In the world of dietary supplements, quality is a crucial aspect. More is needed for a product to look good on the shelf; it must be safe for use and meet a wide range of regulatory requirements.
It requires thorough quality control at every stage of the manufacturing process — from ingredient sourcing to finished product testing. It is one of the most complex and challenging areas of supplement manufacturing, but it’s also crucial for safety and brand image.
Process control constantly adjusts and monitors processes to ensure products are produced within certain quality limits. This practice is essential in industries such as pulp and paper, manufacturing, and oil and gas.
Supplement manufacturer use process controls to ensure that all medications manufactured at their plants are safe and effective. It is mainly because the raw materials used for these products can vary widely in quality, so constant adjustments are needed to keep them consistent throughout the manufacturing process.
In the case of dietary supplements, all raw ingredients, finished product containers, closures, packaging, and labeling used to manufacture a dietary supplement should be inspected to confirm their identity, strength, quality, and purity. Similarly, the finished product should be tested to verify that it is free of metals and other contaminants.
In-process testing is vital because it enables a manufacturer to monitor the quality of the raw materials that comprise a dietary supplement. It includes checking the levels of certain ingredients to ensure that the mix is as uniform as possible.
For instance, weight uniformity is a critical control point during capsule or tablet production. Each tablet or capsule must be within a specific weight range to ensure an even distribution of the nutrient ingredients.
These specifications are critical for batch control because they provide a way to identify deviations in the raw materials that could significantly impact the final product. In addition, they help the manufacturer determine if additional in-process controls are necessary to verify that the products being made are as they should be.
In-process tests may replace finished-product CQAs when the data generated by these tests are sufficient to justify it. This approach should be validated to ensure that the test results or product performance characteristics do not change from the in-process stage to the finished product.
Finished Product Testing
Finished product testing is the final step in manufacturing and ensures that all stages of production are done under reasonable process control. It includes providing the correct mixing, encapsulation, and coating processes to produce a quality supplement.
It can also help determine whether a food is contaminated during the manufacturing process or was produced in an unsanitary manner. It is essential in dietary supplements, where several plant species with similar names could infect the product.
Generally, however, finished product sampling provides only limited information on food safety. It is especially true for food products prone to reduction, recontamination, and growth.
Regulatory compliance is a vital part of the production of dietary supplements. It requires that all processes, equipment, and personnel are in place to ensure that products meet regulatory standards.
The FDA’s current good manufacturing practices rule regulates dietary supplements’ manufacturing, labeling, and storage. It also requires that ingredients and other substances are correctly tested and used to ensure they are safe, effective, and high-quality.
Dietary supplements must meet the identity, purity, strength, and composition specifications and not be contaminated by harmful or undesirable substances. Following these guidelines and staying current on all relevant legislation and regulations is critical.
In addition, dietary supplement manufacturers must follow corrective and preventive action procedures (CAPAs). CAPAs are a best practice function in many manufacturing verticals and should be a core part of the production process for all companies.