What in the world are nutraceuticals? Simply said, they are food extracts that promote your health. A nutraceutical can be a “superfood” for instance the acai berry, or plain old garlic. Foods with medicinal properties often act as nutraceuticals to treat various ailments.
Other times a nutraceutical might contain an extract from a food source, like an Omega-3-rich fish oil extracted from salmon and other cold-water fish. Nutraceuticals are all-natural and often act as alternatives to drugs. This is often because people generally believe natural products are healthier. They are also assumed to have lesser side effects than other forms of therapy.
To ensure you are partnering with the right Vitamin Manufacturing contract manufacturer, here are the strategic questions to ask them about GMP (Good Manufacturing Practices) compliance:
Question 1
What is your history of applying GMPs to your manufacturing process and how are you insuring you’re compliant? GMPs were put into practice in 2007, and many quality manufacturers followed good manufacturing practices derived from the pharmaceutical industry or established unofficially within the nutrition industry itself.
It’s possible that some companies can establish compliance with minimal adherence before the establishment of FDA guidelines. However, there are obvious benefits to working with a partner who has made most of the move already.
A company which is already following GMP guidelines before the FDA enforced them will potentially have a no-frills commitment to quality. Wouldn’t you prefer to partner with a manufacturer who has invested in quality control on its own rather than one forced into it by regulation?
Question 2
Do you implement internal auditing to spot problems before an outside inspection does? At some point, the contract supplement manufacturer you’re working with will have an FDA inspection of the plant. Hopefully, this will run without a hitch with maybe a few recommendations.
However, to ensure that there are no surprises be preemptive by verifying for compliance before the inspector comes, which is why, identify whether or not your vitamin manufacturing contract manufacturer has put in place an internal audit system. Under this system, an internal audit team regularly visits different departments and reviews their performance. The team’s reports allow for initiating discussions, resolving problems and upgrading production procedures. The good news is this takes place before you have an FDA inspector breathing down your neck.
Question 3
How’ll the implementation of these regulations influence my cost of production and schedule? Nearly all vitamin manufacturers have had to make a little adaptation to meet new rules. This includes expenses such as new equipment, facilities, or engaging new personnel. And these requirements have further brought new schedules to entertain new procedures or steps for example raw materials analysis. The cost and the scheduling can eventually affect your production costs and schedule.
In the short term, a good partner will share the increased financial burden with you along with working with you to look for cost savings.
The Nutshell
If you’re partnering with a contract manufacturer, ask them these three questions.
