CVB Inspection and Compliance Manual

CVB Inspection and Compliance Manual

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 (February 3, 2016 - 151 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     Process for Prelicensing Inspection Requests - ICWI0064 (August 30, 2016)

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     IC Pre-Inspection Packet Checklist- ICWI0041 (March 17, 2015 - 77 KB)

3.2.6     Scheduling Inspections in LSRTIS, Phase III Specialist Role - ICWI0112 (October 10, 2014 - 140 KB)

3.2.7     Inspection Items to Consider (electronic desk file on the Mail Log) - ICWI0067 (June 11, 2015 - 211 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)

3.3.3.1     Inspection Tools – Requested Documents and Observations - ICWI0035 (April 17, 2015 - 178 KB)

3.3.3.2     Inspection, Processes Observed Worksheet - ICFRM0026 (April 17, 2015 - 83 KB)

3.3.3.3     Inspection, Requested Documents Worksheet - ICFRM0027 (April 17, 2015 - 108 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 & Report Citing of 9 CFR 114.8(d) & 102.5(c)(1) - ICWI0237 (September 4, 2014 - 69 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)

3.3.9     CVB Inspection and Compliance Policy Concerning Purity Test Expectations for a Serial in Multiple Container Sizes - ICWI0050 (June 05, 2014 - 25 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     BCA Work Instructions for Processing/Finalizing Inspection Reports - ICWI0115 (October 13, 2015 – 97 KB)

3.5.2     Routing of Inspection Reports – for Specialist - ICWI0215 (October 15, 2015 – 269 KB)

3.5.3     Field Inspection Report Template

3.5.4     Inspection Report – Closing Action Items in LSRTIS - ICWI0059 (December 17, 2014 - 827 KB)

3.5.5     General Guidelines for Violations Attachment Report Format - ICWI0066 (October 29, 2015 - 78 KB)

3.6     Processing Administrative Inspection Reviews - CVBSOP0027 (June 10, 2015 - 253 KB)

3.6.1     Submittal Sheet – Administrative Inspection Review - ICFRM1004 (December 24, 2015 - 70 KB)

3.6.2     Preparation of Administrative Inspection Reviews - ICWI0242 (November 23, 2015 - 256 KB)

3.6.3     Processing Incoming Administrative Inspection Review (AIR) Documents by CVB - ICWI0241 (February 3, 2016 - 143 KB)

3.7     Biologics Forms

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

4.1     VBI Procedures - ICWI0016 (May 20, 2016 - 274 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 (May 01, 2015 - 10 KB)

4.4     Tests Requested to Assist Investigations – Processes and Responsibilities - CVBSOP0101 (May 30, 2014 - 180 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 (May 01, 2015 - 81 KB)

4.7     Veterinary Biologics Investigation Summary Sheet - ICFRM0016 (May 20, 2016 - 98 KB)

4.8     UPS Tracking of Regulatory Letters - ICWI0316 (March 16, 2016 - 89 KB)

4.9     Writing a Report of Investigation - ICWI0416 (May 18, 2016 - 140 KB)

4.10   Work Flow for Initiating a Regulatory Action or Regulatory Letter Using LSRTIS 2014 and the Mail Log System - ICWI0617 (March 09, 2015 - 168 KB)

4.11   Work Flow for Initiating a Regulatory Action or Regulatory Letter Generated from LSRTIS 2014 – Inspection Report – Using the Mail Log System - ICWI0618 (March 09, 2015 - 309 KB)

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 Form

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

5.1.3     CVB Inspection and Compliance Procedure for Generating Case Summaries from PV Works System - ICWI0128 (November 6, 2014 - 913 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 (January 10, 2014 - 263 KB)

