The goal of the GRMA is to enhance industry harmonization. We do this by providing key industry players the “same set of rules.” This “rulebook” is our certification program.
Our certification program is currently focused on three health and wellness product categories:
- Dietary supplements [i.e., any product with a Supplements Facts Panel (SFP) on its packaging]
- Over-the-counter drugs [i.e., any product with a Drug Facts Panel on its packaging]
- Cosmetics/personal care/health & beauty aids [i.e., any product that meets the regulatory definition of “Cosmetic” under the Food, Drug & Cosmetic (FD&C) Act, Sec. 201(i)]
Each of these categories has unique regulations and best practices.
What regulations are covered in the GRMA certification program?
At the heart of the GRMA certification program are the core industry requirements. These regulations and GMPs (Good Manufacturing Practices) set a strong foundation for protecting public health and safety. They’re long-standing and are both nationally and globally recognized.
When it came time to develop our certification program, we discovered an opportunity to build upon that foundation. We used the rigorous ANAB/ANSI standards process, to uncover additional expectations, within each of our categories.
The GRMA certification program covers both the core industry requirements and additional GMP best practices.
What are the GMP requirements for the GRMA’s focal product categories?
Each product category has distinct core industry requirements set by the FDA, or in the case of cosmetics, ISO22716 and the FDA Cosmetic GMP Guidance (June 2013). Plus, they also include specific best practices we’ve identified through the ANSI standards process.
Dietary Supplements
The dietary supplements audit standards contain the following GMP regulations as normative references:
- 21 CFR 111
- 21 CFR 117 (HACCP)
- 21 CFR 1.906
- 21 CFR 1.908
- 21 CFR 11
- 21 CFR 1.511
- Plus 14 additional best practices
You can access the full standards by either purchasing the NSF/ANSI 455-2 Dietary Supplement Standard or by becoming a GRMA member. All GRMA members have complimentary access to these standards.
Over-the-Counter Drugs
The over-the-counter drug audit standards contain the following GMPs, regulations, and standards as normative references:
- 21 CFR 210-211
- 21 CFR 11
- 21 CFR Part 7 Subpart C
- ICH Q7
- ICH Q10
- BRC 2015, Global Standard for Food Safety, Issue 7
- FDA Process Validation Guidance
- Plus 10 additional best practices
You can access the full standards by either purchasing the NSF/ANSI 455-4 Over-the-Counter Drugs Standard or by becoming a GRMA member. All GRMA members have complimentary access to these standards.
Cosmetics
The cosmetic audit standards contain the following GMPs as normative references:
- FDA Cosmetic GMP Guidance (June 2013)
- ISO 22716:2007
- Plus 5 additional best practices
You can access the full standards by either purchasing the NSF/ANSI 455-3 Cosmetic Standard or by becoming a GRMA member. All GRMA members have complimentary access to these standards.
Interested in scheduling an audit for these product categories?
Each of our fully approved and accredited Certification Bodies conducts certification audits that evaluate the conformance to these standards and best practices. At this time, only active GRMA members can schedule audits with these Certification Bodies.
Want to stay updated on future GRMA developments?
Our commitment to advancing quality and safety standards means two things. We’re continuously improving and looking for new opportunities to promote safety. Part of that involves potentially expanding into other health and wellness categories, like medical devices and consumer products.
To stay up-to-date on the latest product categories from the GRMA, please join our mailing list.