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Validation and Verification: A Practical, Industry-driven Framework Developed to Support the Requirements of the Food Safety Modernization Act (FSMA) of 2011
A general interest paper outlining the Preventive Controls Summit 2013 and their guidance on developing effective strategies for meeting validation and verification requirements. The most relevant information begins on p. 413.
A framework for developing and implementing a risk management plan with associated activities to ensure appropriate safety measures
Describing a Hazard That Needs Control in Documents Accompanying the Food, as Required by Four Rules Implementing the FDA Food Safety Modernization Act: Guidance for Industry
A guide to hazard description, including which rules require it and how to describe hazards
A guide to some of the essential components of developing a food safety plan, including flow diagrams, hazards, preliminary steps, prerequisite programs, and principles of food safety plans.
A series of short write ups explaining necessary components of food safety programs. These programs and policies can be part of a prerequisite program, good manufacturing practices, preventive controls, or critical control points. Topics covered include allergens, approved suppliers, calibration, cleaning and sanitizing, consumer complaints, control of foreign material, crisis management, environmental monitoring, food defense, internal audits, non-conforming products, hold and release programs, pest control, preventive maintenance, product release, product specifications, quality control, recall program, receiving program, training program, verification program, and water supply.
A description of the FSMA Final rule for Preventive Controls for Human food, key requirements, assistance for industry, meetings and webinars, related guidance, supporting material, and contact information
A collection of forms recommended by the FDA in developing a Food Safety Plan with additional useful guidance
Small Entity Compliance Guide: What You Need to Know About Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
A guide designed to provide small entity processors with the most essential aspects of FSMA's Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule.
Understanding the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
A document explaining some of the new regulations introduced in 21 CFR 117 (Current Good Manufacturing Practice, Hazard Analysis, and Risk Based Preventive Controls for Human Food), useful definitions, summaries of the different subparts, and includes examples of which subparts may apply to different foods.
A blog post explaining the differences between HACCP and HARPC. It explains the role of HACCP in being FSMA compliant and the major components of a HARPC plan that producers must follow.