Good manufacturing practices (GMPs) help to ensure the consistent quality and safety of products by focusing attention on five key elements, which are often referred to as the 5 P’s of GMP—people, premises, processes, products and procedures (or paperwork). These are nothing new, but an increasing number of retailers are requiring supplement brands to show proof of GMP compliance and independent ingredient testing before they will allow products to be sold on their shelves.
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The 6th GMP
Most supplement manufacturers have been aware of the need to follow GMPs for years. After all, it’s been written into the U.S. Code of Federal Regulations (21 CFR 111) for decades. But we’ve seen an increasing emphasis on proof of GMP compliance in the last few years. Indeed, it’s fair to say the five Ps of GMPs have been expanded to include a sixth P: proof.
With consumers demanding greater transparency and retailers facing legal exposure and regulatory warnings, many major retailers and online platforms are now requiring dietary supplement brands to provide proof of compliance with GMPs. For example, Amazon updated its dietary supplement seller requirements in April 2021 and no doubt continues to review those requirements after receiving an FDA warning letter in July 2021. CVS Health launched its Tested to be Trusted™ program in 2019. Both programs require brands and manufacturers to provide independent, third-party certification of GMP compliance as well as other quality and testing requirements. Already, we are seeing other retailers follow suit.
Why GMPs remain essential
GMPs help ensure consistent, acceptable product quality and safety. An effective GMP reduces risk, helps companies save money, upholds a company’s reputation and helps to create a competitive edge in an increasingly crowded marketplace. The benefits of GMP compliance are just as relevant to the dietary supplement industry as they are to the pharmaceutical industry.
One of the most critical components of GMP is quality control (QC)—the process of sampling, testing and comparing results with pre-agreed specifications as part of the overall quality assurance (QA) process. For supplement manufacturers, a well-designed QC system does not focus simply on finished product testing, but rather also utilizes the most appropriate analytical techniques to assure the quality of materials throughout the process.
How to prove GMP compliance
Independent certification of compliance may be new territory for many brands. Fortunately, there are a few ways to document a manufacturing facility’s GMP compliance.
Brands and manufacturers must establish a process for periodic review of compliance with the requirements detailed in 21 CFR 111, the dietary supplement GMPs. Ideally, this review should occur at least annually. While independent, third-party review of GMP compliance is not required by the U.S. FDA, many major retailers are now requiring third-party assurance of GMP compliance. A regularly occurring, external review of your quality control system by an experienced and trusted partner is the best way to maintain compliance and avoid mishaps that can impact the quality and safety of your product. Frequent quality management system training is also required. If you decide to invest in an independent third-party audit of your GMP compliance, be sure to choose a partner that is accredited by ANAB to provide NSF/ANSI 455-2 dietary supplement GMP certification. We expect retailers to increasingly demand certification by an accredited certification body.
Another way to prove GMP compliance involves membership in the Global Retailer and Manufacturer Alliance (GRMA). Major retailers and manufacturers have joined together as the GRMA to create and manage harmonized quality requirements in several non-food related industries, including dietary supplements. The GRMA is a member-based organization with broad industry support from key global retailers within the grocery, drug, mass merchandiser and club store channels. Members include retailers, manufacturers, trade associations, certification bodies and other stakeholders.
When you join the GRMA, you agree to meet the requirements of the GRMA’s GMP audit program – which is based on a consensus standard known as NSF/ANSI 455-2 - Good Manufacturing Practices for Dietary Supplements. As a GRMA member, you can benefit from the ability to share the results of your GMP audits with other members of the group, which includes a growing list of retailers. This level of transparency is designed to help participating retailers find brands and manufacturing facilities that meet the GRMA requirements. Audits are performed by your choice of three approved certification bodies: NSF International, UL or Perry Johnson Registrars. Upon completion of the audit, your audit reports are published on the GRMA web portal and can be visible to other GRMA members. If you pass the audit, you’ll receive GRMA certification and NSF/ANSI 455-2 certification from the certifier. You’ll also have permission to use the GRMA logo on your website.
We are encouraged to see retailers and brands working together to establish retail requirements to protect consumers and differentiate quality products in the marketplace. GMPs are the heart of these quality programs. Understanding GMPs and how to prove compliance has never been more important, which makes this an ideal time to refresh your understanding of GMPs with online training from NSF.
Eddie Murray is the senior manager at NSF Health Sciences Certification.
