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• Biologics Regulations & Guidance

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

• Mission


• CVB Mission Statement


• CVB-IC Mission Statement


• CVB Product Monitoring Mission Statement


• CVB Product Monitoring Strategies

• History

2.     AUTHORITIES FOR THE BIOLOGICS PROGRAM

• Virus-Serum-Toxin Act


• VS Memo 800.1


• Delegation of Authority for Center for Veterinary Biologics - Inspection and Compliance ICSOP0001 (July 27, 2017)

3.     INSPECTION OF ESTABLISHMENTS - Principles (In process)

• VS Memo 800.8


• Pre-Inspection Activities CVB-SOP-0034 (April 1, 2020)
  

• Process for Prelicensing Inspection Requests CVB-WI-0093 (February 11, 2020)


• Requesting International Inspections CVB-WI-0080 (December 14, 2018)


• International Inspection Checklist ICFRM0045 (December 2, 2013)
  

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

• IC Pre-Inspection Packet Checklist - LSRTIS Information and Preparation CVB-WI-0076 (September 10, 2020)


• Scheduling and Approval of Inspections in LSRTIS CVB-WI-0119 (July 12, 2019)


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

• The Inspection Proper ICSOP0013 (August 30, 2012)    
  

• VS Memo 800.91 (May 13 1999)


• Cross References (August 18, 2005)
  


• Daily Inspection Notes CVB-FRM-0084 (June 1, 2009)
  

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


• Inspection, Processes Observed Worksheet ICFRM0026 (April 17, 2015)


• Inspection, Requested Document Worksheet ICFRM0027 (August 18, 2017)


• Inspection Product Check-off Sheet CVB-FRM-0083 (January 13, 2020)
  

• On-site Inspection Meeting Sign-In Sheet


• Exemptions to 9 CFR 109.1 and 109.2 ICWI0028 (June 12, 2013


• Inspection Techniques & Report Citing of 9 CFR 114.8(d) & 102.5(c)(1) ICWI0237 (July 26, 2018)


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


• CVB Inspection and Compliance Policy Concerning Compliance to Title 9 CFR 113.53 - Ingredients of Animal Origin Testing CVB-WI-0083 (August 11, 2021)


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

• Items to Consider in Evaluating Electronic Records and Digital Data ICWI0146 (December 01, 2017)
  

• Assessing Compliance with the Requirement of State Veterinarian Approval CVB-WI-5215 (January 2, 2020)

• Refusal of Entry for Inspection, Assault, and Bribery Procedures - ICSOP0028
  

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

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

• BCA Process for Finalization of Inspection Reports CVB-WI-0121 (April 1, 2020)


• Routing of Inspection Reports – for Specialist CVB-WI-0136 (August 11, 2021)


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


• General Guidelines for Violations Attachment Report Format CVB-WI-0095 (August 20, 2021)
  

• Processing Administrative Inspection Reviews CVB-SOP-0028 (November 4, 2019)
  

• Preparation of Administrative Inspection Reviews CVB-WI-0145 (March 8, 2022)


• Processing Incoming Administrative Inspection Review (AIR) Documents by CVB CVB-WI-0144 (March 8, 2022)
  

• Biologics Forms
  

4.     INVESTIGATION AND PROCESSING ALLEGED VIOLATIONS OF THE VIRUS-SERUM-TOXIN ACT CVB-SOP-0037 (July 21, 2020)

• VBI Procedures ICWI0016 (August 3, 2017)


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


• Nonconforming Veterinary Biological Investigation (VBI) Files - Maintenance of Work Reports - ICWI0037


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


• 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)


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


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


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


• Work Flow for Initiating a Regulatory Action or Regulatory Correspondence Using the Mail Log System and Portal CVB-WI-0155 (February 19, 2020)


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

5.     PHARMACOVIGILANCE OF VETERINARY BIOLOGICAL PRODUCTS

• Receiving Adverse Event Reports at the CVB - CVB-SOP-0038
  

• Adverse Event Report Form


• Entering and Verifying Adverse Event Reports in PV-Works - CVB-WI-0123


• CVB Inspection and Compliance Procedure for Generating Case Summaries from PV Works System CVB-WI-0127 (September 05, 2019)


