What are GMPs?
Good Manufacturing Practices (GMPs) are the set of standards used to determine if a manufacturer is maintaining practices set by federal, state and county regulations. GMPs include industry recommendations. These easy to understand and execute standards allow companies to operate in confidence that their facility is acting in good faith to satisfy requirements from any regulatory body that may come and inspect the facility. Current U.S. Food and Drug Administration (FDA) regulations require all breweries to have an active GMP program in place.
What are GMPCBs?
GMPs cover various subjects. Good Manufacturing Practices for Craft Brewers (GMPCBs) are representative of standards needed for brewing facilities. There are more GMPs for other types of food and beverage manufacturing plants.
GMPCBs include establishing strong quality management systems, obtaining appropriate quality raw materials, establishing standard operating procedures, detecting and investigating product quality deviations, maintaining reliable laboratory tests, meeting sanitary and processing requirements, and packaging and labeling according to approved standards. GMPCBs help to prevent contamination, mix-ups, deviations, failures and errors and are the foundation for any brewery’s quality assurance program.
These standards help to audit the facility, are set in checklist form, and are organized under these topics:
- Plants and Grounds
- Equipment and Utensils
- Sanitary Facilities and Controls
- Sanitary Operations
- Processes and Controls
These standards will help keep the facility clean, safe and pest-free as well as ensure good employee hygiene.
Good Management Practices Checklists
Why Good Manufacturing Practices for Craft Brewers are Necessary
Good Manufacturing Practices for Craft Brewers (GMPCBs) are the foundation for all quality, food safety and organizational initiatives in any brewery. GMPCBs should be clearly defined and established before a brewery begins production, regardless of production volume. They require continual improvement and ongoing employee education.
GMPCBs are a critical aspect of any brewery environment for the following reasons:
- They are required for all food and beverage manufacturers of any size by the United States Food and Drug Administration (FDA) and can also be enforced by state and/or local health departments.
- They establish clear guidelines for the hygiene and cleanliness of the workers and their workplace.
- They are the foundation of any quality or food safety program in any manufacturing setting.
- They dramatically decrease the food safety risk for the brewery’s customers.
- They are easy to execute and maintain.
Failure to implement GMPCBs can result in the following outcomes:
- Penalties for noncompliance with FDA requirements to institute GMPCBs can range from the issuance of a letter notifying the brewery of a violation and requesting correction, to criminal prosecution of the individual or firm. Other FDA regulatory actions can include seizure of products, injunctions to refrain from production, and criminal fines.
- Publicity associated with an FDA enforcement action or a product recall created by a lack of GMPCBs can result in decreased public confidence and loss of income.
Implementation of Good Manufacturing Practices for Craft Brewers will instill a sense of pride and ownership in both the brewery’s work environment and its standing in the community.
Frequently Asked Questions
|What are these documents?||In keeping with the pattern of FDA form 2966, these checklists go through each item on FDA form 2966 and expand upon the checklist items, as well as provide a number of best practice recommendations to increase the value in this document intended for a craft brewer audience.|
|Why are these documents needed?||When a brewery is visited by an FDA officer for a site inspection, the officer will be using FDA form 2966 as their guide in conducting the inspection. Using the same pattern as FDA form 2966 to proactively prepare for an inspection as well as taking initiative to maintain FDA compliance will demonstrate to any interested party that the brewery is serious about compliance and aims to do so in as efficient a manner as possible.|
|How do I use these documents?||These checklists can be as useful as a brewery desires. The starting point for compliance is not this document, but rather the brewery’s intention. This document is best viewed as one of several tools that can be helpful in carrying out the intent to comply. Working through each item on the checklists will illuminate where specific improvement is needed in brewery’s operations. Each checklist covers a separate heading of FDA form 2966 and each item in the checklists is numbered to match the item numbers contained in FDA form 2966|
|What are GMPs?||GMPs is a plural abbreviation for “Good Manufacturing Practices.” In certain industries, the abbreviation is alternately expressed as cGMP or CGMPs to reference Current Good Manufacturing Practice regulations enforced by the FDA.|
|Why am I required to comply?||The FDA has the responsibility to ensure brewery compliance with GMPs and has authority to levy actions and fines for non-compliance.|
|What are these documents based on?||The checklists are based on Form FDA 2966 (3/13) and the Code of Federal Regulations (21CFR110). Download the most recent version of FDA form 2966.|
The United States (U.S.) Department of Health and Human Services, Food and Drug Administration (FDA) now has jurisdiction in breweries under the Federal Food Safety Modernization Act (FSMA). This Act was signed into law by President Obama in 2011. All breweries are now subject to FDA regulation based upon the statutory requirements of the FSMA. The foundation for this major shift in jurisdiction from the federal government regulating breweries solely under the former Bureau of Alcohol Tobacco and Firearms (and now the Tax and Trade Bureau of the Department of Treasury, or TTB) was the Bioterrorism Act of 2002. FDA and TTB now share joint authority over all breweries in the U.S. that either acquire raw materials or any process equipment from across state lines or that sell finished goods across state lines. So if you can grow all your raw materials in your home state ,and have all your tanks and kegs fabricated in your home state, then you don’t have to worry about the additional burden of regulation derived from the FSMA.
If you are interested in learning more about the role of the FDA and the FSMA as they relate to breweries, you can reference a presentation from the 2013 Craft Brewers Conference in the members-only content from the Brewers Association website under “Resources: Presentations: FDA Regulation of the Brewing Industry.” Additionally, the Master Brewers Association of the Americas (MBAA) has some helpful content on its website that is available to all viewers, not just MBAA members.
This document has been created as a resource of the Brewers Association (BA) by the Quality Subcommittee of the BA Technical Committee and is intended to serve as a guide for craft breweries in implementing good manufacturing practices and to assist with FDA compliance. This guide is merely a tool that can aid a craft brewery in this regard, but it is not intended as a guarantee of complete compliance nor is it an FDA-sanctioned document. Any additional compliance requirements that are beyond the scope of this guide are the responsibility of brewery management.