Animal Feed Regulatory Program Standards (AFRPS) Maintenance and the Enhancement of Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food Regulatory (PCAF) Activities

动物饲料监管计划标准 (AFRPS) 维持和加强现行良好生产规范 (cGMP) 以及动物食品监管 (PCAF) 活动的预防控制

• 批准号: 10254364
• 负责人: JONATHAN L ROBERTS
• 金额: $ 27.98万
• 依托单位: LOUISIANA DEPT OF AGRICULTURE/FORESTRY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-09-01 至 2025-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10254364
• 关键词: Animal; Feed; Regulatory; Program; Standards

Project Summary/Abstract Animal Feed Regulatory Program Standards (AFRPS) Maintenance and the Enhancement of Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food (PCAF) Regulatory Activities FOA: PAR-20-13 Development and Maintenance of the Animal Feed Regulatory Program Standards with Optional Coordinated Preventive Control Regulatory Activities and Capacity Building (U18) Clinical Trial Not Allowed The Louisiana Department of Agriculture & Forestry’s (LDAF), Office of Animal Health & Food Safety (AHFS), Feed Program Division is currently finalizing year 5 of the Animal Feed Regulatory Program Standards (AFRPS) Development and Implementation Grant (RFA-FD-15-021) and expects to be found in full conformance during the program’s final FDA audit scheduled for August 2020. The LDAF AHFS Feed Program plans to move forward with the maintenance phase of the FDA AFRPS Program and enroll in the Preventive Controls (PC) Funding Opportunity to support the FDA Preventive Controls Initiative. The Feed Program plans to maintain FDA Contract work for feed related activities while annually increasing the capability and capacity to conduct all comprehensive inspections covered under 21 CFR Part 507. The LDAF AHFS Feed Program will support the LDAF Agricultural Chemistry Laboratory by providing trained personnel for sample collection allowing the Laboratory to enhance its scope and capacity. The Feed Program plans to identify and train a qualified field inspection trainer for comprehensive inspections which include Current Good Manufacturing Practices (cGMP) and Preventive Controls for Animal Food (PCAF). The program will enhance its outreach program by identifying outreach venues and developing outreach materials that pertain to PCAF regulation. The Feed Program plans to move forward with the State Auditor Program by moving towards Phase 2 and 3. The program plans to participate in and help develop capabilities to share regulatory data with the FDA through IT interface platforms such as the National Food Safety Data Exchange (NFSDX). The program will continue to work with the FDA to evaluate an enhance data collection and enforcement strategies, especially as it pertains to cGMP and PCAF compliance. The Feed Program will continue to support the FDA by providing current firm inventories categorized by risk. Finally, The LDAF AHFS Feed Program with develop a sound Exit Strategy by year 5 that will outline how the program will sustain required resources for program enhancement and implementation, advancements in cGMP/PC regulatory work activities and maintain full conformance with the AFRPS. Maintaining full conformance with the AFRPS will assist both Louisiana and the Food and Drug Administration (FDA) to better direct their regulatory activities toward preventing feed manufacturing compliance issues and increasing food safety and Public Health within the United States.

项目总结/摘要 动物饲料监管计划标准（AFRPS）维护 和加强现行良好生产规范 （cGMP）和动物食品预防控制（PCAF）法规 活动 FOA：PAR-20-13动物饲料监管计划的制定和维护 具有可选协调预防控制监管活动和能力的标准 建筑（U18）不允许进行临床试验 路易斯安那州农业和林业部（LDAF），动物健康和食品安全办公室 （AHFS），饲料计划司目前正在完成动物饲料监管计划的第5年 标准（AFRPS）开发和实施补助金（RFA-FD-15-021），并预计将被发现 在计划于2020年8月进行的最终FDA审计期间完全符合要求。LDAF AHFS 饲料计划计划推进FDA AFRPS计划的维护阶段， 参加预防控制（PC）资助机会，以支持FDA预防控制 倡议饲料项目计划维持FDA与饲料相关活动的合同工作， 每年提高能力和能力，以进行 21 CFR第507部分。LDAF AHFS饲料计划将支持LDAF农业化学 实验室提供训练有素的人员进行样本采集，使实验室能够加强其 范围和能力。饲料计划计划确定并培训合格的现场检查培训员 全面检查，包括现行药品生产质量管理规范（cGMP）和 动物食品预防控制（PCAF）该方案将通过以下方式加强其外联方案： 确定外联地点，并编制与太平洋武装部队条例有关的外联材料。的 饲料计划计划通过进入第二阶段和第三阶段来推进国家审计员计划。 该项目计划参与并帮助开发与FDA共享监管数据的能力 通过信息技术接口平台，如国家食品安全数据交换（NFSDX）。的 该计划将继续与FDA合作，评估加强数据收集和执行的情况 战略，特别是涉及cGMP和PCAF合规性。饲料计划将继续 通过提供按风险分类的当前公司库存来支持FDA。最后，LDAF AHFS 饲料计划与制定一个健全的退出战略，在第5年，将概述如何该计划将 持续提供所需资源，以加强和实施方案，促进cGMP/PC 监管工作活动，并保持完全符合AFRPS。保持充分 遵守AFRPS将有助于路易斯安那州和食品药品管理局（FDA） 更好地指导他们的监管活动，以防止饲料生产合规问题， 提高美国的食品安全和公共卫生。