GMP: As Good As It Gets (Part 3)

While Part 2 discussed the key factors of maintaining a GMP facility, Part 3 will now focus on how manufacturers can even go above and beyond those standards by implementing a HACCP program. The goal of HACCP is to keep all potential hazards in the manufacturing process under control.

RECAP! This is part of our four-part series that addresses the following questions: Part 1: What is the role of the FDA? Part 2: What makes a GMP facility? Part 3: What are the principles of HACCP? Part 4: What is SGS certification?

Keeping Hazards Under Control

As the old saying goes, an ounce of prevention is worth a pound of cure.

It is much better to avoid a hazard in the first place than be forced to deal with its consequences after the fact. Would you rather practice defensive driving or get into a collision? Brush your teeth or get a cavity? Put up your hurricane shutters or watch the storm break your windows?

Life is certainly filled with hazards all around us, and manufacturing facilities are no exception. Therefore, a responsible manufacturer takes all the necessary precautions to ensure the utmost safety and control over all aspects of the operation.

HACCP Takes Off

This is where Hazard Analysis and Critical Control Points (HACCP) come in.  HACCP was first developed in the 1960s during a collaboration between NASA, the U.S. Army Laboratories, and the Pillsbury Company. Pillsbury had been tasked with manufacturing the first foods for space flight, and obviously this food had to meet the highest standards for safety possible. Inspired by NASA’s own strict engineering requirements, Critical Control Points (CCP), the partners applied similar principles to food processing, identifying and eliminating any “critical failure areas” in their procedures. This approach allowed them to successfully produce food safe for space expeditions.

Later development of this method ultimately led to HACCP becoming an internationally recognized standard for food safety to be applied during the manufacturing of food, ingredients, and beverages. HACCP is mandatory for certain types of food processers, such as meat, poultry, juice, and seafood. While it is a voluntary program for dietary supplement manufacturers, MT Brands has chosen to adopt HACCP in our facilities in order to go above and beyond all safety requirements.

HACCP Principles

HACCP incorporates seven principles which focus on identifying and preventing hazards that could lead to contamination or adverse events from dietary supplement products:

1. Conduct a hazard analysis: The purpose of the hazard analysis is to identify potential physical, chemical, and biological hazards associated with the manufacturing, packaging, and labeling process.

2. Identify critical control points (CCPs): A CCP is a point in the manufacturing process where a control measure can be applied to prevent or eliminate a hazard. For example, a CCP for a dietary supplement might be a step where the product is heated to a specific temperature to eliminate a biological hazard.

3. Establish critical limits: Critical limits are parameters that must be met to ensure the effectiveness of a control measure. For example, a critical limit for a heating process might be the minimum temperature required to eliminate a specific biological hazard.

4. Implement monitoring procedures: Monitoring procedures are used to ensure that CCPs are operating within the established critical limits. For example, monitoring procedures for a heating process might include temperature measurements taken at specific times during the heating process.

5. Establish corrective actions: Corrective actions are taken when monitoring procedures indicate that a CCP is not operating within the established critical limits. For example, if temperature measurements indicate that the heating process is not reaching the required temperature, corrective actions might include adjusting the heating equipment or reprocessing the product.

6. Establish verification procedures: Verification procedures are used to ensure the effectiveness of the HACCP plan. For example, verification procedures might include periodic testing of finished products to confirm that they meet established specifications.

7. Establish record-keeping and documentation procedures: Record-keeping and documentation procedures are used to ensure that the HACCP plan is being implemented effectively. For example, records might include temperature measurements taken during the heating process or test results from finished products.

It is important for manufacturers of dietary supplements to have a thorough understanding of HACCP principles and to implement a HACCP plan that is tailored to their specific manufacturing process.

Coming Up Next

Now that we know what makes GMP and HACCP facilities so superior, how can we be sure that they are actually in compliance? Find out in Part 4 how certification from an independent third-party organization like SGS can help manufacturers prove their worth.