Current Good Manufacturing Practices (cGMP) ensure that supplements are safe to consume. They require that any facility that manufactures, packages, labels and holds dietary supplements must uphold specific quality standards when it comes to their methods of operation. The aim of cGMP is to guarantee that what the consumer sees on the label, matches what is inside the bottle and that the material inside the bottle has not been contaminated along the way.
The US Food and Drug Administration (FDA) implemented 21 CFR Part 111 in reference to the supplement industry and this is the baseline regulation for all manufacturers to follow; these are the minimum standards for how supplements must be manufactured, processed and packaged.
The ‘c’ in cGMP is of the utmost importance – 21 CFR Part 111 is frequently updated, so companies must stay up to date on current Good Manufacturing Practices.
What does 21 CFR Part 111 include?
21 CFR Part 111 is daunting to look at and it is difficult to summarize concisely. It breaks down into 16 subparts which relate to all aspects of manufacturing from the very beginning of the lifecycle of a product (bringing in raw materials) to the end (ensuring label claims are met).
Arguably the most important aspect of cGMP though is Quality. A quality control team must be present, and they will approve or reject all aspects of a product – from the raw materials and components, through to the label and finished product. They will ensure paperwork has been completed correctly and in accordance with internal procedures.
Having strict quality procedures in place means that:
- Specifications are in place – every single raw material and component must have a written specification listing all the item’s characteristics. It is against these specifications that all raw materials and components will be tested.
- SOPs are established – an SOP will exist for every aspect of cGMP in your workplace. These will include how to receive materials, how to label products, how to clean equipment, when and how to document information and more.
- Testing is undertaken – Testing happens when raw materials are received, when components are received and when the finished product has exited the line of production. This is why specifications are vital to have in place.
How can you be sure your manufacturer is following cGMP?
This is a difficult question to answer. Enforcement of 21 CFR Part 111 occurs via unannounced audits of the manufacturing facility by the FDA; this means that there could be very long stretches between audits which opens the possibility of manufacturers cutting costs and corners and not upholding the standards required.
One extra layer of reassurance is to look for a company that has been third-party certified, for instance by the National Sanitation Foundation (NSF). Seeing manufacturers displaying this logo means they have committed to an independent organization undertaking regular audits to ensure they are following cGMP. To learn more about NSF certification you can read NSF 455-2 explained for supplement brands.