{"product_id":"u-s-preventive-controls-for-human-food-management-system-21-cfr-117","title":"U.S. Preventive Controls for Human Food Management System (21 CFR 117)","description":"\u003cp\u003e\u003cem\u003eAn editable 21 CFR Part 117 documentation system for any U.S. food facility, built around a written food safety plan and not tied to one sector.\u003c\/em\u003e\u003c\/p\u003e\n\u003ch2\u003eOverview\u003c\/h2\u003e\n\u003cp\u003eA U.S. food facility under 21 CFR Part 117 has to show its hazard analysis, the preventive controls it chose, how it monitors and verifies them, and how it would recall a product. This system builds that record around a food safety plan template with an owner signature section, and a cross-reference matrix that maps each Part 117 section to the package documents, forms and records.\u003c\/p\u003e\n\u003cp\u003eIt starts with the regulatory framework and an FSMA applicability assessment, then the manual, policy, food safety team and PCQI statement. Prerequisite programmes cover CGMP, hygiene, sanitation, allergens, suppliers, receiving, storage, pest control, chemicals, glass, foreign material, maintenance, calibration, water, waste and traceability. The food safety plan core covers process, sanitation, allergen and supply-chain preventive controls, with monitoring, corrective action, verification, validation, reanalysis and recordkeeping.\u003c\/p\u003e\n\u003cp\u003eThe files map 21 CFR Part 117 section by section and treat 21 CFR Part 1 Subparts H, J, L, O and S and Part 121 as related requirements, with 21 CFR 101, 111, 113, 120 and 123 as boundaries. FDA draft guidance is used as nonbinding reference. AGS is independent and is not affiliated with the FDA. Regulations are referenced by citation, and no regulation text is included.\u003c\/p\u003e\n\u003ch2\u003eWhat this system covers\u003c\/h2\u003e\n\u003cul\u003e\n\u003cli\u003e\n\u003cstrong\u003eFramework:\u003c\/strong\u003e regulatory framework, FSMA applicability assessment, food safety and preventive controls manual, policy, food safety team and PCQI statement.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003ePrerequisite programmes:\u003c\/strong\u003e CGMP, hygiene, sanitation, allergens, suppliers, pest control, foreign material, maintenance, calibration, water and traceability.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eFood safety plan:\u003c\/strong\u003e a plan template, hazard analysis, and process, sanitation, allergen and supply-chain preventive controls.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eSupply chain and recall:\u003c\/strong\u003e a supply-chain programme and a written recall plan with a contact and notification structure.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eVerification:\u003c\/strong\u003e monitoring, corrective action, verification, validation, reanalysis and recordkeeping.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eWider protection:\u003c\/strong\u003e food defence, food fraud, emergency management, internal audit and management review.\u003c\/li\u003e\n\u003cli\u003e\n\u003cstrong\u003eTools:\u003c\/strong\u003e forms, checklists, training modules, Excel workbooks for the master register, hazard analysis, cross-reference and gap assessment, a hazard library, an inspection readiness guide, an implementation guide, a 30-day roadmap and a reference library.\u003c\/li\u003e\n\u003c\/ul\u003e\n\u003ch2\u003eWho it's for\u003c\/h2\u003e\n\u003cp\u003eU.S. food manufacturers, processors, packers, warehouses, co-packers and private-label makers, and start-ups preparing a first food safety plan. It suits small and medium facilities in any sector, and an existing facility can start with the gap assessment workbook.\u003c\/p\u003e\n\u003cp\u003eEach sector system in this range carries its own preventive controls manual, for example the U.S. Bakery HACCP \u0026amp; Preventive Controls Management System (21 CFR 117) and the U.S. Ready-to-Eat Foods Preventive Controls Management System (21 CFR 117). For Codex HACCP, see the FSMS CodexHACCP-2023.\u003c\/p\u003e","brand":"Apex Global Solutions AGS","offers":[{"title":"Default Title","offer_id":57395117982036,"sku":"AGS-16-044","price":990.0,"currency_code":"USD","in_stock":true}],"thumbnail_url":"\/\/cdn.shopify.com\/s\/files\/1\/1052\/4996\/4372\/files\/AGS-16-044.png?v=1790973682","url":"https:\/\/agskits.com\/products\/u-s-preventive-controls-for-human-food-management-system-21-cfr-117","provider":"Apex Global Solutions","version":"1.0","type":"link"}