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Center for Veterinary Biologics Inspection and Compliance Manual Table of Contents

Center for Veterinary Biologics Inspection and Compliance Manual Table of Contents

This policy manual represents the Center for Veterinary Biologics (CVB) current thinking on these topics.  It does not create or confer any rights for, or on any person, and does not operate to bind CVB or the public.  You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.  If you want to discuss an alternative approach, contact the CVB staff responsible for implementing these policies.

1.     INTRODUCTION

1.1     Mission

1.1.1     CVB Mission Statement

1.1.2     CVB-IC Mission Statement

1.1.3     CVB Product Monitoring Mission Statement

1.1.4     CVB Product Monitoring Strategies

1.2     History

2.     AUTHORITIES FOR THE BIOLOGICS PROGRAM

2.1     Virus-Serum-Toxin Act

2.2     VS Memo 800.1

2.3     Delegation of Authority for Center for Veterinary Biologics - Inspection and Compliance - ICSOP0001 (July 10, 2012 - 33 KB)

3.     INSPECTION OF ESTABLISHMENTS - Principles (In process)

3.1     VS Memo 800.8

3.2     Pre-Inspection Activities - ICSOP0012 (December 27, 2010 - 27 KB)

3.2.1     Requesting Special Inspections - ICWI0012 (November 25, 2009 - 13 KB)

3.2.2     Requesting International Inspections - ICWI0045 (December 2, 2013 - 81 KB)

3.2.2.1     International Inspection Checklist - ICFRM0045 (December 2, 2013 - 191 KB)

3.2.3     Pre-Inspection Blueprint Worksheet - ICFRM0001 (July 3, 2008 - 10 KB)

3.2.4     Inspection Product Check-off Sheet - ICFRM0002 (January 5, 2006 - 10 KB)

3.2.5     Performing a Query to Get a List of Last Inspection Dates by Firm and Site in AIMS/LSRTIS - ICWI0008 (November 9, 2009 - 11 KB)

3.2.6     IC Pre-Inspection Packet Checklist- ICWI0041 (March 20, 2014 - 122 KB)

3.2.7     Scheduling Inspections in LSRTIS, Phase III Specialist Role - ICWI0112 (October 26, 2011 - 8 KB)

3.3     The Inspection Proper - ICSOP0013 (August 30, 2012 - 60 KB)

3.3.1     VS Memo 800.91 (May 13 1999 - 46 KB)

3.3.2     Cross References (August 18, 2005 - 39 KB)

3.3.3     Daily Inspection Notes - ICFRM0004 (June 1, 2009 - 20 KB)

3.3.4     On-site Inspection Meeting Sign-In Sheet

3.3.5     Exemptions to 9 CFR 109.1 and 109.2 - ICWI0028 (June 12, 2013 - 80 KB)

3.3.6     Inspection Techniques to Determine Compliance with Title 9 CFR 114.8(d) - ICWI0237 (August 13, 2013 - 12 KB)

3.3.7     CVB Inspection and Compliance Policy Concerning Compliance with Title 9 CFR 114.11 and Out of Cooler Episodes - ICWI0047 (December 17, 2013 - 132 KB)

3.3.8     CVB Inspection and Compliance Policy Concerning Compliance to Title 9 CFR 113.53 - Ingredients of Animal Origin Testing - ICWI0049 (January 23, 2014 - 24 KB)

3.4     Refusal of Entry for Inspection, Assault, and Bribery Procedures - ICSOP0028 (August 25, 2009 - 283 KB)

3.4.1     Refusal of Entry Related to Inspections and Investigations - ICWI0113 (December 17, 2010 – 14 KB)

3.5     Post-Inspection Activities - ICSOP0015 (December 27, 2010 - 33 KB)

3.5.1     General Guidelines for Inspection Report Format - ICWI0015 (January 22, 2013 – 263 KB)

3.5.2     BCA Work Instructions for Processing/Finalizing Inspection Reports

3.5.3     Routing of Inspection Reports

3.5.4     Field Inspection Report Template

3.6     Processing Administrative Inspection Reviews - ICSOP0004 (December 22, 2010 - 39 KB)

3.6.1     Administrative Inspection Review Checklist- ICFRM1004 (July 18, 2011 - 67 KB)

3.7     Form Numbers (7 KB)

3.8     Sources for Blank Forms (8 KB)

4.     INVESTIGATION AND PROCESSING ALLEGED VIOLATIONS - ICSOP0016 (June 27, 2011- 459 KB)

4.1     VBI Procedures - ICWI0016 (November 9, 2011 - 666 KB)

4.2     Investigation Procedures Following a Report of Potential Lack of Efficacy Report for a Rabies Vaccine - ICWI0006 (December 12, 2013 - 135 KB) 

