Year End Report Year End Report

FY 2010

USDA, APHIS

Veterinary Services Veterinary Services

Center for Veterinary Biologics

Inspection and Compliance
Licensing, Serial Release, Testing Information System (L

LSRTIS B k d LSRTIS

Bac

kgroun

d

• Custom modules develo Custom modules develo

ped around the 

functional components of the CVB

• Retired 1 non Retired 1 non-supported application supported application

• Provides flow processing for licensing an

Provides flow processing for licensing anlicensing of over 124 veterinary biologics 

manufacturers and more than 2500 produmanufacturers manufacturers and more than 2500 produ

produ

• Provides serial release processing, tracki

Provides serial release processing, tracki

aut o at o o o e 3 o doses o h

orization f

or 

o

v

er 7

3 Billi

on doses

of 

vaccines, and related animal biologic pro

• Incorporates laboratory testing informatio

Incorporates laboratory testing informatio

f

samples or the serial release process. 
2010 LSRTIS Actions 2010 LSRTIS Actions

• LSRTIS Phase II completed and pla

LSRTIS Phase II completed completed and pla

into production

– Provides lo

g p ical 

process flow and checks for:

• Biologics Material Processing Biologics Material Processing - receiving/storing biologic samples for te

receiving/storing biologic samples for te

• Licensing Licensing • Pre-Licensing Licensing• Laboratory Testing Laboratory Testing

• Serial release tracking for vacci Serial release tracking for vaccines and other biologic materials. 

• Phase III application development in

Phase III application development in

• Certification and Accreditation Certification and Accreditation 

– Phase I C&A completed and approved. Phase I C&A completed and approved. – Phase II initiated Phase II initiated
2011 LSRTIS Actions 2011 LSRTIS Actions

• LSRTIS Phase III initiated LSRTIS Phase III initiated initiated

– Merge LSRTIS Phase I and LSRTIS Phase II developments 

Merge LSRTIS Phase I and LSRTIS Phase II developments application package. 

– Enhance Enhance application by adding: Enhance application application by adding: adding:

• Compliance Module Compliance Module – supporting compliance activities supporting compliance activities associated with v

biologics

• Inspection Module Inspection Module – supporting inspections of veterinary biologics licens

supporting inspections of veterinary biologics licens

establishments

• Export Module Export Module – supporting certification of licensed veterinary biologics 

supporting certification of licensed veterinary biologics 

exported

• Certification and Accreditation Certification and Accreditation 

– Phase II C&A to be completed and approved

Phase II C&A to be completed and approved
Pharmacovigalence (PV)

• Improve adverse event reporting and def

Improve Improve adverse adverse event reporting reporting and def

tracking of regulated biologics for USDA licensed products 

• Improve common interface for veterinary Improve common interface for veterinary 

adverse event reporting between USDA a

FD

A

• Provide CVB with a system that meets Provide CVB with a system that meets 

i il l i f internat nternational regulatory requ atory requirements rements 

for 

pharmacovigilence
2011 PV Actions 2011 PV Actions

• Commercial Off The Shelf (COTS) packa

Commercial Commercial Off The Shelf (COTS) packa

packa

purchased 

– PV Works (Vendor: Assured Information Systems) PV Works (Vendor: Assured Information Systems) – Installation of COTS Package Installation of COTS Package– User Acceptance Testing of Application User Acceptance Testing of Application– Developq y 

ment of Re ment of Requirements for an uirements for any added functiona

 added functiona

• Certification and Accreditation Certification and Accreditation

– Complete Phase I C&A Complete Phase I C&A– Initiate Phase II C&A Initiate Phase II C&A

• Development Development

I iti t t i ti t f i t f ith FDA 

– Initiate customization to prepare o prepare for interface with FDA 
Other Pharmacovigalence Pharmacovigalence Activ

Activ

• VICH Pharmacovigalence Pharmacovigalence Expert Workin

Expert Workin

– Completed work Completed work – June 2010. Additional guidance do

June 2010. Additional guidance do

published for consultation (FR published for consultation (FR Vol 75, No 204, 65293 75, No 204, 65293-

Open for comment until 21 DEC 2010 Open for comment comment until 21 DEC 2010

• Rulemaking Rulemaking 

– Will be develo Will be developg pp in new proposed rule for adverse eve

osed rule for adverse eve

reporting following VICH guidance (estimate late 2011 reporting following VICH guidance (estimate late 2011 2012)

– Final rule to be developed following comments– Delayed implementation for firms to come into complia

Delayed implementation for firms to come into complia(estimate 2016 (estimate 2016-2017) for mandatory reporting to CVB 2017) for mandatory reporting to CVB
Export Activities by Serial Export Activities by Serial

1600100012001400

600800

1000

Export C

0

200400

FY02 FY04 FY06 FY08 FY10
Export Activities by Product Export Activities by Product

4500500025003000350040001000150020002500

Certif

0

500

FY02

FY03

FY04

FY05

FY06

FY07

FY08

FY09

FY10

FY

FY

FY

FY

FY

FY

FY

FY

FY
Inspections

705060203040 

0

10

20

FY02 FY04 FY06 FY08 FY10
Special Inspections Special Inspections

20 Prelicens15

FacilitiesFacility B

10

ImmunogOther StuInvestiga

05

Select AgOther FY05 FY06 FY07 FY08 FY09 FY10
Serial Release Activities Serial Release Activities

18000120001400016000

60008000

10000

12000

Serials AuditsSerials 

0

20004000

6000 Serials 

FY00 FY02 FY04 FY06 FY08 FY10
Product Inspection Activities Product Inspection Activities

– F

90607080

Facility D

304050 Facility D

EODReproceRebottlin

0

1020

A d Rj td

Rebottlin

Approve

d

R

ejec

t

e

d
Product Inspection Activities Product Inspection Activities

350250300150200 Facility 

EODReproce

0

50

100 Rebottli

FY00 FY02 FY04 FY06 FY08 FY10
Administrative Insp (

ection Review (AIR

Activity per Year

100

6070809030405060

 Sent to FirmReceived bac

0

102030

FY

05

FY

06

FY

07

FY

08

FY

09

FY

10
Regulatory Actions Regulatory Actions

100120

Investi

406080 Opene

FormaAction

02040

Warnin

FY02 FY04 FY06 FY08 FY10
Investigations

100

804060

0

20

FY02 FY04 FY06 FY08 FY10