In the November 1, 2016, Federal Register, here and here, FDA announced the availability of two guidance documents for industry titled "What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals" and "What You Need to Know About the FDA Regulation: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food"—Small Entity Compliance Guide. The small entity compliance guides are intended to help small entities comply with the final rules titled "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals," and "Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food," respectively. The guidance documents include definitions, compliance dates for their respective exceptions, and answers related to a variety of aspects concerning the current good manufacturing practices, as well as the hazard analysis and preventive controls facilities must have in place to be in compliance with the final rule.
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