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 (July 27, 2017)

3.     INSPECTION OF ESTABLISHMENTS - Principles (In process)

3.1     VS Memo 800.8

3.2     Pre-Inspection Activities - ICSOP0012 (January 18, 2017)

3.2.1     Process for Prelicensing Inspection Requests - ICWI0064 (August 30, 2016)

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

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

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

3.2.4     IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation - ICWI0041 (November 22, 2016)

3.2.5     Scheduling and Approval of Inspections in LSRTIS - ICWI0112 (October 10, 2014)

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

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

3.3.1     VS Memo 800.91 (May 13 1999)

3.3.2     Cross References (August 18, 2005)

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

3.3.3.1     Inspection Tools – Requested Documents and Observations - ICWI0035 (August 18, 2017)

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

3.3.3.3     Inspection, Requested Document Worksheet - ICFRM0027 (August 18, 2017)

3.3.3.4     Inspection Product Check-off Sheet - ICFRM0002 (January 5, 2006)

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)

3.3.6     Inspection Techniques & Report Citing of 9 CFR 114.8(d) & 102.5(c)(1) - ICWI0237 (March 28, 2017)

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)

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)

3.3.9     CVB Inspection and Compliance Policy Concerning Purity Test Expectations for a Serial in Multiple Container Sizes - ICWI0050 (June 05, 2014)

3.3.10     Evaluation of Electronic Record Keeping and Compliance with Title 9, Code of Federal Regulations, Part 116 - ICSOP0046 (June 23, 2017)

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

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

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

3.5.1     BCA Work Instructions for Processing/Finalizing Inspection Reports - ICWI0115 (October 13, 2015)

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

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

3.5.4     General Guidelines for Violations Attachment Report Format - ICWI0066 (October 29, 2015)

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

3.6.1     Preparation of Administrative Inspection Reviews - ICWI0242 (September 29, 2017)

3.6.2     Processing Incoming Administrative Inspection Review (AIR) Documents by CVB - ICWI0241 (September 29, 2017)

3.7     Biologics Forms

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

4.1     VBI Procedures - ICWI0016 (August 3, 2017)

4.2     Investigation Procedures Following a Report of Potential Lack of Efficacy Report for a Rabies Vaccine - ICWI0006 (August 4, 2017)

4.3     Nonconforming Veterinary Biological Investigation (VBI) Files - Maintenance of Work Reports - ICWI0037 (May 01, 2015)

4.4     Tests Requested to Assist Investigations – Processes and Responsibilities - CVBSOP0101 (May 30, 2014)

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)

4.6     Veterinary Biologics Investigation (VBI) Log - ICWI0216 (May 01, 2015)

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

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

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

4.10   Work Flow for Initiating a Regulatory Action or Regulatory Correspondence Using the Mail Log System and Portal - ICWI0618 (November 30, 2016)

4.11   IC Chain of Custody Form - ICFRM0108 (April 19, 2017)

5.     PHARMACOVIGILANCE OF VETERINARY BIOLOGICAL PRODUCTS

5.1     Receiving Adverse Event Reports at the CVB - ICSOP0017 (April 12, 2017)

5.1.1     Adverse Event Report Form

5.1.2     Entering and Verifying Adverse Event Reports in PV-Works - ICWI0117 (April 12, 2017)

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

5.1.4     Reviewing, Coding and Assessing Adverse Event Reports in PV-Works - ICWI0119 (April 12, 2017)

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

6.     PROCESSING SERIAL RECORDS

6.1     VS Memo 800.53 (June 27, 2014)

6.2     Processing Serial Records - ICSOP0010 (November 9, 2016)

6.2.1     Serials Ready for Conditional Action - ICFRM0010 (April 28, 2017)

6.2.2    Conditional Serial Release - ICWI0410 (April 28, 2017)

6.2.3     APHIS Form 2008 Pen and Ink Guidance - ICWI0610 (March 18, 2011)

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

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

6.2.5.1     Mandatory 2008 Review (Mock Management) in LSRTIS - ICWI0054 (May 31, 2017)

6.2.6     QA Process for Serial Release - ICWI1110 (March 17, 2016)

6.2.7     Log APHIS Form 2008 - ICWI1210 (March 14, 2017)

6.2.8     Mock Checks in LSRTIS Phase II

6.2.9     Review Hold Release Document - ICFRM0024

6.2.10   Review of FFM 2008s for Inactivation Test Data

6.2.11   Processing Inventory Transfers - ICWI0310 (March 17, 2016)

6.2.12   Extension of Dating - Process - ICWI0107 (July 6, 2017)

6.2.12.1     Extension of Dating Worksheet (9 CFR 114.14) - ICFRM0107 (January 23, 2017)

6.2.13   Rebottling - Process - ICWI0078 (January 20, 2017)

6.2.13.1     Rebottling Worksheet - ICFRM0006 (January 20, 2017)

6.2.14   Shortened Dating - Process - ICWI0131 (December 15, 2016)

6.2.15   Mail Receipt, Process, and Distribution for CVB – IC Hard Copy Submission - ICWI0910 (March 14, 2017)

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

6.2.17   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)

6.2.18   APHIS Dispositions and Associated Information on Form 2008s - ICWI0130 (July 5, 2017)

6.2.19   Audits and Reference Slips for IC Documents - ICWI0075 (September 23, 2016)

6.2.20   Items to Consider for No Tests Regarding the Wet Chick Safety Test, 9 CFR 113.207(a) - ICWI0133 (November 28, 2017)

