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Good Manufacturing Practices (GMPs)

When I am teaching the Preventive Controls for Human Food workshop, I am often asked about Good Manufacturing Practices (GMPs). Do we still have to follow GMPs? Yes! GMPs are the foundation of a food safety system. Without GMPs or by not following GMPs, food safety cannot be achieved.

Basics done well have not changed!

A successful GMPs program requires buy in from management and commitment. In the food industry, we have seen the mindset of management change from the Quality department being a cost center to the Quality department being a necessary business expense. Quality departments have grown in personnel and budgets.

A successful GMPs program includes prerequisite programs. Some of these programs support the work you do at your facility and some of them overlap with GMPs. Prerequisite programs are procedures for the handling of ingredients and packaging from receiving to finished product at shipping, and everything in between, all with the goal of food safety. For example, your company may have a procedure for hiring and training new personnel. Prerequisite programs work hand-in-hand with GMPs and are a part of every successful company.

Let’s review where to find GMPs. GMPs have been around for ages in the food law in Part 111. Now, you will find GMPs in the FSMA rule, Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food. GMPs are a section in the Human Food rule, 21 CFR 117. In Title 21 of the Code of Federal Regulations (CFR), you will find all the rules enforced by the Food and Drug Administration; this rule is Part 117. In Part 117, there are seven sections called subparts:

Subpart A – General Provisions
Subpart B – Current Good Manufacturing Practice
Subpart C – Hazard Analysis and Risk-based Preventive Controls
Subpart D – Modified Requirements
Subpart E – Withdrawal of a Qualified Facility Exemption
Subpart F – Requirements Applying to Records That Must be Established and Maintained
Subpart G – Supply-chain Program

The FDA has dedicated one of seven subparts in the Human Food rule to GMPs; Subpart B is a big deal. Notice how GMPs are before Subpart C, which requires a facility to conduct a hazard analysis. The result of the hazard analysis is to identify hazards and then create preventive controls for each hazard. Even if a facility identifies no hazard or maybe one hazard requiring a preventive control, it doesn’t change the fact that you still need GMPs.

Even if you do not find a hazard, you still need GMPs.

The challenge in the food industry is to meet the GMPs requirement. Every facility is unique and will approach GMPs in diverse ways. The crucial step is to address GMPs to create a food manufacturing environment that results in safe food. Here is an outline of Subpart B (remember 117 means 21 CFR Part 117):

§117.10 Personnel
§117.20 Plant and grounds
§117.35 Sanitary operations
§117.37 Sanitary facilities and controls
§117.40 Equipment and utensils
§117.80 Processes and controls
§117.93 Warehousing and distribution
§117.95 Holding and distribution of human food by-products for use as animal food
§117.110 Defect action levels

Each facility must create programs to address the GMPs. Programs include training of personnel in food safety, sanitation procedures, and a pest control program. For optimal application, each program should have a written standard operating procedure (SOP) and means for record keeping. This includes sanitation SOPs or SSOPs. We say, “if it is not documented, it didn’t happen.” Inspectors and auditors will ask to see your documentation of GMPs.

The search for GMPs forms and checklists can be overwhelming. The ConnectFood website has the resources you need. After you sign in for free, you will find information under cGMPs. Do you have questions about GMPs? The folks at ConnectFood are here to help! Contact us.

Dr. Kathy Knutson has food safety expertise in microbiology, hazard analysis, and risk assessment. As a recovering academic, she resides in Green Bay home-of-the-Packers, Wisconsin with her brilliant husband and two handsome sons. Learn more about her consulting services at https://www.linkedin.com/in/kathyknutsonphd.

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What is the Food Safety Modernization Act?

In June 2016 I started teaching a workshop with FDA-recognized curriculum. Everyone was there to get a certificate as a Preventive Controls Qualified Individual (PCQI). After a day of training, someone asked, “What is FSMA?” Much to my own surprise I could not succinctly articulate the extent of FSMA nor did the curriculum do a great job of summarizing FSMA. After much research on the FDA and Federal Register websites, I have this summary for you.