• Reviewing, Coding and Assessing Adverse Event Reports from the Public in PV-Works CVB-WI-0124 (August 10, 2021)
  

6.     PROCESSING SERIAL RECORDS

• VS Memo 800.53 (June 27, 2014)


• Processing Serial Records ICSOP0010 (November 9, 2016)
  

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


• Conditional Serial Release ICWI0410 (April 28, 2017)


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


• Hold Management Process for APHIS Form 2008s CVB-WI-0158 (May 20, 2021)
  

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

• QA Process for Serial Release CVB-WI-0162 (March 29, 2022)


• Log APHIS Form 2008 CVB-WI-0163 (January 2, 2020)


• Mock Checks in LSRTIS Phase II


• Review Hold Release Document - ICFRM0024


• Processing Inventory Transfers ICWI0310 (March 17, 2016)


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

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

• Rebottling/Reprocessing - Process CVB-WI-0106 (March 8, 2021)
  

• Rebottling Worksheet ICFRM0006 (January 20, 2017)
  

• Shortened Dating - Process CVB-WI-0130 (April 5, 2022)


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


• Ready for Signature Action in LSRTIS (Specialist and BCA duties) CVB-WI-0088 (August 12, 2021)


• Processing APHIS Form 2008s for Tests Completed - UNSATISFACTORY and IF the Manufacturer challenge of the CVB Laboratory Results CVB-WI-0091 (January 7, 2021)


• APHIS Dispositions and Associated Information on Form 2008s CVB-WI-0129 (August 19, 2021)


• Audits and Reference Slips for IC Documents CVB-WI-0104 (January 7, 2021)


• Items to Consider for No Tests Regarding the Wet Chick Safety Test, 9 CFR 113.207(a) CVB-WI-0133 (August 19, 2021)
  

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

• Special Test Requests Initiated by Inspection and Compliance Staff CVB-WI-0116 (February 19, 2020)
  

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

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

• Processing of APHIS Form 2008s for Prelicensing Serials, Outline Changes, or Technology Transfers CVB-WI-0108 (February 11, 2021)
  

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

• BCA Initial Review CVB-WI-0164 (April 1, 2020)


• BCA Ready for Approval CVB-WI-0165 (March 8, 2022)


• Processing CVB References and Reagents
  

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


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

7.     PRODUCT SAMPLING CVB-SOP-0040 (January 13, 2020)

• Reference Slip - Product Sample Submission


• Inspection - On Site Sampler Training and Portal Submission CVB-REF-5105 (March 8, 2021)
  

8.     PRODUCT DESTRUCTION ICSOP0005 (June 27, 2011)

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

• Preliminary Review of Facility Documents (BCA) ICWI0081 (June 25, 2018)
  

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


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

• Facility Documents: Specialist Review and Outgoing Correspondence ICWI0083 (February 7, 2018)
  

• Facility Document Correspondence ICTEM0045 (October 12, 2017)


• Facility Documents; Specialist Review, including Electronic Processing CVB-WI-0115 (October 3, 2019)
  

• Finalization of Facility Document Submission ICWI0084 (July 3, 2018)
  

• General Information
  

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


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


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


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


• Items to Consider When Processing Preliminary Drawings CVB-WI-0131 (November 25, 2019)
  

• VS Memo 800.78
  

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


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


• Instructions for Completing the Center for Veterinary Biologics Inspection and Compliance Facility Document Submission Worksheet ICWI0134 (December 26, 2017)
  

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

• Approval of Alternate Form 2008 - ICWI0002
  

11.     INSPECTION OF A FOREIGN ESTABLISHMENT (In process)

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

• Subpoena Procedures ICSOP0024 (July 26, 2018)
  

13.     SAFETY AND HEALTH

14.     INSPECTION AND COMPLIANCE POLICIES

• Compliance Policy for Issuing Regulatory Actions ICSOP0105 (April 20, 2017)
  

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

• 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)


• CVB Inspection and Compliance Policy Concerning Response to Firms and the Queue Process CVB-WI-0150 (May 20, 2021)


