Demystifying USDA licensure and its importance to diagnostic testing
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1 Demystifying USDA licensure and its importance to diagnostic testing April 15 th, The world leader in serving science
2 Regulatory Overview APHIS regulates veterinary biologics (vaccines, bacterins, antisera, diagnostic kits, and other products of biological origin) to ensure that the veterinary biologics available for the diagnosis, prevention, and treatment of animal diseases are pure, safe, potent, and effective. This work is done by APHIS' Center for Veterinary Biologics (CVB) and is centered around enforcement of the Virus Serum Toxin Act 2
3 Regulatory Scope Sample Preparation Instrumentation & Software Test Kits NOT REGULATED NOT REGULATED REGULATED 3
4 Regulatory Overview Three focus areas for USDA approval for Veterinary diagnostics Production Facility Test Kit Performance Test Kit Production and Commercialization VS Memorandum : General Requirements for Immunodiagnostic Test Kits for the Detection of Antibody or Antigen 4
5 Facility Requirements Plot Plans, Blueprints, and Legends Fraction List/Risk Assessment Personnel Qualifications Serial Release Adverse Event Reporting Facility Inspections 5
6 Performance Requirements Field Sensitivity and Specificity, Field Repeatability and Reproducibility, Analytical Studies (i.e., Limit of Detection, Inclusivity, Exclusivity, etc.), and Stability 6
7 Production and Commercialization Outline of Production Intended Use, Limitations Raw materials produced in house or sourced from qualified suppliers Standardized/Validated manufacturing processes Serial Release criteria Test Kit Configuration Product Labeling 7
8 USDA Facility and Product Licenses USDA Veterinary Biologics Establishment License USDA Veterinary Biologics Product License 8
9 In Summary USDA Licensed/Permitted Products are: Manufactured in an inspected, approved facility in a controlled environment by qualified operators, Manufactured with qualified raw materials using validated processes, monitored for consistent serial-to-serial performance, Validated in the laboratory and in the field and found to be suitable for the intended purpose, Reviewed by CVB prior to serial release, Reviewed by CVB for approval of material/process changes, and Subject to post market surveillance. 9
10 Laboratory Landscape Laboratory accreditation and validation criteria are evolving Additional documentation is needed to meet accreditation requirements USDA approved diagnostic products can help fulfill accreditation and quality standards requirements Thermo Fisher is partnering with laboratories to utilize our USDA licensed tests in standardized workflows 10 10
11 AAVLD Laboratory Accreditation Needs Before guidelines were considered, test development and validation was not standardized New AAVLD Laboratory Technology Committee Guidelines outline standardization requirements; how this is achieved is left to the laboratory directors USDA licensed test kits simplifies the effort to comply with accreditation requirements 11
12 Accreditation Guideline Compliance Current Menu of rrt-pcr Should the Lab Offer a New Test? Justification/ Scope Application /Feasibility Optimization Test Performance measures Range of Linearity LOD, Precision (R/R) Diagnostic S/S Ongoing Assessment of Assay Function / Re-validation Implementation a laborious process How can we help our customers? 12 Requires Longitudinal Management 12
13 Potential Implications: Current Service Test Performance Measures Research Laboratory Technology Committee Guidelines Near Future Service Test Performance Measures Research Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
14 Value of USDA Licensed Tests Service Test Performance Measures Research USDA Licensed Tests Service Test Performance Measures Research 14
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