If you are a food manufacturer and are searching for a Food Safety Manual that satisfies the CFR 21 Part 117: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food, look no further.  Our Food Safety GMP Manual is designed for small to medium size businesses and includes 25 procedures and 50 forms, which you customize specifically for your needs.  This manual also complies with international food sfety requirements for any organization in the food chain.  

Implementation of our documented, food safety management system will enable you to meet CFR 21 Part 117 and ISO 22000 requirements at a reasonable price.  You will receive sensible procedures which, when implemented, will reduce paperwork to a minimum and will enable you to significantly improve the safety of your products and the quality of your products/services.      

Food Safety and GMP Training

An Introduction to the U.S. Food System Course from John Hopkins University

Stanford Introduction to Food and Health from Stanford University

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Good Manufacturing Practice (GMPs) are mandatory practices that should be applied to the manufacture and testing of pharmaceutical products or drugs, vivo and in vitro diagnostic products, medical devices, and foods.  GMPs are not instructions on how to manufacture products, but rather are series of general principles that must be observed during manufacturing and testing in order to yield quality and safe products.  In the United States, GMPs were developed by the Food and Drug Administration (FDA).   

The federal government uses the term "cGMP" (current good manufacturing practice)" which indicates that the current GMP is kept up to date.  "GMP" and "cGMP" is used interchangeably and has the same meaning.  

What is the Food Safety Modernization Act (FSMA)?  

"The FDA Food Safety Modernization Act (FSMA) was signed into law on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus of federal regulators from responding to contamination to preventing it."

Foreign food manufacturers exporting to the U.S. will have to comply with U.S. regulations.  This means their manufacturing plants will have to be operated in compliance with the requirements of the FDA's GMPs.

What are the benefits of compliance?

In addition to satisfying regulatory requirements, GMP compliance will yield the following benefits to your organization:

·        A systematic approach to identification of food safety hazards, which in turn aids in the development and implementation of proactive control measures.

·        Improved efficiency and profitability

·        Documented system provides useful reference

·        Improved records in case of litigation

·        Responsibilities of personnel clearly defined

·        Improved control during periods of change or growth

·        Improved communication on food safety issues

·        Improved performance from suppliers 

·        Increased customer satisfaction

The FDA’s Final Rule - Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food (HARPC) depend on activities performed by a “Preventive Controls Qualified Individual.”  

“A preventive controls qualified individual is someone who has successfully completed certain training in the development and application of risk-based preventive controls or is otherwise qualified through job experience to develop and apply a food safety system.  The written food safety plan required of food facilities must be prepared, or its preparation overseen, by one or more preventive controls qualified individuals. And the preventive controls qualified individual is charged with overseeing the validation that preventive controls are capable of controlling identified hazards and the records review.”  You may view the final rule here.

The final rule requires that every food facility subject to the rule must have one or more persons, either employees or outside experts, with the technical knowledge of the food being produced and processes developed and implemented to evaluate and control risks.

We recommend that you assess your capabilities and if you have determined that additional training is required, you may choose from the training options we offer above.  If you have determined that you will need training in the full body of knowledge (see below) according to the FSPCA curriculum, then we recommend that you seek out a FSPCA compliant course at a location closest to your facility.  

The true measure of a preventive controls qualified individual will be not his or her level of training, but the effective implementation of a Food Safety Plan that complies with the FDA’s Final Rule.

Food Safety Preventive Controls Alliance (FSPCA)

“The Food Safety Preventive Controls Alliance (FSPCA) was established in 2011 as part of a grant from the U.S. Food and Drug Administration (FDA) to the Illinois Institute of Technology’s Institute of Food Safety and Health.  The purpose of this broad-based alliance is to develop and maintain a cost effective education and training program to assist the food industry, particularly small food companies, with understanding and achieving compliance with the FDA’s Hazard Analysis and Risk-based Preventive Controls for Human Foods rule requirements.  The requirements of this regulation are designed to promote safe food production.”

“The FSPCA training materials are designed to meet the requirements for training the “qualified individual” who conducts certain Food Safety Plan activities.  The FSPCA course will be the standardized curriculum recognized by FDA and against which other training courses will be evaluated. Attending an FSPCA course is not mandatory, but it does provide assurances that the course content and resulting knowledge is consistent with regulatory expectations.”

“An outline of the FSPCA curriculum for Hazard Analysis and Preventive Controls for Human Food follows:

Chapter 1: Introduction to Course
Chapter 2: Food Safety Plan Overview
Chapter 3: Good Manufacturing Practices and Other Prerequisite Programs
Chapter 4: Food Safety Hazards
Chapter 5: Preliminary Steps in Developing a Food Safety Plan
Chapter 6: Hazard Analysis and Preventive Controls Determination
Chapter 7: Process Preventive Controls
Chapter 8: Food Allergen Preventive Controls
Chapter 9: Sanitation Preventive Controls
Chapter 10: Supplier Program
Chapter 11: Recall Plan
Chapter 12: Verification and Validation Procedures
Chapter 13: Record-keeping Procedures
Chapter 14: Regulation Overview – cGMP and Hazard Analysis and Risk-Based Preventive Controls for Human Food
Chapter 15: Resources for Food Safety Plans
Chapter 16: Preventive Controls for Human Foods Review.