Choosing the proper supplement manufacturer is critical for your supplement business. To help, we have put together eight critical criteria to look for when evaluating manufacturers. Third-party testing and certification is the best way to demonstrate that dietary supplements meet regulatory standards and verify label claims.

Audits

For safe and effective Supplements must be manufactured in facilities that meet high-quality standards. A vital aspect of these standards is adherence to regulatory compliance, achieved through rigorous audits by third-party organizations. These audits cover supplement manufacturing, labeling, storage, distribution, and testing. Suppliers of Supplement ingredients are subject to a different set of regulations than those who manufacture the final supplements, and it is essential that they also adhere to strict GMP guidelines. To ensure this, they will often obtain a GMP certificate by signing up with one of the various third-party auditing and verification organizations. These organizations will conduct on-site facility audits twice yearly to verify the manufacturer’s adherence to the FDA’s 21 CFR Part 111 GMP requirements.

Certifications

Finding one with the proper certifications is essential when choosing a supplement manufacturer. These certifications help ensure that the supplements are safe and of high quality. In addition, they help to protect consumers from contaminated products. Supplement ingredient suppliers also need to have the proper certifications. These certificates demonstrate that they have met strict public health standards. These include Hazard Analysis and Critical Control Points (HACCP), a preventative food safety system that helps reduce the risk of contamination from raw materials. Another critical certificate is Informed Manufacturer, which is a manufacturing certification for facilities that manufacture and supply sports nutrition products, dietary supplements, and raw materials. This program was developed to minimize the risk of banned substance contamination in these facilities. It is also internationally recognized, which can increase market reach.

Good Manufacturing Practices (GMPs)

GMPs are standards that ensure product quality by preventing cross-contamination, mix-ups, errors, and failures during the manufacturing process. They’re also crucial to safeguarding consumers against potentially dangerous and unsafe products. GMP regulations – also known as Current Good Manufacturing Practices (cGMP) – cover the U.S. Food and Drug Administration’s formal requirements for manufacturers of over-the-counter pharmaceuticals, medical devices, and dietary supplements. CGMPs are the laws that govern how manufacturers must operate their facilities, purchase raw materials, implement standard operating procedures, and more. cGMPs are required for all pharmaceutical, medical device, and dietary supplement companies that distribute within the United States and many companies abroad. To become certified to manufacture cGMP supplements, manufacturers must pass a comprehensive inspection and audit of their facility and submit detailed records of their processes. They must also adhere to strict hygiene and safety practices, ensuring that all supplements are free from contaminants.

Experience

The supplement industry is booming, and many manufacturers want your business. However, not all manufacturers are created equal, and choosing the wrong one could spell disaster for your brand. Look for manufacturers that have GMP and UL certifications. These reputable organizations conduct inspections and testing to ensure manufacturers follow good manufacturing practices.

Additionally, they should have a variety of ingredients in-house that can be used for your custom formulation. This allows them to keep production dashing and prevents them from waiting on the order of an ingredient they may need. Another essential factor to consider is whether the manufacturer offers other in-house services. These can include packaging, shipping, and storage. Having these services in-house can help save you money and time, which is essential when creating a new supplement. In addition, a great manufacturer can assist you in creating product specifications that comply with regulatory requirements.