How to Prepare a Food and Safety Plan as per the FDA in 7 Steps.

How to Prepare a Food and Safety Plan as per the FDA in 7 steps

 

In this article, you will learn how to prepare a food and safety plan as per cGMP Good Manufacturing Practices

The requirements of the food and safety plan are described in the 21 CFR Part 117. CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD.

7 Steps to Write a Food & Safety Plan:

The food safety plan must be prepared, or its preparation is overseen, by one or more quality assurance representatives:

The written food safety plan must include:

(1) The written hazard analysis as required by 117.130(a)(2);

(2) The written preventive controls as required by 117.135(b);

(3) The written supply-chain program as required by subpart G of 21 CFR Part 117;

(4) The written recall plan as required by 117.139(a); and

(5) The written procedures for monitoring the implementation of the preventive controls as required by 117.145(a);

(6) The written corrective action procedures as required by 117.150(a)(1); and

(7) The written verification procedures as required by 117.165(b).

The food safety plan is a record that is subject to the requirements of subpart F of the 21 CFR Part 117.

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CIQA is a quality and regulatory consultant with 25 years of experience developing products and managing projects in the medical device supply chain, and pharmaceutical industries. His experience includes research, product development, operations management, manufacturing engineering, equipment design, regulatory affairs, and quality assurance. Specific questions about Document Control Management DCM or quality system training can be directed to CIQA at ramon.cayuela@ciqa.net.

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REFERENCES: How to Prepare a Food and Safety Plan

STATUTORY AND REGULATORY REQUIREMENTS

PART 117 — CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=117

Subpart C–Hazard Analysis and Risk-Based Preventive Controls

Sec. 117.126 Food safety plan.

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=117.126

Rules and Standards for Food Processing

httpss://www.ag.ndsu.edu/foodlaw/processingsector/rules-and-standards-for-food-processing

TITLE 21–FOOD AND DRUGS

CHAPTER I–FOOD AND DRUG ADMINISTRATION

SUBCHAPTER B–FOOD FOR HUMAN CONSUMPTION

PART 110 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

httpss://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=110

For more information about How to Prepare a Food and Safety Plan, refer to:

httpss://tcisys.com/sqfcodetemplates.php

httpss://www.afsc.org/sites/default/files/documents/FINALCOLOR%20AFSC%20Food%20Safety%20Manual.pdf

httpss://safetyculture.com/checklists/food-safety/

Ramon Cayuela, MS, BS, Chemical Engineering

Ramon Cayuela, MS, BS, Chemical Engineering

CIQA President and CEO.
I've been working in validation engineering since 1992 with many multinational pharmaceutical companies. I love sharing my passion and knowledge with others. If you have any questions about anything (or just have general questions). I will be more than happy to assist you. You can count on the BEST customer service on CIQA. I go to great lengths to make sure my clients are 100% satisfied with their purchases and check emails/messages consistently throughout the day. You can rest assured that everything being sold here is as-described or your money back. I look forward to working with you!