• Processes for Evaluating Compliance with Requirements of VS Memo 800.210 and VS Memo 800.57 CVB-WI-5218 (August 16, 2021)


• Items to Consider when Approving a Third-Party Cold Storage for Autogenous Biologics - VS Memo 800.69 CVB-WI-5291 (March 8, 2022)
  

15.     GENERAL OFFICE GUIDELINES

• Outgoing Correspondence ICSOP0011 (April 28, 2017)
  

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

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


• Receipt of Submissions from CVB-PEL CVB-WI-5209 (August 30, 2019)


• Inspection and Compliance Correspondence (LSRTIS, Mail Log Procedures) ICSOP0045 (April 13, 2018)
  

• BCA Entry and Review of Incoming Correspondence CVB-WI-0100 (March 29, 2022)


• Biologics Compliance Assistant (BCA) Finalization of Correspondence CVB-WI-0101 (November 12, 2019)


• IC Inbox Queue CVB-WI-0102 (March 23, 2021)


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


• Audits and Reference Slips for IC Documents CVB-WI-0104 (January 7, 2021)


• Mail Log Work Flow for Correspondence for Inspection and Compliance: Section Leader Review CVB-WI-0105 (March 8, 2022)


• Mail Log Work Flow for Correspondence for Inspection and Compliance: Biologics Specialist Review ICWI0236 (April 11, 2018)


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

• Inspection and Compliance Weekly Report to the President Examples CVB-WI-0125


• Redaction Process for Documents Posted to the CVB Procedure Manuals on the CVB Website CVB-WI-0078 (July 01, 2019)


• Program Coordinator Duties CVB-WI-0090 (March 29, 2022)


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

16.     REFUSAL OF ENTRY, ASSAULT AND BRIBERY PROCEDURES 

• USDA Secretary’s Memorandum 4430-2


• USDA Departmental Regulation 4200-001


• USDA Handbook on Workplace Violence Prevention and Response


• APHIS Form 259-R, Workplace Incident Report


• USDA Ethics Training
  

17.     GENERAL COMPUTER GUIDELINES 

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

18.     EXPORT ACTIVITIES

• Export Certificates and Certificates of Licensing and Inspection ICSOP0044 (July 5, 2018)


• Entry and Primary Review of Export Documents (APHIS Form 2017 and Certificates of Licensing and Inspection) ICWI0068 (July 6, 2018)


• Secondary Review of Export Documents (APHIS Form 2017 and Certificates of Licensing and Inspection) ICWI0069 (July 6, 2018)


• Finalization and Mailing of Export Documents (APHIS Form 2017 and Certificates of Licensing and Inspection) - ICWI0070


• Export Information ICWI0063 (November 01, 2016)


• Submitting Letter to the U.S. Department of State Office of Authentications CVB-WI-0094 (March 7, 2019)


• Audits and Reference Slips for IC Documents CVB-WI-0104 (January 7, 2021)
  

19.     MISCELLANEOUS 

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


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

• Workload Indicator Calculations for On-Site Inspections - ICWI0127


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


• Workload Indicator Calculations for Compliance CVB-WI-0149 (August 20, 2019)


• Monthly Workload Indicator Calculations for Pharmacovigilance CVB-WI-0153


• Workload Indicator Calculations for Imported Product CVB-WI-0156 (February 11, 2020)


• Workload Indicator Calculations for Policy Documents - ICWI0927 (April 12, 2016)


• Tracking Customer Service using LSRTIS Phone Log CVB-WI-0141 (February 19, 2019)
  

• Processing United States Veterinary Permits for Importation and Transportation of Controlled Materials and Organisms and Vectors (VS Form 16-6A MAR 95) ICSOP0032 (March 22, 2018)
  

• 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 (March 23, 2018)
  

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


• Processing CVB Reference and Reagent Test Reports ICWI3001 (November 16, 2011)


• Legal Hold Release Document ICFRM0020 (April 11, 2014)


• Nonconforming Work-AIRs - ICWI0020


• Training Plan for BCAs - ICFRM0021