4.3     Nonconforming Veterinary Biological Investigation (VBI) Files - Maintenance of Work Reports - ICWI0037 (March 18, 2011 - 7 KB)

4.4     Tests Requested to Assist Investigations – Processes and Responsibilities - CVBSOP0101 (November 6, 2013 - 176 KB)

4.5     Investigation Procedures Following a Report of a Disease Outbreak in an SPF Flock which Supplies SPF Eggs or Chickens for use in Vaccine Production - ICWI0116 (February 8, 2013 - 19 KB)

4.6     Veterinary Biologics Investigation (VBI) Log - ICWI0216 (December 10, 2010 - 8 KB)

4.7     Veterinary Biologics Investigation Summary Sheet

4.8     UPS Tracking of Regulatory Letters

4.9     Preparation of Closing Report of Investigation

4.10   Investigations Module in LSRTIS

4.11   Regulatory Action Module in LSRTIS

5.     PHARMACOVIGILANCE OF VETERINARY BIOLOGICAL PRODUCTS

5.1     Receiving Adverse Event Reports at the CVB - ICSOP0017 (January 11, 2011 - 26 KB) 

5.1.1     Adverse Event Report Brochure (January 2008 - 41 KB)

5.1.2     Adverse Event Report Form (16 KB) 

5.1.3     Receiving, Entering and Filing Adverse Event Reports by the Biologics Compliance Assistant and the Biologics Epidemiologist - ICWI0117 (December 17, 2010 - 7 KB)

5.2    General Risk Analysis Process and Procedure for the CVB Pharmacovigilance Monitoring Committee - CVBSOP0020 (May 6, 2009 - 267 KB)

6.     PROCESSING SERIAL RECORDS

6.1     VS Memo 800.53 (June 27, 2014 - 124 KB)

6.2     Processing Serial Records - ICSOP0010 (July 16, 2007 - 226 KB)

6.2.1     Serials Ready for Early/Conditional Action Worksheet - ICFRM0010 (June 26, 2007 - 11 KB)

6.2.1.1     IC Release Requirements/Processing of Genetic Sequence Files for PEL

6.2.2     BCA Work Instructions for Processing Form 2008s that are “Unsat Based on Firm’s Testing” - ICWI0009 (April 6, 2011 - 38 KB)

6.2.3     Processing Inventory Transfers - ICWI0310 (September 14, 2009 - 94 KB) 

6.2.4     Early and/or Conditional Serial Release - ICWI0410 (August 27, 2010 - 20 KB)

6.2.5     APHIS Form 2008 Pen and Ink Guidance - ICWI0610 (March 18, 2011- 8 KB)

6.2.6     Unit of Measure Use and Conversion for Data Entry into LSRTIS - ICWI0710 (March 18, 2011 - 11 KB)

6.2.7     Hold Management Process for APHIS Form 2008s - ICWI0810 (May 16, 2013 - 257 KB) 

6.2.7.1     Mandatory 2008 Review Document

6.2.8     Mail Receipt, Process, and Distribution - ICWI0910 (April 4, 2013 - 38 KB)

6.2.9   QA Process for Serial Release

6.2.10   Log APHIS Form 2008

6.2.11   Mock Checks in LSRTIS Phase II

6.2.12   Review Hold Release Document  

6.2.13   Review of FFM 2008s for Inactivation Test Data    

6.2.14   Mail Receipt, Process, and Distribution (Student)

6.2.15   Information on Establishment and Product License Activity for Est. 190 and 298 Mergers

6.2.16   Process for Email Address for Electronic Notification of Serial Release

6.2.17   Receipt of Bench Records in Response to Firm Submission - ICWI0046 (December 12, 2013 - 96 KB)

6.3     Processing Requests for Rebottling/ Reprocessing - ICSOP0006 (February 1, 2010 - 51 KB)

6.3.1     Rebottling Worksheet - ICFRM0006 (September 28, 2006 - 12 KB)

6.3.2     Reprocessing Worksheet - ICFRM0007 (September 28, 2006 - 12 KB)

6.4     LSRTIS Special Test Request Procedures for Inspection and Compliance - ICSOP0043 (November 8, 2013 - 272 KB)

6.4.1     Special Test Requests in Response to Information on the APHIS Form 2008 and Associated with Risk Based Check Testing - ICWI0021 (November 25, 2009 - 9 KB)

