Hundreds (if not thousands) of laws and regulations, and best federal and local practices govern the natural products industry. Within that growing and changing body of regulations, current Good Manufacturing Practices (cGMP for supplements and GMP for foods) serve as
a the key regulatory backbone for the industry.
GMP or cGMP are codified in 21 CFR 111 as a set of best practices for the manufacture, holding, distribution and warehousing of dietary supplements in the United States. So, cGMPs require that products are consistently produced and controlled to meet detailed quality standards.
Additionally, cGMPs embody the concept of quality assurance. Every stage of dietary supplement manufacturing, holding, distributing and warehousing must meet a host of quality standards appropriate to the intended product use. These safeguards aim to reduce the risks inherent to all food and nutritional products by controlling production and distribution through evaluative audits.
1. How do cGMP audits work?
In cGMP audits, a representative visits the company and provides a quality system and GMP standards overview. The auditor reviews all aspects of the operation and conducts a gap analysis to identify any shortcomings.
2. What is the evaluation process?
21 CFR 111 regulations (cGMPs and GMPs) are created, maintained and updated by the United States Food and Drug Administration (FDA). These regulations establish the basic requirements for dietary supplement companies engaged in any aspect of production or distribution. The regulations are extensive, covering everything from formulation, qualifying suppliers and ingredients, label claims and design, packaging, all manufacturing steps, cleaning and maintenance, training employees, personnel hygiene practices, product specifications, quality control reviews, distribution records and so on – all of which must be performed pursuant to Standard Operating Procedures. Performance must be adequately documented.
The FDA does not certify manufacturers, but several third party certifiers offer this service. Manufacturers seeking certification must voluntarily disclose manufacturing facility information, records, and practices to a comprehensive audit conducted by an external organization. If the manufacturer passes the annual audit, they will earn cGMP certification.
During an audit, team auditors will physically inspect and audit all procedures, documents and qualifications of employees related to dietary supplement manufacturing. As a result, this process may take several days.
Some reputable third party certifiers:
- NSF (National Science Foundation)
- NPA Certification by the Natural Products Association
- USP Certification by the United States Pharmacopoeia
- Pharmaceutical Consulting Services
3. Why obtain NSF International’s Certified for Sport Seal?
Companies committed to providing athletes with a clean, safe product
; while promoting fair play in sports , may want to obtain this seal.
Products with this seal undergo additional scrutiny and are subject to two annual quality control audits that include:
- Testing for substances prohibited by the WADA (World Anti-Doping Agency) in the final product or ingredients.
- Verifying the presence of content claims made on the label and protecting against adulteration and fraud.
- Ensuring that they do not contain unsafe contaminants.
- A cGMP certified facility manufacturers the product.
4. Which manufacturer should I choose?
Choose a cGMP certified manufacturing partner with proof of audits by an external organization such as NSF.
That’s 95% of what you need to know about cGMP certifications. However, ask the manufacturer as many questions as necessary to obtain the relevant information to make an informed decision.
These may include: years of experience, references, certifications, specifications and how many rounds of tests are performed. Also check if they supply high quality ingredients, the efficiency of their quality control, their minimum order quantity, their shipping times, and if discounts exist for large orders and repeat orders.
Ask your manufacturer specifically about the regulatory environment of the dietary supplement industry. Do they show expertise or do they struggle to answer questions? So, if it’s the latter, think twice before working with them.
In addition to this, check the details of the manufacturer’s leadership team on their website and / or social networks. In these days of operational transparency, most organizations provide this information. So, if a manufacturer lacks transparency, ask why.
5. What’s the other 5% of cGMP Certification knowledge?
- If your manufacturer can’t, or won’t, answer your cGMP questions, choose another company.
- Maintain records of all documentation you receive from your manufacturer.
- Verify that your manufacturer produced product that meets your written Product Specifications.
The right manufacturer can make the difference between your product leading the market or stagnating, between an easy or a painful process, between success and failure.
6. Finally … What are the advantages of cGMP Certification?
First, you can count on exceptional quality and manufacturing standards when you choose a certified manufacturer. This provides peace of mind that your partner will produce a product that meets your requirements. Also, if you expect your supplement to work as designed, choose a high-quality manufacturer. The cGMP certification dictates that all security measures and record keeping are in place and ensures safe and clean manufacturing.
Secondly, a supplement made in a cGMP certified facility provides greater confidence to consumers, which can build brand loyalty. Consequently, this matters as consumers become more educated and aware of the quality differences between the supplements. Many consumers seek to validate that the supplements they take have high quality standards.
A third benefit could be increased brand loyalty. Although supplements certified to meet cGMP may require a higher retail price point due to the complex cGMP standards and the cost of third party certification, displaying “Manufactured in a cGMP-certified facility” on your label can boost supplement sales.
Fourth, cGMP certified supplements can open doors. This is because most retailers and sales platforms require or will soon require that the supplements be manufactured in accordance with this standard. Consequently, don’t ignore this and let your distribution channels dry up.
Amazon has announced supplements sold on its platform must soon be cGMP certified. Also, most retailers are doing the same. This is because cGMP certification reduces liability and improves consistency and quality.
With stricter guidelines for supplement brands from retailers, like Amazon and other vendor platforms, making sure that your supplement line is manufactured in a GMP-certified facility has never been so important. Consequently, consider reducing your risk while increasing brand loyalty and customer satisfaction with cGMP certification.
Kendeyl Johansen, a tech geek and award-winning journalist, creates multimedia health and wellbeing content.
Susan Ulery utilizes her legal background plus 20 years of manufacturing expertise in the dietary supplement industry to help clients overcome regulatory challenges.