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).
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 firstname.lastname@example.org.
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Three (3) Options to Create Document Control Management DCM Procedures:
Bronze Option. You Can Create Your Own Quality Procedures, using a Template.
You can download samples of the Document Control Management DCM procedure templates in .pdf format.
To see the complete list of the most popular quality procedures templates, click here.
In addition, you can request a quotation to buy online a full SOP template document in MS Word format that is completely editable, ready to fill, and adapt to your specific needs.
Silver Option. We Can Bring You Formal Training about How to Prepare a Food and Safety Plan.
This option is recommended if you want to learn more about how to build robust quality system procedures. One of our expert(s) can provide online step-by-step training to your team (unlimited assistance) on how to build reliable SOPs using our template(s). Also, you can improve your corporate quality procedures and policies by incorporating our template(s) and tools. It includes a fully editable template from the Bronze option, plus training, exams, and a training certificate for each assistant. Request a quote now.
Gold Option. We Can Create Customized Quality Procedures.
One of our expert(s) will create and prepare your customized SOPs with the inputs and specific information of your company. It includes a fully editable template from the Bronze option, plus online support in document creation, implementation, and training. Request a quote online.
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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
Subpart C–Hazard Analysis and Risk-Based Preventive Controls
Sec. 117.126 Food safety plan.
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
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