VendorMatch.pro: Crafting SSOPs to Achieve Compliance with 21 CFR Part 117 - cGMP and HARPC for Human Food
In the food industry, maintaining compliance with regulatory frameworks such as 21 CFR Part 117 is essential for ensuring food safety and operational integrity. These regulations, which outline Current Good Manufacturing Practices (cGMP) and Hazard Analysis and Risk-Based Preventive Controls (HARPC) for Human Food, require detailed Standard Sanitation Operating Procedures (SSOPs). VendorMatch.pro stepped in to help a food manufacturer develop comprehensive SSOPs that align with these stringent requirements, enabling seamless compliance and operational efficiency.
The Challenge: Navigating 21 CFR Part 117 Compliance
For the food manufacturer, achieving compliance presented several challenges:
- Complex Regulatory Standards: Understanding and implementing the detailed requirements of 21 CFR Part 117, including cGMP and HARPC provisions.
- Tailored Sanitation Procedures: Developing SSOPs specific to their operations, processes, and facilities.
- Documentation and Monitoring: Creating thorough records to demonstrate compliance during inspections and audits.
- Ongoing Compliance: Ensuring procedures are adaptable to regulatory updates and evolving operational needs.
The VendorMatch.pro Solution
VendorMatch.pro, powered by interlinkIQ.com, provided expert support services to guide the food manufacturer through the development of compliant and effective SSOPs.
How It Worked:
- Needs Assessment: VendorMatch.pro conducted a detailed evaluation of the manufacturer’s operations, identifying critical areas for sanitation and compliance.
- Custom SSOP Development: Collaborating with industry experts, VendorMatch.pro created tailored SSOPs that addressed:
- Cleaning and sanitizing schedules for equipment, facilities, and utensils.
- Personnel hygiene practices and training requirements.
- Monitoring and verification procedures to ensure ongoing adherence.
- Preventive measures for minimizing cross-contamination risks.
- Compliance Integration: VendorMatch.pro ensured the SSOPs aligned with HARPC requirements by:
- Incorporating hazard analysis and risk-based preventive controls.
- Establishing corrective actions for non-compliance incidents.
- Developing recordkeeping protocols to meet FDA inspection standards.
- Ongoing Support: VendorMatch.pro provided ongoing guidance to:
- Adapt SSOPs to changing regulations and operational shifts.
- Train staff on implementing and maintaining sanitation procedures.
Results: Comprehensive Compliance and Operational Excellence
With VendorMatch.pro’s assistance, the food manufacturer achieved significant milestones:
- Regulatory Compliance: The tailored SSOPs met all requirements outlined in 21 CFR Part 117, ensuring full compliance with cGMP and HARPC.
- Improved Sanitation Practices: Detailed procedures enhanced cleanliness and safety across operations.
- Inspection Readiness: Thorough documentation and monitoring protocols prepared the manufacturer for FDA inspections and audits.
- Operational Efficiency: Standardized processes streamlined sanitation activities, saving time and resources.
Why Choose VendorMatch.pro?
VendorMatch.pro is a trusted partner for navigating complex compliance landscapes. By connecting businesses with industry experts and providing tailored support, we ensure food manufacturers can meet regulatory demands while optimizing their operations.
Whether you’re developing SSOPs, implementing HARPC controls, or preparing for audits, VendorMatch.pro has the expertise and resources to help you succeed.
Ready to simplify your compliance journey?
Discover how VendorMatch.pro can support your business in achieving seamless compliance with 21 CFR Part 117 and other regulatory requirements. Contact us today!