What is Pharmaceutical Grade Manufacturing? [Explained in Detail]
Lately, the nutraceutical industry has found itself under some serious scrutiny. It seems like there's a new story every other week, shining the spotlight on a once trusted supplement brand that's been featuring products that have failed to meet manufacturing standards or best practices.
In light of this most recent turn of events, many dietary supplement brand owners are looking to manufacture "pharmaceutical grade" supplements. The phrase, which has served as the fuel for a considerable amount of industry chatter, is built upon the notion that there are standards for manufacturing dietary supplements that are comparable to pharmaceutical manufacturing standards. The question becomes: Are there any facts supporting this buzz-creating idea of "pharmaceutical grade" supplement manufacturing? The answer might surprise you...
Different grades of raw materials used in products[i]:
- Pharmaceutical grade – These are raw materials that meet the pharmaceutical standards for manufacturing. They are highly pure and contain no binders, fillers, or other unknown substances.
- Food grade – These materials meet the standards for safe human ingestion and can safely come into direct contact with food products
- Feed grade – These materials meet the standards for animal ingestion
There is no such thing as "Pharmaceutical Grade" Supplement Manufacturing.
In reality, the understanding of "Pharmaceutical Grade" Manufacturing that has permeated the dietary supplement industry is nothing if not misleading. Supplement manufacturers and contract manufacturers who boast "pharmaceutical grade" capabilities are likely misinformed as to how the term can and cannot be applied to dietary supplements.
Let's take a look at what pharmaceutical-grade manufacturing really means — keeping in mind the fact that "pharmaceutical grade" can only be used in the context of the pharmaceutical industry, never for the dietary supplement industry.
What Does Pharmaceutical Grade Mean?
"Pharmaceutical Grade" refers to the manufacturing processes used by pharmaceutical companies that produce drugs and other medications. Within the pharmaceutical industry all drugs, even those that don't require a prescription, must undergo a rigorous approval process that's unique to the pharmaceutical industry. The Food and Drug Administration (FDA) makes sure that every new drug goes through a series of controlled clinical trials in order to demonstrate both safety and efficacy for its intended use. Only if the drug meets the FDA's standards of approval is it made available to the public.
Along with meeting the FDA's standards during clinical trials, a drug company must also have a unique monograph. Not unlike an industrial recipe, a monograph describes the exact procedure for making a drug, including specifications for raw materials, to ensure that the identity and efficacy of the drug are consistently maintained.
The United States Pharmacopeia and The Formulary (USP–NF) is a book of public pharmacopeial standards for chemical and biological drug substances, dosage forms, compounded preparations, excipients, medical devices, and dietary supplements. Prescription medications, in particular, must meet these USP-NF public standards for manufacturing.
Nutraceutical Industry: FDA Dietary Supplement cGMPs
As we've established, dietary supplements are not drugs, and as a result, they are not held to the same manufacturing practices. Instead, dietary supplements and other nutraceuticals are subject to their own unique set of cGMPs (current good manufacturing practices) that have been established by the FDA.
The current industry GMPs were established by the FDA in 2008 as part of a three-phase plan. Ultimately, these GMPs have been applied to all domestic and foreign companies that manufacture, package, label or hold, test, perform quality control, pack, or distribute dietary supplements for sale in the United States. The FDA has been strict in enforcing these cGMPs, actively auditing supplement manufacturers, and taking action against those who have failed to comply with federally issued warning letters.
Learn how to avoid the common regulatory mistakes that supplement brands make, from our in-house expert & nutraceuticals guru, Gene Bruno.
Partnering with a cGMP Compliant Supplement Manufacturer
One of the best ways to ensure that your products are made according to best practices is by partnering with a reputable manufacturer that has been certified GMP compliant by a trusted third-party organization such as the NSF, a widely respected and recognized global third-party certification provider. Other third-party GMP certifiers include the Natural Products Association (NPA) or the United States Pharmacopeia (USP). For a manufacturer, being third-party GMP certified means that all of their certified facilities adhere to the Current Good Manufacturing processes as have been established by the FDA.
Starting a supplement line? Here are some critical GMP questions to ask before manufacturing dietary supplements.
Frequently Asked Questions
Q: What does pharmaceutical grade mean?
A: 'Pharmaceutical Grade' refers to the manufacturing processes used by pharmaceutical companies that produce drugs and other medications. All drugs produced within the pharmaceutical industry undergo a series of controlled clinical trials and rigorous approval processes by the FDA to demonstrate safety and efficacy for public use.
Q: What is USP pharmaceutical grade?
A: The USP pharmaceutical grade is the chemical grade of a drug that meets or exceeds the purity, potency, and quality standards and requirements of the United States Pharmacopeia (USP); acceptable for food, drug and medicinal, consumption.
Q: What is omega 3 pharmaceutical grade?
A: Most fish oil or omega-3 products are labeled as 18/12 oils- 18% EPA and 12% DHA, making it a total of 30% omega- 3. The omega-3 pharmaceutical-grade refers to a stronger fish oil concentration of more than 85% of omega-3.
Q: How do you know if a supplement is pharmaceutical-grade?
A: There is no such thing as a pharmaceutical-grade supplement, as the term 'pharmaceutical grade' should be used only in the context of the pharmaceutical industry and never for the dietary supplement industry.
In the last 20 years, dietary supplement sales have more than quadrupled. Today there are more than 85,000 products available to consumers in this highly competitive market.2 While new scientific discoveries continue to give us a clear and compelling association between health and targeted nutrition, a number of adverse events and product recalls have led to quality and safety concerns resulting in negative publicity and severe scrutiny by the Food and Drug Administration (FDA). Supplement business owners can bolster their position in the market by partnering with a supplement manufacturer that works within GMP-certified facilities.
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