Contract Supplement Manufacturer
If you’re a small supplement manufacturer, you face a whole new set of challenges starting this June. On June 25, small supplement and vitamin manufacturers join large and medium sized companies in being required to meet the FDA’s current good manufacturing practices (GMPs).
These GMPs are actually a long time coming. When it was passed in 1994, the Dietary Supplement and Health Education Act (DSHEA) required that the FDA establish and enforcing GMPs. But it wasn’t until 13 years later, in 2007, that the FDA finally itemized them. In 2008 the FDA began enforcing them with large manufacturers, followed by medium-sized manufacturers in 2009.
Now, it’s your turn.
For Small Vitamin Manufacturers, GMPs Bring Benefits As Well As Challenges
While to some extent these regulations may seem onerous, they actually are a boon to an industry challenged by uneven standards and the consumer mistrust that comes with it. For this reason, many companies have welcomed the enforcement of these long overdue regulations. Industry experts predict that the enforcement of GMPs will improve the industry’s image and boost the already steady market growth for nutritional supplements.
Nonetheless, making sure you survive this tricky year may require some major changes in your production process. And it certainly means that you need to have a solid manufacturing partner who is ready to help you meet compliance without a hitch.
To make sure you have the right partner, here are three strategic questions to ask them about GMP compliance:
1. What has been your history of applying GMPs to your manufacturing process and what are you doing now to insure you’re compliant?
Long before the FDA’s GMPs went into effect in 2007, many quality manufacturers followed good manufacturing practices borrowed from the pharmaceutical industry, other countries, or established informally within the nutrition industry itself.
It’s certainly possible that some companies will be able to establish compliance with limited adherence prior to the establishment of FDA guidelines. But there are clear advantages to working with a partner who has made most of the move already:
A company that has been following GMP guidelines before the FDA enforced them is more likely to have a core commitment to quality. Wouldn’t you rather work with a manufacturer who has on its own invested in quality control rather than one forced into it by regulation?
Secondly, having the right equipment is one thing . . . Having personnel experienced in using the equipment is another . . . And having a company culture created by these experienced people – a culture that already focuses on looking for problems, spotting them and attending to them – is even better.
Applying GMPs effectively to manufacturing takes more than just new equipment or even new personnel. It takes a company that has woven good manufacturing into the way it operates. With well-tested systems and experienced people in place, it can meet GMP requirements effectively.
2. Do you use any form of internal auditing to catch problems before an outside inspection does?
At one point or other, the supplement manufacturer you’re working with will have an FDA inspection of the plant. Hopefully this will go smoothly with maybe a few recommendations, but no major problems.
However, the only way to ensure that there are no disturbing surprises is to be proactive by checking for compliance before the inspector comes. To this end, see if your supplement manufacturer has set up an internal audit system.
With this system, an internal audit team regularly pays surprise visits to various departments and assesses their performance. The team’s reports help to initiate discussions, fix problems and improve production procedures. Best of all, this happens before you have an FDA inspector breathing down your neck.
3. How will the implementation of these regulations affect my production costs and schedule?
Just about all vitamin manufacturers have had to make some adjustment to meet new regulations. This includes expenses like new equipment, new facilities, or hiring new personnel. And these requirements have also brought new schedules to accommodate new procedures or added steps like raw materials analysis. Both the cost and the scheduling can end up affecting your production costs and schedule.
These new expenses are unavoidable. Some companies will not be able to meet the new costs and will end up closing as a result. The ones that pull through, on the other hand, can look forward to increased consumer confidence that can only boost the nutritional supplement industry’s steady growth.
In the short run, a good partner will not only share the increased financial burden with you but will also work with you to look for cost savings. Perhaps it means securing new raw ingredients or scaling up your production to larger runs. Perhaps it means identifying new packaging that will help you save on shipping.
A good supplement manufacturer will help you look for alternatives that can help you continue production in a timely manner without losing a healthy profit margin.
For A Productive Partnership, Ask Your Supplement Manufacturer These Questions
Meeting these new requirements will challenge your business on many fronts. By partnering with a good contract manufacturer, however, you can streamline the adjustments to these changes and ensure your products and business are compliant.
If you’re already working with a contract manufacturer, ask your partner these three questions. By doing so, you’ll gain a deeper insight not only into their ability to meet GMP requirements, but also their commitment to work with you in developing high quality products and a strong business. This discussion will make your partnership a productive one.
On the other hand, if your contract supplement manufacturer partner cannot help you meet these requirements to your satisfaction, look for one who can. You’ll avoid countless headaches by finding a solid GMP-compliant manufacturer. Use these questions as part of your initial interview process.
Or call us at (800) 233-2112 We’re looking forward to working with you.
To learn more about how contract supplement manufacturer, Vitakem Nutraceutical, Inc., works with small companies to help them meet GMP requirements and build a solid business call 800-233-2112. Or visit our website at www.vitakem.com.