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Center for Veterinary Biologics |
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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
2.2 VS Memo 800.1
2.3 Delegation of Authority for Center for Veterinary Biologics - Inspection and Compliance - ICSOP0001 (April 3, 2013– 33 KB)
3. INSPECTION OF ESTABLISHMENTS - Principles (In process)
3.1 VS Memo 800.8
3.2 Pre-Inspection Activities - ICSOP0012 (April 3, 2013- 27 KB)
- Requesting Special Inspections - ICWI0012 (November 25, 2009 - 13 KB)
3.2.1 IC Pre-Inspection Packet Checklist - ICWI0041 (August 7, 2012 - 8 KB)
- Pre-Inspection Blueprint Worksheet - ICFRM0001 (July 3, 2008 - 10 KB)
- Inspection Product Check-off Sheet - ICFRM0002 (January 5, 2006 - 10 KB)
- Performing a Query to Get a List of Last Inspection Dates by Firm and Site in AIMS/LSRTIS - ICWI0008 (November 9, 2009 - 11 KB)
3.3 The Inspection Proper - ICSOP0013 (April 3, 2013 - 60 KB)3.2.2 Scheduling Inspection in LSRTIS Phase III, Specialist Role - ICWI0112 (October 26, 2011 - 8 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)
3.4 Refusal of Entry for Inspection, Assault, and Bribery Procedures - ICSOP0028 (August 25, 2009 - 283 KB)
- Refusal of Entry Related to Inspections and Investigations - ICWI0113 (December 17, 2010 – 14 KB)
3.5 Post-Inspection Activities - ICSOP0015 (April 3, 2013- 33 KB)
3.5.3 General Guidelines for Inspection Report Format - ICWI0015 (April 4, 2013 – 263 KB)
3.6 Processing Administrative Inspection Reviews - ICSOP0004 (April 4, 2013 - 39 KB)
- 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 (April 4, 2013 - 13 KB)
4.3 Nonconforming Veterinary Biological Investigation (VBI) Files - Maintenance of Work Reports - ICWI0037 (April 4, 2013 - 7 KB)
4.4 Tests Requested to Assist Investigations – Processes and Responsibilities - CVBSOP0101
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)
5. PHARMACOVIGILANCE OF VETERINARY BIOLOGICAL PRODUCTS
5.1 Receiving Adverse Event Reports at the CVB - ICSOP0017 (April 3, 2013 - 26 KB)
5.1.1 Adverse Event Report Brochure (41KB - January 2008)
5.1.2 Adverse Event Report Form (16KB)
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 Guidelines for Coding Adverse Event Reports - (Inactivated)
5.3 Guidelines for the Evaluation of Adverse Event Reports - (Inactivated)
5.4 Guidelines for the Pharmacovigilance Monitoring Committee - (Inactivated)
5.5 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 (November 7, 2006 - 35 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)
6.2.2 Reviewing Incoming Form 2008s and Related Serial Release Documents - ICWI0007 (February 1, 2010 - 16 KB)
6.2.3 BCA Work Instructions for Processing Form 2008s that are “Unsat Based on Firm’s Testing” - ICWI0009 (April 6, 2011 - 38 KB)
6.2.4 Processing Inventory Transfers - ICWI0310 (September 14, 2009 - 94 KB)
6.2.5 Early and/or Conditional Serial Release - ICWI0410 (August 27, 2010 - 20 KB)
6.2.6 APHIS Form 2008 Pen and Ink Guidance - ICWI0610 (March 18, 2011- 8 KB)
6.2.7 Unit of Measure Use and Conversion for Data Entry into LSRTIS - ICWI0710 (March 18, 2011 - 11 KB)
6.2.8 Hold Management Process for APHIS Form 2008s - ICWI0810 (May 8, 2012 - 22 KB)
6.2.9 Mail Receipt, Process, and Distribution - ICWI0910 (April 4, 2013 - 38 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 Special Test Request Procedures - ICSOP0021 (February 14, 2007 - 187 KB)
- 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)
- Extension of Dating Worksheet (9 CFR 114.14) - ICFRM0107 (December 23, 2008 - 11 KB)
