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
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
批准号:
10654645
负责人:
JONATHAN L ROBERTS
金额:
$37.43万
依托单位国家:
美国
项目类别:
财政年份:
2020
资助国家:
美国
项目状态:
未结题
起止时间:
2020-09-01 至 2025-06-30
中文摘要
项目摘要/摘要
动物饲料控制性程序标准(AFRPS)维护
以及对当前良好制造规范的改进
动物性食品(CGMP)和预防性控制(PCAF)监管
活动
FOA:PAR-20-13动物饲料管理程序的制定和维护
具有可选的协调预防控制监管活动和能力的标准
不允许构建(U18)临床试验
路易斯安那州农林部(LDAF)动物健康和食品安全办公室
(AHFS),饲料计划部目前正在敲定动物饲料监管计划的第五年
标准(AFRP)开发和实施补助金(RFA-FD-15-021),预计将找到
在计划于2020年8月进行的FDA最终审计中完全符合要求。LDAF AHFS
FEED计划计划推进FDA AFRPS计划的维护阶段,并
登记预防控制(PC)资助机会,以支持FDA预防控制
主动权。饲料计划计划维护FDA与饲料相关活动的合同工作,同时
每年提高进行下列各项全面检查的能力和能力
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
范围和容量。FEED方案计划确定和培训一名合格的现场检查培训员
用于全面检查,包括当前的良好制造规范(CGMP)和
动物性食品预防性控制(PCAF)。该方案将通过以下方式加强其外展方案
确定外联场所并编写与太平洋地区合作伙伴关系条例有关的外联材料。这个
Feed计划计划通过进入第二阶段和第三阶段来推进国家审计师计划。
该计划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)。这个
该计划将继续与FDA合作,评估增强数据收集和执法
战略,特别是与遵守cGMP和PCAF有关的战略。Feed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
5年前制定合理的退出战略,概述该计划将如何
为计划的加强和实施、cGMP/PC的改进提供所需的资源
监管工作活动,并保持与AFRPS的完全一致。保持满载
遵守AFRPS将有助于路易斯安那州和食品和药物管理局(FDA)。
更好地指导他们的监管活动,以防止饲料生产合规问题和
提高美国国内的食品安全和公共卫生水平。
英文摘要
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.
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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
-
批准号:10254364
-
项目类别:
-
资助金额:$27.98万
-
财政年份:2020
-
负责人:JONATHAN L ROBERTS
-
依托单位:
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
-
批准号:10174231
-
项目类别:
-
资助金额:$45.0万
-
财政年份:2020
-
负责人:JONATHAN L ROBERTS
-
依托单位:
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
-
批准号:10457365
-
项目类别:
-
资助金额:$20.48万
-
财政年份:2020
-
负责人:JONATHAN L ROBERTS
-
依托单位:
LDAF Feed Program Implementation of the Animal Feed Regulatory Program Standards (AFRPS)
-
批准号:9334616
-
项目类别:
-
资助金额:$60.0万
-
财政年份:2015
-
负责人:JONATHAN L ROBERTS
-
依托单位:
LDAF Feed Program Implementation of the Animal Feed Regulatory Program Standards (AFRPS)
-
批准号:9769501
-
项目类别:
-
资助金额:$19.15万
-
财政年份:2015
-
负责人:JONATHAN L ROBERTS
-
依托单位:
海外基金