The Dietary Supplement industry is facing increased scrutiny from the U.S. Food and Drug Administration (FDA) and the mainstream media — remember Dateline NBC’s March 2012 exposé of an alleged “dry lab” serving the dietary supplement industry? Since late 2011, the FDA has seized products and shut down several manufacturers for violations of 21 CFR 111 Good Manufacturing Practices (GMPs). Federal courts are handing down hefty fines and contempt sentences to dietary supplement manufacturers and executives found to be willfully violating federal regulations. While many say this negative attention damages the industry’s reputation, others argue it’s actually good for the industry. By shining a light on the very few manufacturers who are willfully ignoring the law, reputable companies with robust quality management systems have a golden opportunity to differentiate themselves in the marketplace. If your company has embraced a culture of quality and is adhering to the current GMPs, now is the perfect time to talk publicly about it. You’ll find plenty of consumers, retailers, media and legislators ready to listen.
But what if your company hasn’t integrated quality management into every aspect of its operations? Perhaps you are the lone champion of quality in your organization. If so, there’s never been a better time to make your case for a corporate investment in quality. While it’s difficult to calculate the precise return on investment (ROI) of quality, the cost of high-profile consent decrees, FDA fines, legal battles and product recalls make a compelling financial case.
On the other hand, your company may already take quality very seriously and make every effort to adhere to the current GMPs. You may feel your company is doing everything right and you are ready for an FDA inspection today. Don’t be so sure. At NSF International’s dietary supplement training division, we’ve conducted hundreds of GMP audits against 21 CFR 111 for clients and turned up surprising — sometimes shocking — oversights in quality management practices. A few examples:
- A rubber-gloved worker handling ingredients and taking a moment to wipe his runny nose, then returning to his work wearing those same gloves.
- Inappropriate use of equipment, like the time our auditors witnessed ingredients being mixed with a hand-held drill — the kind you’d find at your local home improvement store.
- A dirty wooden pallet accidentally contaminating dietary supplement ingredients as they were poured into a mixer.
- Inadequate documentation of an otherwise thorough cleaning of a mixer. Remember the FDA mantra: If it isn’t written down, it didn’t happen.
All of these examples illustrate the importance of developing a culture of quality in your organization. It’s not as simple as hanging a quality pledge on the wall and updating your employee handbook. Quality concerns must be integrated into every step of the production process and embraced by every employee in your organization — from production line workers to senior executives. Fortunately, resources are available to help dietary supplement manufacturers develop comprehensive quality management programs and technically competent leaders that will help ensure consumer safety and avoid significant legal and financial exposure.
Training is the First Step
The courses are offered throughout the year in locations that are convenient for dietary supplement industry professionals. Courses are offered at major industry trade shows and in dietary supplement industry hotspots such as Arizona, California, New York, Salt Lake City and Florida.
NSF Dietary Supplements Training and Education course are:
- An overview of 21 CFR 111 GMP (Good Manufacturing Practices)
- Standard operating procedures and recordkeeping for compliance to 21 CFR 111
- How to prepare for an FDA inspection
- Corrective action management
- Testing method selection, specification setting and equipment qualification
- Stability program development
- Vendor qualification and audit training
- Cleaning and control of cross-contamination
- Risk assessment and risk management
- Process definition and control; facility/utilities design and monitoring
- Staff recruitment and internal training development
- International regulatory requirements for dietary supplements
NSF International is the official trainer of the 2014 Supply Side West trade show. This year NSF is offering seven courses prior to the event this year; visit https://west.supplysideshow.com/gmp-training.aspx to register.
- GMP 21 CFR 111 Overview
- Botanical Testing
- FDA Inspection Readiness
- Batch Production Records – Do’s and Don’ts
- SOP and Record Keeping for Compliance to 21 CFR 111
- The Top 10 Ways to Get a Warning Letter
- NDI’s and GRAS Notification
It may be difficult to quantify the precise ROI, but it’s hard to argue against the value of quality training for dietary supplement industry professionals. For more information about the NSF Dietary Supplements Training Program and a calendar of upcoming training dates and locations, please visit the training website, call +1 734 827-6856 or e-mail firstname.lastname@example.org