FSMA is the federal Food Safety Modernization Act, signed by President Obama in January of 2011. The purpose is to ensure the U.S. food supply is safe by shifting the focus from responding to hazards to preventing them (https://www.fda.gov/Food/GuidanceRegulation/FSMA/). I now understand there are seven foundation rules with FSMA, all under the jurisdiction of the FDA. All seven rules were published from September 2015 to May 2016 with unique compliance dates. Most of you reading this are going to want information on the rule for the manufacture of human food. The preventive controls for human food final rule requires a written food safety plan, record-keeping, a recall plan, and oversight by a PCQI. A future blog will detail the role of a PCQI.

Final rule: Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
Who? Human food manufacturers and their ingredient suppliers

When? Initial compliance date of September 2016 for large businesses

FDA actually calls large businesses “other businesses.” That is because the large businesses by definition are not small, very small, qualified facilities, or subject to the Pasteurized Milk Ordinance. All of these have compliance dates beyond September 2016.

Small businesses have a compliance date of September 2017 and are defined as having fewer than 500 employees. Therefore, “other businesses” have more than 500 employees. Very small businesses have a compliance date of September 2018 and are defined as having less than $1,000,000 in annual sales and holdings. By default, very small businesses have fewer than 500 employees. With only $1,000,000 in revenue, that makes sense that the business employs fewer than 500.

Very small businesses are qualified facilities. Having a designation as a qualified facility exempts the facility from the hazard analysis, preventive controls and supply chain requirements. This is a big deal. The business is still required to follow Good Manufacturing Practices, provide attestations in support of their status, provide evidence of oversight and compliance in their location, maintain records, and provide evidence of status annually. Even though a qualified facility is not required to conduct a hazard analysis and identify preventive controls for those hazards, the qualified facility is required to state how they are controlling hazards in their process. In other words, what is the qualified facility doing to make their product safe for the consumer? If a very small business believes they are a qualified facility, their status records must already now be in place.

Businesses subject to the Pasteurized Milk Ordinance (PMO) have a compliance date of September 2018. These grade A milk processors come into compliance after the next revision of the PMO is published. The PMO will include elements of preventive control requirements.

What are the foundation rules of FSMA? Here is a summary of them:

Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
This is the animal food rule.
Who? Animal food manufacturers and their ingredient suppliers
When? Initial compliance date of September 2016
In the same way that food for human consumption must be made in a safe manner, the diverting of human food to animal food and the production of animal food must be done safely.

Foreign Supplier Verification Programs for Importers of Food for Humans and Animals
This is the import rule.
Who? Importers of ingredients or food for humans or animals
When? Initial compliance date of May 30, 2017
To see descriptions of who has later dates, go to this FDA document at https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm517545.htm.

Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
This is the produce rule.
Who? Raw agricultural commodity farmers
When? Produce growers with more than $500,000 in annual sales must be compliant starting in November 2017. Small businesses with annual sales between $250,000 and $500,000 must be compliant November 2018. Very small businesses with annual sales between $25,000 and $250,000 must be compliant November 2019. Due to high risk, sprout growers must be compliant in November 2016, with small and very small sprout growers compliant in November 2017 and 2018, respectively.
Growers may have modified compliance dates for parts of the rule including water quality standards, testing and recordkeeping; labeling; or retention of records supporting eligibility for a qualified exemption. Many commodities are exempt from parts of the rule due to the nature of the crop.

Accreditation of Third-Party Certification Bodies To Conduct Food Safety Audits and To Issue Certifications
This is the audit rule.
Who? Third-party auditors
When? The rule was published November 2015. The Model Accreditation Standards when published will include FDA’s final recommendations on third-party auditor/certification body qualifications and incorporate requirements. Thereafter, auditors will be able to apply for FDA recognition. See the draft guidance for the Model Accreditation Standards at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm455328.htm.

Sanitary Transportation of Human and Animal Food
This is the transportation rule.
Who? Motor carriers, shippers, and receivers of human or animal food
When? Initial compliance date of April 2017
Motor carriers employing fewer than 500 persons and having less than $27.5 million in annual receipts must be compliant in April 2018.

Mitigation Strategies to Protect Food Against Intentional Adulteration
This is the intentional adulteration rule.
Who? Human food manufacturers
When? This being the last of the rules was published in May 2016. The first compliance date is May 2019. Small businesses employing fewer than 500 employees must be compliant in May 2020.
The definition of the very small business is annual sales and holdings less than $10,000,000 and not $1,000,000 as defined in the preventive controls for human foods rule. The very small business must be compliant in May 2021.