Quality culture and training in the dietary supplement industry.

The U.S.-China Health Products Association .The dietary supplement industry is facing increasing scrutiny and supervision from regulators and many media. In recent days, the U.S. Food and Drug Administration has legally disposed of several dietary supplement manufacturers and their products in violation of the provisions of 21 CFR 111, and a federal court has sentenced them to substantial fines and contempt of court, an incident that has made the safety of dietary supplements-related products a hot news in the United States. But the event also enhances the advantages of outstanding enterprises in the market, while for the major dietary supplement manufacturers to serve as a warning role. Dietary supplement manufacturers need systematic training to ensure the integrity and compliance of their quality management systems.is always right to investin quality compliance with current GMPs is critical to the safety of packaging production, product quality and ensuring corporate brand reputation. However, it is difficult to consistently meet the requirements set by GMPs, as the 21 CFR 111 regulations are revised annually and the U.S. Food and Drug Administration regularly issues new guidance documents. At the same time, dietary supplement manufacturers may change their production processes due to their own changes.addition, it is difficult for companies to combine regulations with practice and reality. In response, NSF certification organizations have conducted hundreds of GMP audits for customers and found some serious oversights in the quality management system. For example: (1) a worker without gloves puts his hands in raw dough with edible dietary supplements and then puts raw dough in a squeezer dough;these examples reflect that a sound quality assurance system will involve every step of the production process. For food companies, whether or not strict quality management to implement all aspects of the company, is the industry's cutting-edge quality, but the quality of investment will always be correct.it is difficult to accurately calculate the investment and return on product quality, training to ensure product quality is essential for dietary supplement companies. In fact, 21 CFR 111 requires staff who produce dietary supplements to receive GMP training on a timely basis, and the cost of the training must be much lower than the cost of consent decrees, warning letters, 483s (defect reports), FDA fines, lawsuits, and product recalls that occur after product quality issues, and most importantly, to avoid damage to brand reputation or the reputation of corporate contract manufacturers.Fortunately, the NSF Dietary Supplements Training Program has sufficient resources available to help dietary supplement manufacturers develop comprehensive quality management systems and technical leaders to ensure consumer food safety and avoid significant illegal and economic exposure.training is the first step in quality assurance NSF certification organizations offer training courses in different places each year to facilitate learning by dietary supplement manufacturers. Courses are typically held at large industrial fairs and dietary supplement industry forums, with core courses covering every aspect of GMP compliance, including a 21 CFR 111 overview, how to prepare for FDA verification, and plant testing for identification.in order to ensure that dietary supplements enterprises comply with the provisions of The 21 CFR 111 Act in their production activities, dietary supplement industry workers must conduct qualified GMP training on a regular basis. U.S. regulations require every company, whether it's a U.S. business or a company exported to another country, or imported from another country to the U.S., to have at least one qualified employee to provide GMP training and industry guidance to other employees..The NSF Training Trainer course includes the detailed morphological, strength, composition and purity requirements for dietary supplements in Section 21 CFR 111, as well as different regulations for different types of products (vitamins, herb mixtures, probiotics, etc.). The course outlines the responsibilities of the quality, production, procurement and other departments.In addition, some courses provide targeted information to companies and warehouses that require the ability to determine compliance with Section 21 CFR 111 and follow a legal vendor approval process, as well as a system for identifying customer returns and recalls. At the same time, the course covers annual rule updates, guidelines, and recent trends in the issuance of FDA warning letters..FDA Verification ReadinessFDA dynamically verifies the production, packaging, labeling, storage, and distribution of products, and most of the results of FDA verification are warning letters. There are four main reasons companies are checked: first, product inspections of recalls, second, reports from competitors or customers to the FDA, third, FDA detailed investigation of the manufacture or use of a special raw material, and fourth, random spot checks.in order to ensure that the results of GMP verification can have a positive and positive impact on the enterprise, the enterprise needs to carry out a rigorous quality management plan and work preparation prior to the start of the verification, as well as coordination during the verification period and a comprehensive follow-up investigation after the verification. Companies can accomplish their tasks more smoothly if they understand the focus of GMP verification and the expectations of the inspectors. The NSF course provides the necessary content to help companies successfully conduct a verification, including a program for dietary supplement companies that will make every employee aware of the role to be played in this verification.plant detection: identification, identification, identification!key to plant testing for dietary supplements is identification. Companies must be able to accurately identify all plant materials used in raw materials or finished products.current GMP regulations require genetic/experimental testing of plants, which does not mean the custody of documents or sensory testing. This process is simple and straightforward for a single ingredient, such as ginger, but complex for hard-to-identify substances such as herbal essences, plant extracts, and excifectors..The NSF program provides hands-on experience with testing instruments. The quality of the enterprise and laboratory staff, even those in the purchasing department, can learn which testing instruments are critical to testing. Employees will learn how to use the instrument and the meaning of professional language.
.