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1949stone

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[资源] cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food

cGMP, Hazard Analysis, and Risk-Based Preventive Controls for Human Food


The Food and Drug
Administration (FDA or we) is
amending our regulation for Current
Good Manufacturing Practice In
Manufacturing, Packing, or Holding
Human Food in two fundamental ways.
First, we are modernizing the long-
standing current good manufacturing
practice requirements. Second, we are
adding requirements for domestic and
foreign facilities that are subject to our
regulation for Registration of Food
Facilities to establish and implement
hazard analysis and risk-based
preventive controls for human food. We
also are revising certain definitions in
our regulation for Registration of Food
Facilities to clarify the scope of the
exemption from registration
requirements provided for ‘‘farms’’ and,
in so doing, to clarify which domestic
and foreign facilities are subject to the
requirements for hazard analysis and
risk-based preventive controls for
human food. We are taking this action
as part of our announced initiative to
revisit the current good manufacturing
practice requirements since they were
last revised in 1986 and to implement
new statutory provisions in the FDA
Food Safety Modernization Act. The
rule is intended to build a food safety
system for the future that makes
modern, science- and risk-based
preventive controls the norm across all
sectors of the food system.
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yuanchang5楼
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