6.3     LSRTIS Special Test Request Procedures for Inspection and Compliance - ICSOP0043 (July 10, 2017)

6.3.1     Special Test Requests Initiated by Inspection and Compliance Staff - ICWI0103 (March 22, 2017)

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

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

6.5     Processing of APHIS Form 2008s for Prelicensing Serials - ICWI0080 (April 28, 2017)

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

6.6     BCA Initial Review - ICWI1310 (March 17, 2017)

6.7     BCA Ready for Approval - ICWI1410 (July 10, 2017) 

6.8   Processing CVB References and Reagents

6.8.1     Reference and Reagent Review and Release - CVBSOP3001 (June 05, 2015)

6.8.2     Processing CVB Reference and Reagent Test Reports - ICWI3001 (January 14, 2015)

7.     PRODUCT SAMPLING - ICSOP0022 (July 5, 2017)

7.1     Reference Slip - Product Sample Submission

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

9.     PROCESSING FACILITY DOCUMENTS - ICSOP0018 (October 6, 2017)

9.1     Preliminary Review of Facility Documents (BCA) - ICWI0081 (October 12, 2017)

9.1.1     Facility Document Form Plot Plan/Plot Plan Legend - Preliminary Review (BCA) - ICFRM0018 (November 16, 2017)

9.1.2     Facility Document Form Blueprint/Blueprint Legend - Preliminary Review (BCA) - ICFRM0019 (November 16, 2017)

9.2     Facility Documents: Specialist Review and Outgoing Correspondence - ICWI0083 (October 11, 2017)

9.2.1     Facility Document Correspondence - ICTEM0045 (October 12, 2017)

9.3     Finalization of Facility Document Submission - ICWI0084 (October 31, 2017)

9.4     General Information

9.4.1     Listing Fractions in Facility Documents - ICWI0029 (October 14, 2016)

9.4.2     Exemptions to 9 CFR Parts 109.1 and 109.2 - ICWI0028 (June 12, 2013)

9.4.3     General Guidelines on Designating a Building or Area Separate and Apart - ICWI0004 (May 25, 2017)

9.4.4     Items to Consider Regarding Facility Documents for Autologous Therapeutic Biologics - ICWI0082 (September 29, 2017)

9.4.5     Items to Consider When Processing Preliminary Drawings - ICWI0132 (November 28, 2017)

9.5    VS Memo 800.78

9.5.1     OMB form (as attached to CVB Notice 17-11)

9.5.2     Directions for use of OMB form (as attached to CVB Notice 17-11)

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- ICSOP0105 (April 20, 2017)

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 (April 28, 2017)

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     Inspection and Compliance Correspondence (LSRTIS, Mail Log Procedures) - ICSOP0045 (September 1, 2016)

15.3.1     BCA Entry and Review of Incoming Correspondence - ICWI0071 (June 27, 2017)

15.3.2     Biologics Compliance Assistant (BCA) Finalization of Correspondence - ICWI0072 (September 2, 2016)

15.3.3     IC Inbox Queue - ICWI0073 (September 2, 2016)

15.3.4     Linking Documents Within the LSRTIS Mail Log System - ICWI0074 (September 1, 2016)

15.3.5     Audits and Reference Slips for IC Documents - ICWI0075 (September 23, 2016)

15.3.6     Mail Log Work Flow for Correspondence for Inspection and Compliance: Section Leader Review - ICWI0076 (September 1, 2016)

15.3.7     Mail Log Work Flow for Correspondence for Inspection and Compliance: Biologics Specialist Review - ICWI0236 (September 2, 2016)

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

15.3.9     Records Management, Quality Assurance of Inspection and Compliance Outgoing Correspondence via NCAH Portal - PIMSWI0045 (September 2, 2016)

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

15.5     Redaction Process for Inspection and Compliance Documents Posted to the CVB Website – Inspection and Compliance Manual - ICWI0043 (December 7, 2016)

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    Export Certificates and Certificates of Licensing and Inspection - ICSOP0044 (September 23, 2016)

18.2    Entry and Primary Review of Export Documents (APHIS Form 2017 and Certificates of Licensing and Inspection) - ICWI0068 (September 23, 2016)

18.3    Secondary Review of Export Documents (APHIS Form 2017 and Certificates of Licensing and Inspection) - ICWI0069 (September 21, 2016)

18.4    Finalization and Mailing of Export Documents (APHIS Form 2017 and Certificates of Licensing and Inspection) - ICWI0070 (September 20, 2016)

18.5    Export Information - ICWI0063 (November 01, 2016)

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

18.7     Audits and Reference Slips for IC Documents - ICWI0075 (September 23, 2016)

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     Workload Indicator Calculations for On-Site Inspections - ICWI0127

19.2.2     Workload Indicator Calculations for Product Inspection - ICWI0227 (November 10, 2016)

19.2.3     Workload Indicator Calculations for Compliance - ICWI0327 (November 06, 2015)

19.2.4     Workload Indicator Calculations for Pharmacovigilance - ICWI0427

19.2.5     Workload Indicator Calculations for Imported Product - ICWI0627 (April 27, 2017)

19.2.6     Workload Indicator Calculations for  Policy Documents - ICWI0927

19.2.7     Workload Indicator Calculations for PC Calls - ICWI1027

19.2.8     Tracking Customer Service using LSRTIS Phone Log - ICWI0238 (February 5, 2015)

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)

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

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)

19.10   Entering Potency References in LSRTIS - PIMSWI0006

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

 

   

 

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