Good manufacturing practices help a manufacturer better recognise, investigate and

take appropriate planned action to protect the consumer and marketplace from
exposure to any potentially harmful ingredients or practices.
Eddie Murray | Feb 16, 2022

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.

In this article:

 The 6th GMP

 Why GMPs remain essential
 How to prove GMP compliance

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.