cGmp

Baseline Nutritionals produces its supplements in compliance with cGMP regulations

You may have heard the term cGMP recently but don’t know why it would be relevant to you as a supplement user. Turns out it matters a great deal. Not all companies are GMP compliant and because of that you may not be getting what is promised on your supplement label.

cGMP is an industry standard that helps keep manufacturers honest. It stands for current Good Manufacturing Practice. And despite its name, cGMP is not just about manufacturing. When it comes to supplements, cGMP applies to everything in the process--up and down the line. It is a set of guidelines that provides a system of processes, procedures, and documentation to ensure that the finished product has the identity, strength, composition, quality, and purity that it claims. And, it is important for you to understand cGMP so you can know whether or not you can trust the supplements you buy.

Manufacturers, of course, are bound by it. Surprisingly, companies that just store and/or distribute supplements are also legally required to comply with GMP regulations--with the exception of brick and mortar retailers. But online retailers such as Baseline Nutritionals are bound by it. Companies that specialize in supplying raw ingredients for supplements likewise have to follow a version of GMP, as do the testing labs that verify the purity and content of the supplements you consume. It's the law, we're all required to follow cGMP. But that doesn't mean that everyone does. While most (but not all) manufacturers do and most testing labs do, it turns out that many ingredient suppliers do not (although they are required to follow Food GMP requirements), and very few retailers do. Why not?

Primarily because running a GMP compliant supplement operation is very expensive and time consuming. Following GMP really requires a full time Quality Assurance person. In fact, the FDA actually calculated the costs involved. The numbers they came up with are a bit shocking.

Small Companies (Less than 20 employees with annual revenue under $1M)

  • Set up Costs = $26,000
  • Annual Costs = $46,000

Medium Companies (20 - 500 employees with annual revenue of $5M - $10M)

  • Set up Costs = $20,000
  • Annual Costs = $184,000

When a company takes on that much cost to become compliant, it can't just eat it. They have to pass it on to their customers, which means higher prices, which means you'll be less competitive than those who aren't GMP compliant. And that's amplified up and down the chain. For example, in complying with GMP, Baseline Nutritionals is required to work only with GMP manufacturers, warehousing facilities, fulfillment houses, and testing laboratories--all of which cost more than their non-compliant counterparts, which means that each and every one of those additional costs gets added to the final retail cost.

Maintaining compliance is also a major pain. Many companies have gone out of business because they could not afford the extra time it takes or the extra cost to become compliant. Other companies have just ignored it and hope the FDA doesn't come calling. Among other things, it requires regular onsite auditing of any company we work with to make sure they are GMP compliant. And when I say auditing, I'm not talking about simply visiting and saying hi. I'm talking about anywhere from a half day to a day-and-a-half, inch-by-inch walkthrough while working your way through a staggeringly detailed check list. To give you just one idea, when auditing a manufacturing operation, we need to make sure that no tree branches are growing too close to a facility as that could be an access point for squirrels and rats into the facility. And that's just one of a number of items we have to check for even before we actually enter the facility. Trust me; it's extensive, time consuming, costly, and it's a pain.

What GMP Covers

According to the FDA's own website, current Good Manufacturing Practices (CGMPs) requires that proper controls be in place for dietary supplements so that they are processed in a consistent manner, and meet quality standards. The CGMPs apply to all domestic and foreign companies that manufacture, package, label or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distributing them in the U.S (i.e. selling them). The requirements include provisions related to the design and construction of physical plants that facilitate:

  • Maintenance
  • Cleaning
  • Proper manufacturing operations
  • Quality control procedures
  • Testing final product or incoming and in-process materials
  • Handling and recording consumer complaints
  • Maintaining records

Anybody involved in manufacturing and distributing dietary supplements is required to keep detailed records documenting all standard operating procedures (SOPs) and they must have a formal process for reviewing and updating SOPs. In addition, training records for all employees must be kept current and a master manufacturing record for all formulas must be maintained.

Regardless, cGMP compliance requires extensive record keeping and requires access to these records by the FDA on demand. Identity testing is performed on every dietary ingredient used in each and every batch of a formulation.

cGMP Compliance for Retailers

GMP compliance for online retailers is different and only slightly less complex. In fact, it is largely designed to govern the interface between the manufacturing process and the retailing process. For example, GMP requires that companies like Baseline Nutritionals keep a Master Formula record for every product they create and sell. This record contains complete details as to exactly what the specifications are for every ingredient that goes into the formula, not to mention precise instructions as to exactly how the formula is to be packed and any scoops or droppers required.

