Current Good Manufacturing Practice (cGMP) for Dietary Supplements

Good Manufacturing Practices, otherwise known as GMPs or Current Good Manufacturing Practices (cGMPs) are a set of regulations that outline the standards for manufacturing, processing, packing, labeling, and holding dietary supplements. The cGMPs are designed to ensure the quality, safety, and purity of dietary supplements.

There are many reasons why a dietary supplement manufacturer should have a cGMP audit. Here are a few of the most important reasons:

• SAFETY AND QUALITY : cGMP audits help ensure that dietary supplements are produced in a safe and controlled environment, using high-quality ingredients and processes. This helps protect consumers from harmful products and ensures that they are getting the products they expect.
• REGULATORY REQUIREMENTS: In 2007 the FDA published a final rule that established a regulation (21 CFR part 111) entitled Current Good Manufacturing Practice In Manufacturing, Packaging, Labeling, Or Holding Operations For Dietary Supplements (72 FR 34752). "The DS CGMP rule requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record," according to the FDA's website. Many countries have their own cGMP regulations that dietary supplement manufacturers must follow.
• REPUTATION: Consumers are increasingly demanding that dietary supplements be produced in a safe and ethical manner. Having a cGMP audit can help to demonstrate to consumers that a manufacturer is committed to producing high-quality, safe products.
• SALES: Many retailers and distributors require that dietary supplement manufacturers have a cGMP audit before they will carry their products. Having a cGMP audit can help a manufacturer to increase their sales by making their products more available to consumers.

By having an audit, manufacturers can help to ensure the safety and quality of their products, comply with regulatory requirements, improve their reputation, and increase their sales. But these reasons why brands seek out this audit in the first place are often outshined by the overarching benefits, including...

1. Increased customer confidence

A cGMP audit can help to increase customer confidence in a dietary supplement manufacturer. When customers know that a manufacturer has been audited and found to be in compliance with cGMP regulations, they are more likely to trust the manufacturer and its products.

2. Reduced risk of recalls

A cGMP audit can help to reduce the risk of recalls. When a manufacturer is in compliance with cGMP regulations, it is less likely to produce products that are contaminated or unsafe. This can help to protect the manufacturer from the financial and reputational damage that can result from a recall.

3. Improved efficiency

A cGMP audit can help to improve the efficiency of a dietary supplement manufacturer. By identifying and correcting areas where the manufacturer is not in compliance with cGMP regulations, the manufacturer can improve its processes and procedures. This can lead to reduced costs and increased productivity.

Overall, there are many benefits to having a cGMP audit for dietary supplement manufacturers. By having an audit, manufacturers can help to improve their products, protect their customers, and reduce their risks.

Click here to read more about the steps involved in this type of audit, along with the various cGMP audits that ASI offers, including those tailored for supplements, food packaging, food processing, cannabis, pet food, and more!