Whether you’re producing a simple soft gel or an advanced superfood powder, dietary supplement manufacturing requires precise inventory management. Live inventory systems can ensure you have enough stock and maximize waste. The present study utilized cross-sectional data collected from 90 CMOs that manufacture dietary supplements. It was found that the adoption rate of GMP was correlated with the number of product categories a CMO can manufacture.
GMP Requirements
GMP regulations are detailed, stringent rules that all manufacturers must follow during production. These regulations ensure that a supplement has the proper ingredient identity, strength, purity, and safety that matches its label. They also include processes for making the product down to the smallest detail, testing at various stages of production, and extensive documentation that allows producers to trace problems back to their source. National governments enforce GMP requirements through various means, including inspections and recalls.
For the dietary supplement manufacturing industry, the FDA enforces these regulations through Current Good Manufacturing Practices (cGMP), which are similar to the requirements for pharmaceutical drugs. This study explores the relationship between the key characteristics of a CMO and its adoption rate of GMP for dietary supplements. It also explores how the industry could use its knowledge of cGMP regulations to innovate and improve supplement manufacturing processes. This information is essential to help manufacturers avoid pitfalls that can cause costly problems like contamination, mix-ups, and failures.
Raw Materials
All dietary supplement products begin with raw materials. These are ingredients that can be derived from either plant or animal sources and also include minerals that have been mined from the earth. The FDA requires manufacturers to use only high-quality, contaminant-free raw materials for their products. They must also keep meticulous records of each step in the production process, train and qualify their manufacturing personnel, and test all final products for compliance with label claims. Dietary Supplement GMP regulations, outlined in 21 CFR 111, are comprehensive and apply to all aspects of a dietary supplements manufacturer’s operations. Understanding the requirements is challenging for many DS companies, and inconsistencies with the regulations have resulted in numerous FDA observations and Warning Letters.
Manufacturing Processes
For dietary supplement companies, transparency in ingredients and efficacy are crucial to building trust with consumers. Whether through ingredient sourcing or backing up formulas with science, this sets a good company apart. To make a supplement, you need the right equipment and quality ingredients. These factors determine how long it takes to complete the manufacturing process. Finding a contract manufacturer who understands your specific product and can provide the best manufacturing process is essential. Manufacturers must follow strict cGMP regulations to ensure the supplements are ready for shipping. This includes testing incoming raw materials to ensure they meet specifications before inventorying them. It’s also necessary to track the production of each batch and assign expiry dates. This helps manufacturers stay in compliance and prevents potential recalls. The FDA’s final regulation on cGMPs for dietary supplements set stringent standards that require manufacturers to verify their products’ identity, purity, strength, and composition.
Packaging
The manufacturing of supplements is a highly complex process and requires strict adherence to regulatory requirements and rigorous quality control procedures. The industry is expected to continue to see rapid innovation and growth due to ongoing scientific discovery and consumer demand for personalized nutrition. A physical plant refers to the facility where a manufacturer conducts its manufacturing, packaging, labeling, or holding operations for dietary supplement products. It includes all buildings and rooms used for these operations and all equipment, utilities, and services connected to them. Current good manufacturing practices (cGMPs) are the US Food and Drug Administration’s extensive requirements to prevent contamination, mix-ups, deviations, and failures during production and to ensure dietary supplements’ identity, strength, quality, and composition. cGMP regulations establish uniform standards that companies must follow for all product batches.