6.2.1     Serials Ready for Conditional Action - ICFRM0010 (April 17, 2015 - 136 KB)

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

6.2.2     Processing Inventory Transfers - ICWI0310 (March 17, 2016 - 134 KB)

6.2.3     Conditional Serial Release - ICWI0410 (April 17, 2015 - 147 KB)

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

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

6.2.6     Hold Management Process for APHIS Form 2008s - ICWI0810 (November 02, 2015 - 233 KB)

6.2.6.1     Mandatory 2008 Review Document

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

6.2.8     QA Process for Serial Release - ICWI1110 (March 17, 2016 - 93 KB)

6.2.9     Log APHIS Form 2008 - ICWI1210 (November 13, 2015 - 217 KB)

6.2.10   Mock Checks in LSRTIS Phase II

6.2.11   Review Hold Release Document

6.2.12   Review of FFM 2008s for Inactivation Test Data   

6.2.13   Mail Receipt, Process, and Distribution (Student)

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

6.2.15   Process for Email Address for Electronic Notification of Serial Release

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

6.2.17   Serial Spec Sheets (formerly known as Mocks) - ICWI0057 (October 10, 2014)

6.2.18   Specialist Review Action within LSRTIS - ICWI0048 (June 16, 2016)

6.2.19   Ready for Signature Action in LSRTIS (Specialist and BCA duties) - ICWI0058 (June 15, 2016 )

6.2.20   Processing APHIS Form 2008s if Unsatisfactory Testing by the CVB and the Possible Challenge of the Test Results by the Manufacturer - ICWI0061 (February 20, 2015)

6.2.21   APHIS Dispositions and Associated Information on Form 2008s - ICWI0130 (December 18, 2015)

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

6.3.1     Rebottling Worksheet - ICFRM0006 (March 16, 2016)

6.3.2     Reprocessing Worksheet - ICFRM0007 (March 17, 2016)

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

6.4.1     Special Test Requests Initiated by Inspection and Compliance Staff - ICWI0103 (May 05, 2014)

6.5     Processing of the APHIS Form 2007 by the CVB-IC - ICSOP0035 (August 24, 2016)

6.5.1     Receiving and Updating Establishment Personnel Data - ICWI0055 (August 25, 2016)

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

6.6.1     Extension of Dating Worksheet (9 CFR 114.14) - ICFRM0107 (March 17, 2016)

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

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

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

6.8     BCA Initial Review - ICWI1310 (June 15, 2016 - 469 KB)

6.9     BCA Ready for Approval - ICWI1410 (June 15, 2016 - 603 KB) 

6.10   Processing CVB References and Reagents

6.10.1     Reference and Reagent Review and Release - CVBSOP3001 (June 05, 2015 - 133 KB)

6.10.2     Processing CVB Reference and Reagent Test Reports - ICWI3001 (January 14, 2015 - 94 KB)

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)

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

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

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

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

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

10.2     Auditing a Serial or Attaching a Reference Slip within LSRTIS - ICWI0062 (February 20, 2015)

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)

14.2     Regulatory Action Determination Worksheet 

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

14.4    CVB - IC Policy and Procedures when the Licensee/Permittee has been Granted an Animal Safety Testing Exemption Under VS Memo 800.116 - ICWI0052 (June 26, 2014)

14.5    CVB Inspection and Compliance Policy Concerning Response to Firms and the Queue Process - ICWI0328 (October 10, 2014)

15.     GENERAL OFFICE GUIDELINES

15.1     Outgoing Correspondence - ICSOP0011

15.1.1     CVB-IC Mail/Filing - ICWI0111 (August 14, 2013)

15.2     General Inspection and Compliance Correspondence Guidance - ICSOP0042 (April 4, 2016)

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

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

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

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

15.6     Program Coordinator Duties - ICWI0060 (February 6, 2015)

15.7     How to Get Inspection Site Numbers - ICWI0228 (April 06, 2016)

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     CVB Inspection and Compliance Policy Concerning Email Message Regarding Trade Secrets Act - CVBWI0215

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)

18.5     Export Information- ICWI0063 (April 02, 2015 - 128 KB)

18.6     Submitting Letter to the U.S. Department of State Office of Authentications- ICWI0065 (April 28, 2015 - 81 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 (November 06, 2015 - 154 KB)

19.2.5     Workload Indicator Calculations for Pharmacovigilance - ICWI0427

19.2.6     Workload Indicator Calculations for Imported Product - ICWI0627

19.2.7     Workload Indicator Calculations for  Policy Documents - ICWI0927

19.2.8     Workload Indicator Calculations for PC Calls - ICWI1027

19.2.9     Tracking Customer Service using LSRTIS Phone Log - ICWI0238 (February 5, 2015 - 200 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     Center for Veterinary Biologics Inspection and Compliance Training Plan - ICFRM0025 (May 6, 2013 - 26 KB)

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

19.11   Entering Potency References in LSRTIS - PIMSWI0006

19.12   Review of Quality Management Documents Related to Inspection and Compliance - ICWI0129 (May 15, 2015 - 188 KB)

 

   

 

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