6.5     Processing of the APHIS Form 2007 by the CVB-IC - ICSOP0035 (May 19, 2010 - 54 KB)

6.6     Extension of Dating – Biologics Compliance Assistant Procedures - ICSOP0007 (May 21, 2007 - 29 KB)

6.6.1     Extension of Dating Worksheet (9 CFR 114.14) - ICFRM0107 (December 23, 2008 - 11 KB)

6.6.2     Extension of Dating - Items for the Biologics Specialist to Consider (9 CFR 114.14) - ICWI0107 (December 17, 2010 - 11 KB)

6.7     Processing of Prelicensing Serials by Inspection and Compliance - ICSOP0025 (December 5, 2013 - 184 KB)

6.7.1     Processing of APHIS Form 2008s for Prelicensing Serials related to Firm Mergers - ICWI0042 (May 16, 2013 - 385 KB)

6.8     BCA Initial Review - ICWI1310 

6.9     BCA Ready for Approval - ICWI1410

6.10   Processing CVB References and Reagents

6.10.1     Reference and Reagent Review and Release - ICSOP3001 (April 23, 2013 - 123 KB)

6.10.2     Processing CVB Reference and Reagent Test Reports 

7.     PRODUCT SAMPLING - ICSOP0022 (May 5, 2014 - 150 KB)

7.1     Reference Slip - Product Sample Submission

8.     PRODUCT DESTRUCTION - ICSOP0005 (June 27, 2011- 115 KB)

9.     PROCESSING FACILITY DOCUMENTS - ICSOP0018 (June 17, 2013 - 30 KB)

9.1     Facility Document Worksheet - Plot Plan Preliminary Review Section (BCA) - ICFRM0018 (July 25, 2011- 16 KB)

9.2     Facility Document Worksheet - Blueprint Preliminary Review Section (BCA) - ICFRM0019 (June 14, 2013 - 90 KB)

9.3     General Guidelines on Designating a Building or Area Separate and Apart - ICWI0004 (June 12, 2013 - 8 KB)

9.4     Formulating a Blueprint Letter in Response to Facility Document Submissions - ICWI0018 (June 14, 2013 - 28 KB)

9.5     Listing Fractions in Facility Documents - ICWI0029 (April 30, 2013 - 9 KB)

9.6     Exemptions to 9 CFR Parts 109.1 and 109.2

9.7     VS Memo 800.78

10.     PROCESSING AUDITS FOR APHIS FORMS 2008 and 2071 (In process)

10.1     Approval of Alternate Form 2008 - ICWI0002

11.     INSPECTION OF A FOREIGN ESTABLISHMENT (In process)

12.     DEPOSITION, SUBPOENAS, INFORMAL CONFERENCE AND LEGISLATIVE INQUIRY PROCEDURES

12.1     Subpoena Procedures - ICSOP0024

13.     SAFETY AND HEALTH

14.     INSPECTION AND COMPLIANCE POLICIES

14.1     Compliance Policy for Issuing Regulatory Actions - ICWI0105 (October 23, 2012, 23 KB)

14.2     Regulatory Action Determination Worksheet 

14.3    APHIS Mandated Stop Distribution and Sale Procedures - ICWI0033 (March 7, 2014 - 174 KB)

15.     GENERAL OFFICE GUIDELINES

15.1     Accessing FedEx to Send Regulatory Letters – ICWI0019

15.2     Outgoing Correspondence - ICSOP0011

15.2.1     Outgoing Correspondence - ICWI0011

15.2.2     CVB-IC Mail Filing - ICWI0111 (August 14, 2013 - 15 KB)

15.3     General Inspection and Compliance Correspondence Guidance - ICSOP0042 - 25 KB (June 20, 2012)

15.3.1     Processing Freedom of Information Act (FOIA) Requests – ICWI0040

15.4     Filing Procedure Guidelines for Center for Veterinary Biologics (CVB) Inspection and Compliance (IC) and Policy, Evaluation, and Licensing (PEL) - PIMSSOP0037

15.4.1     Records Management Queue Movement in the CVB Mail Log System – PIMSSOP004

15.4.2     Movement of Mail Log Items in the Records Management Queues of the CVB Mail Log System –  PIMSWI0004.01

15.5     File Room Work Instructions

15.5.1     Steps for New Licenses (Firm or Product Codes) – PIMSWI0003.01

15.5.2     Steps for Records Management Assistant (RMA) to perform, prior to filing, when 3I (terminated products) come to Program Information Management and Security (PIMS) Record Management (RM) Area – PIMSWI0005.01

