For regulated industries to meet and maintain specific standards, they must follow good practices. Each industry has different good practices guidelines that define the framework of their particular quality control measures. In this article, we will take a look at what good practices are, who is in charge of enforcing them and how they fit into the food industry.
GxP: Why It Matters
The processes used to create a product have Good Practices, or GxP applied to them as guidelines. In certain industries, those good practices define quality in ways that are specific to that individual industry. As an example, good practices in the food, pharmaceutical, and medical device industries focus on products and materials that will come in direct contact with consumers. In the aviation industry, good practices center on the level of safety and performance of aircraft parts and vehicles.
There are different designations to GxP to identify on which area the guidelines are meant to focus. For example, if the guidelines are being used in areas that include laboratories, the “x” in GxP becomes an “L” to read GLP, with the “L” indicating laboratories. If the area of focus is manufacturing, the designation would be GMP, with the “M” indicating manufacturing. For areas of distribution, it becomes GDP. There are several other variations but these are the most common. A designation of cGxP indicates that the “current” good practices are in use as opposed to those of an outdated framework.
What Organizations Govern GxP for Food and Beverage Industries?
The FDA (Food and Drug Administration) administers the good practices guidelines and enforces them through a series of inspections. These inspections are used to not only verify compliance but to locate violations and to punish them accordingly.
The foundation of the system of good practices is based on a three-pillar model. The principles that make up these pillars are traceability, accountability and data integrity.
This is the documentation part of the equation. It should contain enough information to completely describe the process used to create the final product or material. This would also include details on raw material batches, environmental conditions, and equipment qualification to name a few areas.
Records showing who participated in the process, as well as documentation related to their specific qualifications and training, would be here. Full training records and data related to who used what equipment and for how long would also be recorded and kept as part of the accountability files.
The other two pillars are joined with this one designation simply because it defines the “completeness, consistency, and accuracy of data” according to the FDA. The data collected is expected to follow the ALCOA rule which is explained as attributable, legible, contemporaneously recorded, original (or true copy), and accurate.
What Are Critical GxP Areas for the Food Industry?
The good practices used in both the food and agriculture industries have gone through many changes. The evolution over the past decade can be attributed mostly to the Food Safety Modernization Act (FMSA) which was passed in 2011. Another contributing factor that has caused the food and agriculture industries to evolve is the ongoing concern related to foodborne illnesses.
The FSMA contains the main relevant regulations related to both the manufacture and distribution of food. Also, CFR (Code of Federal Regulations) 21 Part 110, 111 and 112 focus on the specific GxP.
CFR 21 Part 110 – this section centers on the manufacturing and distribution of food
CFR 21 Part 111 – this section concentrates on the guidelines for dietary supplements
CFR 21 Part 112 – this section has details related to produce
Also, the United States Department of Agriculture (USDA) has standards published for two different areas. They are Good Agricultural Practices (GAP) and Good Handling Practices (GGP). These standards are aligned with the FSMA to provide consistency.
One interesting difference between the USDA and FDA is that produce suppliers can be audited by the USDA for compliance on a volunteer basis. The results of such an audit will provide valuable information related to readiness for inspection by the FDA.
Tips To Help You Reach And Maintain Good Practices
Compliance is the goal and to reach the level of the expected standard, you can take a few actions yourself. These tips will help you with the quality control that should be in place according to the good practices for the food industry.
Tip 1 – Data Recording
By following the protocol set out by the ALCOA rule, all information about processes, production, storage, and environmental conditions can be recorded for reference.
Tip 2 – Data Storage
According to Dickson, all information collected should be stored in a way that keeps it secure and accessible. This means utilizing a form of organization to keep files orderly.
Tip 3 – Use SOPs
Standard Operating Procedures give you the guidelines for documenting all processes and procedures. This creates the data for storage and review purposes.
Tip 4 – Training Programs
All employees should have the correct training for their position. Additional training should be provided when required.
Tip 5 – Keep Reviewing
With a systematic procedure in place to continually validate equipment and processes, you will be able to maintain compliance with ease.
Tip 6 – Perform Audits
By implementing a regular cycle of internal audits aimed at the best practices for the food and agriculture industries, you can be better prepared for FDA inspections.
The food and agriculture industries are heavily regulated. To meet specific standards, there are several good practices established. They provide the framework necessary for producers and manufacturers within the food and agriculture industries to meet and maintain the standards expected within these organizations.
There are many ways to reach the best practices standards that are built upon three main pillars. They are traceability, accountability and data integrity. These three principles provide details on the procedures required to be compliant with GxP for the food industry. It may sound complicated but the standards are in place to protect all parties concerned about food safety. Implementing procedures and appropriate record keeping methods will not only help you be in compliance with good practices, it will also make it easier to do so.