21 CFR PART 117
21 CFR Part 117 is known as The FDA Food Safety Modernization Act (FSMA) Produce Safety replacing 21 CFR Part 110 governing food and beverage products. FSMA is now final and enforcement of compliance is to begin in the September 2016. The rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption.
REJIMUS provides support for the preparation of operational compliance with FSMA requirements, including writing HACCP plan, HACCP Reviews, HARPC plans in addition to resolving matters stemming from non-compliance following a regulatory inspection. An absolutely critical understanding of this new regulation, is that because not only are Foods governed, but Dietary Supplements as a class of Foods, are governed under this new regulation as well, there are and will be compliance requirements resulting from FSMA that can be enforced across all ingredient and manufacturers. Are you prepared?
• HACCP/HARPC Plan Writing & Revising/Optimization
• HARPC Plan Writing and Food GMP Compliance Audits
• SOP Development and Implementation (onsite or remote training)
• Foreign Supplier Verification Program (FSVP) design and implementation
• Quality System Optimization
• Recall Management, Recall Procedures Reviews and Mock Recalls