- 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 (August 8, 2007 - 23 KB)
6.8 Rabies Vaccine Process Deviations - ICWI0005 (April 4, 2013 - 8 KB)
7. PRODUCT SAMPLING - ICSOP0022 (June 27, 2011- 109 KB)
8. PRODUCT DESTRUCTION - ICSOP0005 (June 27, 2011- 115 KB)
9. PROCESSING FACILITY DOCUMENTS - ICSOP0018 (February 12, 2010 - 115 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 (July 25, 2011 - 16 KB)
9.3 General Guidelines on Designating a Building or Area Separate and Apart - ICWI0004 (November 9, 2009 - 8 KB)
9.4 Formulating a Blueprint Letter in Response to Facility Document Submissions - ICWI0018 (December 14, 2009 - 90 KB)
9.5 Listing Fractions in Facility Documents - ICWI0029 (April 4, 2013 - 9 KB)
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
13. SAFETY AND HEALTH
14. INSPECTION AND COMPLIANCE POLICIES
14.1 Compliance Policy for Issuing Regulatory Actions - ICWI0105 (October 23, 2012, 23 KB)
15. GENERAL OFFICE GUIDELINES
15.1 Scanning Project for Special Outlines - ICSOP0020
15.2 Accessing FedEx to Send Regulatory Letters – ICWI0019
15.3 Outgoing Correspondence - ICSOP0011
15.3.1 Outgoing Correspondence - ICWI0011
15.3.2 Mail Verification Process in the BCA Area - ICWI0111
Processing Freedom of Information Act (FOIA) Requests - ICWI0036
15.4 General Inspection and Compliance Correspondence Guidance - ICSOP0042 - 25 KB (June 20, 2012)
15.5 Filing Procedure Guidelines for Inspection and Compliance - ICSOP0037
15.6 File Room Work Instructions
15.7 IC Documents to Archives - ICFRM1005
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
17.3 Using the Audited 2008 Database (In process)
17.4 Outline Exceptions Database (In process)
17.5 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
18.2 Export Certificates in LSRTIS Phase III - ICWI0039, (20 KB, December 20, 2011)
18.3 Creating Certificates of Licensing and Inspection in LSRTIS Phase III - ICWI0038, (25KB, December 20, 2011)
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
19.2.2 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
19.3 Processing United States Veterinary Permits for Importation and Transportation of Controlled Materials and Organisms and Vectors (VS Form 16-6A MAR 95) - ICSOP0032
- 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
19.6 APHIS Mandated Stop Distribution and Sale Procedures - ICWI0033, 17 KB (April 6, 2011)
20. TEMPLATES
ICTEM0001 CVB Letter
ICTEM0002 Autogenous Non-Adjacent Letter
ICTEM0003 Blueprint Letter
ICTEM0004 CVB Certified Letter
ICTEM0005 Letter of Advice
ICTEM0006 Delegation for Signing VS Forms 2017, 2046, and 2047
ICTEM0007 Hold Release - Reference
ICTEM0008 Infraction Notice
ICTEM0009 Inspection - Report
ICTEM0010 Inspection - Cover Letter
ICTEM0011 Inspection - Notice to Inspect
ICTEM0012 Final Prelicensing Memo
ICTEM0014 Isolate Extension
ICTEM0015 Personnel Changes - Letter to Firm
ICTEM0016 Process Deviation
ICTEM0017 Reference Slip - Blank
ICTEM0018 Reference Slip - Return Cert of Lic & Insp
ICTEM0019 Reference Slips - Airbills
ICTEM0020 Regulatory - Autogenous Recall
ICTEM0022 Regulatory - Voluntary Stop Sale
ICTEM0023 Sampler Authorization Letter
ICTEM0024 Warning
ICTEM0025 Mock 2008
ICTEM0026 AER Request for Information
ICTEM0027 Select Agent Memo
ICTEM0028 First Prelicensing Memo
ICTEM0029 AIR Acknowledgement Letter
ICTEM0030 AIR Opening - Licensees
ICTEM0031 AIR Opening - Permittees
ICTEM0034 Nonresponses to AIRs
ICTEM0035 Field Investigation Report
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