Applying GMPs to Animal Food Production Facilities 20 April 2017
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Office of Surveillance and Compliance Center for Veterinary Medicine Welcome Dianne Milazzo Office of Surveillance and Compliance Center for Veterinary Medicine
Agenda Background on Preventive Controls Animal Food (PCAF) rule FY17 CGMP Animal Food (AF) Assignment CGMP AF Inspection Experiences FY18 and beyond
Background Who is covered under PCAF rule (21 CFR part 507)? In general, facilities that manufacture, process, pack, or hold animal food for consumption in the U.S. and are required to register with FDA under section 415 of the FD&C Act (food facility registration) Applies to domestic and imported animal food There are some exemptions (§507.5) and requirements for qualified facilities (§507.7)
PCAF COMPLIANCE DATES
FY17 CGMP AF ASSIGNMENT Trained investigators from Oct 2016 or Feb 2017 courses Upcoming training courses August 2017 Two in 1st quarter FY18 Conducting 250 inspections No other CVM programs Technical Assistance Five states = 32 inspections
CGMP AF Inspections Renderers Feed Mills Pet Food
FY18 AND BEYOND FY18 Other Business and small business sized establishments = CGMP requirements Other Business size establishments = Preventive Controls (PC) requirements Number of inspections = TBD
FY18 AND BEYOND, Cont. FY19 All business sizes = CGMP requirements Other Business and small business sized establishments = PC requirements
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FSMA Rule Readiness Training Resources FDA Employees: http://inside.fda.gov:9003/CFSAN/CFSANStaffCollege/FoodSafetyModernazationAct/ucm449582.htm State Employees: https://www.foodshield.org/blog-training-news/
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THANK YOU FOR ATTENDING FSMA RULE READINESS TRAINING Applying GMPs to Animal Food Production Facilities