As we learned in Part 1, the FDA has established Good Manufacturing Practices (GMPs) for dietary supplement manufacturers. These are also known as current Good Manufacturing Practices (cGMPs). The terms GMP and cGMP are used interchangeably, with that little “c” simply serving as an extra reminder for manufacturers to always stay up to date with the most current standards.
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?
GMP regulations are designed to ensure that the manufacturing processes of dietary supplements are safe, controlled, and of high quality. Compliance with GMPs is essential because it promotes product consistency and quality. It also reduces the risk of contamination, errors, and recalls.
GMPs cover all aspects of manufacturing, from the quality of the raw materials used to the finished product packaging. Manufacturers must have written procedures for all production operations, and the procedures must be followed precisely to ensure consistency in the manufacturing process. GMPs also require manufacturers to have ongoing training policies for all personnel.
An overview of GMP requirements is as follows, while a more detailed look can be found on the FDA website or in the Code of Federal Regulations.:
Often referred to as the five Ps, the key categories covered by GMP include:
The foundation of any organization is its people. We all know that a chain is only as strong as its weakest link, and that one bad apple spoils the bunch. That's why a GMP facility is only interested in strong links and good apples. All personnel should be well qualified for their role, with the proper education, training, and experience. Their responsibilities need to be clearly communicated and understood, and staff must be fully trained and regularly assessed. All employees are to be held accountable for following procedures, and they are responsible for maintaining their own personal hygiene as well as the sanitation of their work environment.
If cleanliness truly is next to godliness, then a GMP facility should be one of the holiest places on Earth. The premises includes not just the physical plant and grounds, but also the equipment and utensils used in production. Everything must be kept clean and sanitized at all times. All equipment also needs to be regularly calibrated and inspected for expected performance. The property should be maintained to protect against contamination of any kind, with proper storage of materials, safe water supply and plumbing, effective pest control, adequate waste disposal, and more.
Nobody wants a manufacturer to just wing it. Even if you have the best people and the cleanest premises, they can’t be effective without established processes for completing their work. All critical steps in every process need to be clearly identified and strictly followed. This results in a safe, consistent operation. Documentation is key, as it not only helps to keep track of the required processes, but it also provides a roadmap for auditors during an inspection. If any changes are made to a process, the documentation must be updated, and the changes should be communicated to all necessary staff and included in ongoing training programs.
Should you test: (a) the ingredients of a product before it is processed, (b) the intermediate components during production, or (c) the finished product after production is complete? The answer for a GMP facility, of course, is: (d) all of the above. There need to be clear product specifications for every stage of production, from raw materials to final product. Quality control is essential, which is achieved through constant testing. The goal is to create consistent products with no deviations throughout the manufacturing process. In addition to product requirements for testing, manufacturing, packaging, labeling, holding, and distributing, there are also guidelines for how to handle product returns or complaints.
This “P” could also be labeled “paperwork,” as it is all about creating documented guidelines for all critical processes. Every process requires a written Standard Operating Procedure (SOP). All employees need to be trained on the SOPs relevant to their role, and these procedures must always be kept updated. In fact, there should even be a procedure for updating procedures.
Speaking of processes and procedures, there is another important method in manufacturing called Hazard Analysis and Critical Control Points (HACCP). Find out what these control points are and why they're so critical in Part 3. Also, how can we be sure that a company is in compliance? Learn about GMP and HACCP certification in Part 4.
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