15.6     IC Documents to Archives - PIMSFRM1005

15.7     Scanning and Uploading Special Outlines and Outlines of Production to SharePoint - PIMSSOP0001

15.7.1     Scanning and Uploading to SharePoint - PIMSWI0001

15.7.2     Scanning and Uploading Labels to SharePoint - PIMSWI0002

15.7.3     Scanning and Uploading Firm Product Labels for Licensed Products - PIMSSOP0002.01

15.8     Work Flow for Correspondence for Inspection and Compliance: Using the Mail Log System - ICWI0236

15.8.1     Receipt of "Electronic Submissions" from PEL, APHIS Form 2007s and APHIS Form 2008 - ICWI0240.01

15.9     Inspection and Compliance Weekly Report to the President Examples -  ICWI0121

15.10   Posting of Quality Management Inspection and Compliance Documents - ICWI0043 (May 30, 2013 - 9 KB)

16.     REFUSAL OF ENTRY, ASSAULT AND BRIBERY PROCEDURES 

16.1     USDA Secretary’s Memorandum 4430-2 

16.2     USDA Departmental Regulation 4200-001 

16.3     USDA Handbook on Workplace Violence Prevention and Response 

16.4     APHIS Form 259-R, Workplace Incident Report 

16.5     USDA Ethics Training 

17.     GENERAL COMPUTER GUIDELINES 

17.1     In vitro Database Entry - ICWI0017 

17.2     Using the Audited 2008 Database (In process)

17.3     Outline Exceptions Database (In process)

17.4     General Guidelines for Ad Hoc Computerized Databases used by Inspection and Compliance - ICSOP0009

18.     EXPORT ACTIVITIES

18.1     Processing Certificates of Licensing and Inspection - ICSOP0029 (June 24, 2013 - 339 KB)

18.2     Processing Export Certificates - ICSOP0030 (June 19, 2013 - 188 KB) 

18.3     Creating Certificates of Licensing and Inspection in LSRTIS Phase III - ICWI0038 (May 19, 2014 - 141 KB)

18.4     Export Certificates in LSRTIS Phase III - ICWI0039 (December 20, 2011 - 20 KB)

19.     MISCELLANEOUS 

19.1     The Inspection and Compliance Review Process for Veterinary Biologics Program Documentation Intended for Publication - ICSOP0002 

19.2     Calculation and Reporting of Inspection and Compliance Workload Indicators - ICSOP0027

19.2.1     Indicator Reports from CVB Databases for Workload Indicators - ICWI012

19.2.2     Workload Indicator Calculations for On-Site Inspections - ICWI0127

19.2.3     Workload Indicator Calculations for Product Inspection - ICWI0227

19.2.4     Workload Indicator Calculations for Compliance - ICWI0327

19.2.5     Workload Indicator Calculations for Pharmacovigilance - ICWI0427

19.2.6     Workload Indicator Calculations for Exports - ICWI0527

19.2.7     Workload Indicator Calculations for Imported Product - ICWI0627

19.2.8     Workload Indicator Calculations for On-Site Inspections (QMS) - ICWI0727

19.2.9     Workload Indicator Calculations for FOIA - ICWI0827

19.2.10   Workload Indicator Calculations for  Policy Documents - ICWI0927

19.2.11   Workload Indicator Calculations for PC Calls - ICWI1027

19.2.12   Tracking Customer Service using Customer Service Database in Microsoft Access - ICWI1127 (May 16, 2013 - 158 KB)

19.3     Processing United States Veterinary Permits for Importation and Transportation of Controlled Materials and Organisms and Vectors (VS Form 16-6A MAR 95) - ICSOP0032 

19.3.1     Review, Electronic Filing, and Disposal of United States Veterinary Permit for Importation and Transportation of Controlled Materials and Organisms and Vectors (VS Form 16-6A) - ICWI0032

19.4     Center for Veterinary Biologics Inspection and Compliance Biologics Specialist Training Plan - ICFRM1001

19.5     Processing CVB Reference and Reagent Test Reports - ICWI3001 (November 16, 2011 - 15 KB)

19.6     Legal Hold Release Document - ICFRM0020 (April 11, 2014 - 11 KB)

19.7     Nonconforming Work-AIRs - ICWI0020

19.8     Training Plan for BCAs - ICFRM0021

19.9     Student File Room Training Checklist - PIMSFRM0001

19.10   Center for Veterinary Biologics Inspection and Compliance Training Plan - ICFRM0025 (May 6, 2013 - 26 KB)

19.11   U.S. OIE Annual Report for Vaccine-Related Information - ICWI0013

19.12   Entering Potency References in LSRTIS - PIMSWI0006

 

   

 



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