed — No Records Management.
Click “Cancel.”

c) The Workflow Log will indicate the request was not approved.

J —————— —et—TMTF

Assigned Queue Queue Routi Return
iad Individual Entry ext xt By Approval Comment Comment
Inspection Requests Poo! 08/25/2016 14:40:48 08/25/2016 14:49:47 Schnurr, Renee

Inspection Requests Poo! Schnurr, Renee 08/25/2016 14:49:47 08/25/2016 14:51:21 Schnurr, Renee NO

Workflow completed-no records management Schnurr, Renee 08/25/2016 14:51:21 08/26/2016 1481.21

d) The SL will also discuss this action with the Reviewer who requested the
inspection. No email is sent as this should be a discussion.

Ifrequest is not complete —

a) SL will work with Reviewer and manufacturer to ensure all documents are
in order and the timing is correct for the purpose intended.

b) Once all information is complete — the SL will move through Step 3.a
above.

2. Specialist —- Schedule Inspection once it is approved by Section Leader
a. The Inspection Module will show requested info in the Recommended Inspection
TAB.
i The ML #, hyperlink to the actual ML request from PEL.
The Est #, hyperlink is a summary of the request from PEL

CVB-WI-5219.01 Page 2 of 4

Printed by: CRRYAN on 19 Feb 2020, 12:58:09 pm.
Controlled by: APHIS Center for Veterinary Biologics, 515-337-6100