When a purchase order is submitted to the manufacturer they are required to verify that they have precisely matched it before completing the order. In addition, label verification is required for every product, every batch, to make sure that what's in the bottle matches what's on the label. We require a C of A listing all the ingredients and harvesting status (if applicable) matched against the formula. Once we have verified that it does it can be shipped to fulfillment. Once the product arrives “retain samples” are sent to Quality Assurance.

We are required to keep multiple samples of every batch of every formula in storage in case any retesting of those batches is required. An extra sample of each product is sent for a personal product inspection by Quality Insurance before it is released to the public.

And finally, as mentioned earlier, GMP requires that we audit all manufacturing operations with onsite inspections. This not only increases cost for the online retailer that is in compliance and has go do the audits with all its manufacturers, but think what it means for the manufacturer. Let's assume that you do manufacturing for a couple of hundred companies--some small, some large. Theoretically, each and every one of them now has to regularly visit your facility for an audit. You could literally have outsiders walking through your facility every day of the year, not to mention a full time person working quality assurance with those clients. These added costs, of course, get passed on to your clients, who then pass them on to their customers. In other words, cGMP compliance costs money, and we're not done yet.

GMP Compliance for Testing Labs

If you're GMP compliant, testing takes place at every level of the process and for multiple things such as the ingredients inside the canister conforming to the label, along with a number of other things as required by cGMP. cGMP does not require a company to test their finished product for heavy metals. However, Baseline Nutritionals goes the extra mile and does tests every batch of every product for heavy metals.

As already mentioned, before manufacturing a product, every ingredient is tested to make sure it's what it's supposed to be, not something merely similar, or something that merely looks like what you want. For example, if you're putting Panax ginseng in a product, you have to run it through testing to make sure the ingredient supplier hasn't sent you Siberian ginseng by mistake. They are very different plants (Siberian ginseng isn't actually even ginseng; it's Elutherococcus), with very different bioactives. Siberian ginseng is also much cheaper, and ingredient suppliers sometimes do "accidentally" confuse the two. The bottom line is that if you want to verify that you're getting what your formula calls for, you have to test each ingredient as it comes in. This is a GMP requirement. If you're not GMP compliant, you don't do it, and you save money. Then again, your final formula may not be what you think it is and may not match what's on the label.

In addition, both ingredients and final products need to be tested for micros. That is, they need to be tested for bacterial contamination such as E. coli and salmonella. This is crucial, especially if you're dealing with any ingredients that were once alive or grown--no matter how organic the source. And again, it's a GMP requirement.

After a product has been manufactured, but before you sell it to the public, it's a good idea to test it with an ISO accredited, GMP compliant, third party, independent laboratory for heavy metal contamination. (As mentioned above, this is something that Baseline Nutritionals does as a matter of course with every batch of every product we sell. Yes, it costs more to send products out for testing to certified testing labs, but Jon insists that Baseline take its mission statement--When Compromise Is Not an Option--very seriously. He doesn’t make his formulations for the casual supplement user, but for those who insist on using the best. And when it comes to testing laboratories, there are several levels of qualification for determining which lab to use. In descending order, they are:

  1. ISO/IEC 17025:2005 accredited2 (International Organization for Standardization). Accreditation is actually done on a test by test basis. In other words, a lab can be accredited to run tests on only a handful of heavy metals, or on the whole gamut. Testing for protein, for example, requires a separate accreditation.
  2. cGMP compliant
  3. GLP (Good Laboratory Practices) compliant
  4. Having some equipment and doing your own thing

Does GMP Matter?

So, we now know that GMP makes products more expensive, is a pain in the butt to implement and enforce, and has huge gaps that negate much of its value. But we're still left with the bottom line question: Does it matter? Is it worth it?

Andrew C. von Eschenbach, the Commissioner of Food and Drugs, said the new GMP rules for dietary supplements in June of 2007 "This rule helps to ensure the quality of dietary supplements so that consumers can be confident that the products they purchase contain what is on the label."

We believe that despite its costs and deficiencies--and they are large and many--being cGMP compliant is important. It is worth the time and expense. If you're ever in a position where "compromise is not an option" when it comes to the supplements you take, would you want anything less--could you afford to settle for anything less?