FDA CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals
标准简介
CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。标准截图
![CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals[附网盘链接]](/img/202109141037046fyfp.jpg)
标准文档说明
标准文档类型为CVM GFI #245 Hazard Analysis and Risk-Based Preventive Controls for Food for Animals[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。标准部分原文
Draft—Not for Implementation Hazard Analysis and Risk-Based Preventive Controls for Food for Animals Draft Guidance For Industry This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or we) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. INTRODUCTION In Title 21 of the Code of Federal Regulations (21 CFR) part 507 (part 507), we have established our regulation entitled “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals”. We published the final rule establishing part 507 in the Federal Register of September 17, 2015 (80 FR 56170). Part 507 establishes requirements for current good manufacturing practice for animal food (CGMPs), for hazard analysis and risk-
based preventive controls for animal food (PCAF), and related requirements as shown in Table 1. Table 1. Subparts Established in 21 CFR Part 507
SUBPART TITLE A General Provisions B Current Good Manufacturing Practice C Hazard Analysis and Risk-Based Preventive Controls D Withdrawal of a Qualified Facility Exemption E Supply-Chain Program F Requirements Applying to Records That Must be Established and Maintained Part 507, subparts A, C, D, E, and F contain the complete animal food preventive controls requirements (the PCAF requirements). This guidance document focuses on subpart C, the primary preventive controls requirements, and also discusses relevant recordkeeping requirements of subpart F. Although subpart E, the supply-chain program, is a type of preventive control, we intend to address subpart E in future guidance. The PCAF requirements implement certain provisions of the FDA Food Safety Modernization Act (FSMA) established in section 418 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 350g). Part 507 includes several complete or partial exemptions from the PCAF requirements. See 21 CFR 507.5 for these exemptions. In part 507, “you” means the owner, operator, or agent in charge of a facility (see 21 CFR 507.3). However, for the purposes of this guidance document, where appropriate, “you” also
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