The food supplement industry is one of the fastest growing industries in America and abroad. It is little wonder that new supplement lines are sprouting up all over the place.For scrutinizing practitioners who want and need to provide the absolute best for their patients, how does one wade through the marketing to determine quality that is worthy of the clinical setting?
As I embark upon this subject, let me say up front that you should not take my word for any of what I’m about to tell you. I have worked in the supplement industry for 15 years now and have been privy to information to which most practitioners are not exposed. But in that I could rightfully be accused of having biases because of my associations, I encourage you to check out my claims for yourself.
Good Manufacturing Practices (GMP)
One of the most important markers of quality in supplement manufacturing that a scrutinizing practitioner needs to know about is Good Manufacturing Practices (GMP). There are three entities that offer GMP certifications. They are the Natural Products Association (NPA), the Therapeutic Goods Association (TGA), and the National Sanitation Foundation (NSF). These organizations are reliable third-party sources of gold standard analysis on the quality of supplement manufacturing. Their analysis involves random audits that scrutinize areas that most practitioners would not even know to ask about, such as determining if the kind of paint used on the walls is producing off-gassing, whether or not the water is ultra-purified, analyzing the joining of walls to the floor to make sure that there is a gradual and sloped transition so that no dust can gather in the corners, analyzing the machinery and the operating systems, and testing the knowledge of the people running machines to make sure that each person’s procedures matches GMP standards.
This is merely a partial list, as a GMP audit usually takes up to two weeks to complete, and companies seeking GMP certification do not know when the audit is going to take place. The auditors simply show up unannounced, so the company had better be operating according to those standards 24/7 to score a passing grade.
The primary goal of GMP is to ensure that the manufacturing processes operate in a state of control. This state of control acts as a filter to help eliminate product contamination, mix-ups, and errors. GMP certification offers health professionals and their patients a basis for trust that the supplements they are using are safe and match label claim.
GMP is Good Business
GMP certification is good business for both the company in question and the doctors and patients using their products because it reduces exposure to potential product liability issues. Remember, in today’s culture anyone can sue anyone for almost anything. If a patient ever sought legal actions against a doctor for his or her administration of a certain nutritional product, the backing of GMP certification that is consistent with how drug companies manufacture their products could help protect both the doctor and the supplement company.
Also, GMP certification reduces exposure to regulatory enforcement actions.
I have included the GMP framework at the end of this post for those interested in learning more.
Aren't All Supplement Lines Operating with High Standards?
It takes multiple millions of dollars to get a manufacturing system and facility up to the very stringent GMP standards, but the certification itself costs only $200. Many companies claim that they are “GMP compliant,” or “operate according to GMP standards,” but these claim beg an important question. If a company has already spent the millions of dollars it takes to get up to GMP standards, why would they not spend another $200 to validate their quality claims by getting certified? As it appears to me (for whatever my opinion is worth), the companies who are not certified remain that way because either they know up front that they cannot pass the audits, or because they have already attempted to get certified but failed the stringent auditing process.
As it currently stands, there are only two doctor’s lines that maintain GMP status, and there is still only one doctor’s line that is certified on all three levels.
Yeah, but…
One common argument against GMP certification used by non-GMP companies is that the GMP process doesn’t take into consideration ingredient selection. In other words, an aspirin or calcium carbonate product can be GMP certified. So ingredient selection and product design certainly play an important role.
I agree that GMP is not an all-encompassing standard of what differentiates a quality line from those that are not. However, GMP is like a doctor who has a certified degree offering treatment versus someone like myself who has some knowledge of healthcare but has no license. A scrutinizing patient would and should raise an eyebrow at a person who said, “Well, I have all the knowledge that any other practitioner has, I just never got my license. But you can trust me because I offer the same care that any licensed practitioner would.” In order to validate the knowledge, training, and skill of any person offering healthcare, a license or certification must be in hand.
Similarly, a scrutinizing practitioner should also raise an eyebrow at a company who claims to operate according to GMP standards but never bothered to get certified. A product line can be making great choices in terms of their ingredient selection but then fail in other vital quality procedures. What good is the best Ginko raw material, for example, if the manufacturing process fails in many important markers of quality determined by the GMP certification process? If a company will not invest the $200 it takes to get GMP certified, then it should not be assumed that that company is operating on that level of quality in spite of what they claim. Nor should it be assumed that that company is doing the due diligence in other areas of quality not analyzed by GMP.
Remember, every supplement company is in business to make money, and talk is cheap. A practitioner really has no idea what goes on behind closed doors unless the system in place is analyzed, scrutinized, and certified by a reliable and recognized third-party placing their stamp of approval on the operating system. And that’s why GMP is important.
In the next post, I’ll address a few other important determinants of quality.
________________________
The GMP framework involves:
Technical Controls
-Materials
-Buildings
-Equipments
Operational Controls
-Policies
-Procedures
-Records
Relational Controls
-People (Employees and Suppliers)
GMP controls include the use of procedures that control each step and records that confirm procedures were followed and provide traceability in the following areas:
· Receipt and storage of raw materials, in-process materials and finished product.
· Manufacturing process
· Testing (raw materials, in-process and finished product)
· Filling, labeling and packaging
· Finished product approval
· Document Review
· Release and distribution
· Change control
As it currently stands, there are only two doctor’s lines that maintain GMP status, and there is still only one doctor’s line that is certified on all three levels.
Yeah, but…
One common argument against GMP certification used by non-GMP companies is that the GMP process doesn’t take into consideration ingredient selection. In other words, an aspirin or calcium carbonate product can be GMP certified. So ingredient selection and product design certainly play an important role.
I agree that GMP is not an all-encompassing standard of what differentiates a quality line from those that are not. However, GMP is like a doctor who has a certified degree offering treatment versus someone like myself who has some knowledge of healthcare but has no license. A scrutinizing patient would and should raise an eyebrow at a person who said, “Well, I have all the knowledge that any other practitioner has, I just never got my license. But you can trust me because I offer the same care that any licensed practitioner would.” In order to validate the knowledge, training, and skill of any person offering healthcare, a license or certification must be in hand.
Similarly, a scrutinizing practitioner should also raise an eyebrow at a company who claims to operate according to GMP standards but never bothered to get certified. A product line can be making great choices in terms of their ingredient selection but then fail in other vital quality procedures. What good is the best Ginko raw material, for example, if the manufacturing process fails in many important markers of quality determined by the GMP certification process? If a company will not invest the $200 it takes to get GMP certified, then it should not be assumed that that company is operating on that level of quality in spite of what they claim. Nor should it be assumed that that company is doing the due diligence in other areas of quality not analyzed by GMP.
Remember, every supplement company is in business to make money, and talk is cheap. A practitioner really has no idea what goes on behind closed doors unless the system in place is analyzed, scrutinized, and certified by a reliable and recognized third-party placing their stamp of approval on the operating system. And that’s why GMP is important.
In the next post, I’ll address a few other important determinants of quality.
________________________
The GMP framework involves:
Technical Controls
-Materials
-Buildings
-Equipments
Operational Controls
-Policies
-Procedures
-Records
Relational Controls
-People (Employees and Suppliers)
GMP controls include the use of procedures that control each step and records that confirm procedures were followed and provide traceability in the following areas:
· Receipt and storage of raw materials, in-process materials and finished product.
· Manufacturing process
· Testing (raw materials, in-process and finished product)
· Filling, labeling and packaging
· Finished product approval
· Document Review
· Release and distribution
· Change control
