1. As an ingredient supplier, no doubt your quality programs have come under scrutiny recently? Are your clients asking different questions now? Such as? How are you responding?
Bergstrom Nutrition has been GMP certified since 2000 through Natural Products Association (NPA). Since the promulgation of the new FDA GMP’s, we have seen increased interest in our quality program, specifically in the area of GMP compliance. The increased interest is coming more from small and mid-sized dietary supplement manufacturers than from the larger companies. We encourage inquiries about our quality systems and GMP program. We also invite customer visits and audits of our MSM manufacturing plant in Vancouver, Washington.
2. Is there a question(s) you wish they’d ask?
Bergstrom Nutrition is a raw material ingredient supplier and 21 CFR Part 111 does not require raw material suppliers to follow dietary supplement GMP’s. We have been and will continue to be GMP compliant and certified. Some customers have asked why we would go to that trouble if we weren’t required to be certified. We would like other customers to ask that same question. We encourage dietary supplement manufacturers to ask about our product quality and to visit our plant. We would also like customers and potential customers who request information from us to use the SIDI protocol for information exchange.
3. Are more of your customers asking to audit your facility?
Surprisingly, the customer audit frequency has not increased since the FDA GMP’s were issued, but we expect that to change. We believe that, as the mid-sized and smaller companies gear up to comply with the GMP regulations, we will see an increase in audit activity.
4. How do you differentiate yourself based on your approach to QA and QC? What product (company) behavior / parameter(s) do you have that help differentiate your offering?
Bergstrom Nutrition was founded (as Cardinal Nutrition) to provide the highest quality MSM available. We have never varied from that early ideal. Every lot of MSM that has ever left our plant has been analyzed and passed our specifications for physico-chemical, micro biological, and heavy metal standards. Twenty years ago, the use of MSM as a dietary supplement was pioneered by Bergstrom (as Cardinal Nutrition). We continue to provide the highest quality MSM available, manufactured in our own, single purpose facility.
5. How does shelf-life testing (or accelerated stability) factor into your program?
Bergstrom Nutrition has done stability testing for many years, on samples from as far back as the first batches of MSM made back in 1989. We continue to periodically test historic samples. We have found no change in samples tested that were over 10 years old.
6. If a customer requests you allocate a lot or batch for them, how do you respond? Will this requirement or behavior increase, do you think?
Yes, we have already seen this behavior increase. We have had requests for certain particle size distributions, specific container sizes and whole lots. Because Bergstrom Nutrition handles sales, marketing, production, technical support, and distribution out of one location, we can respond very quickly to customer’s wants and needs. If a salesperson or customer service person receives a request from a customer, she has only as short walk to discuss the request with the manufacturing manager or vice president of operations.
7. Are you using or being requested to use the ‘SIDI’ program?
Bergstrom Nutrition is a strong supporter of the SIDI program. We believe very strongly in the SIDI program as an efficient way to share information in a standardized way. We have completed the “Ingredient” portion of the program and made it available to our customers shortly after it was published on industry websites. We are currently discussing potential modifications in the “Facility” portion of the program with some of the key players of the original draft. We have seen more requests for this protocol since the first of the year. We would encourage all companies in the dietary supplement industry to adopt the SIDI protocol.
8. Are your clients asking you the ‘country of origin’ question? How are you responding?
We have seen an increased interest in the “country of origin”, since the import problems made the news last year. Our label says “Made in USA” and we are very proud to supply an American made product. We invite any customer to visit our plant in Vancouver, Washington, and we include a “Country of Origin” statement on our Certificate of Analysis.
9. Who in your company is the final authority on QA issues? What is their background?
Although I am the final QA authority at Bergstrom Nutrition, most of the important decisions are made by a group made up of director of RA/QA, the vice president of operations, the manufacturing manager, the director of quality control, and the process engineer.
I have been involved with MSM for many years. I have a chemical engineering degree from Oregon State University, and as part of my 35 years as a chemical engineer, I developed the first distillation process for MSM in the late 1980’s. At Bergstrom, I helped develop the existing quality program, which led to NPA GMP certification in 2000, recertification in 2003, and recertification again in 2007. I have attended numerous NPA, EAS Consulting, and UNPA GMP seminars. I have also been involved in many customer audits.
10. What major investments have you made in ‘quality’, QA/QC in the past year? What do you plan in the near future?
At Bergstrom Nutrition, we are continually focused on continuous improvement, including process, quality, safety, and logistics improvements. In the past year, we invested in a new blending system to improve the consistency of our flow agent blending and convert our blending system from batch to continuous. This year, we will be adding a new engineer position so I can focus more on quality assurance and GMP compliance.
11. What do you see emerging as a critical QC/QA issue with your key product or product categories?
The most critical emerging issue is the effects of the new FDA GMP’s that were promulgated last year. This changes GMP compliance from voluntary to mandatory, which may potentially cause compliance issues for some dietary supplement companies. As part of the new GMP’s, dietary supplement manufacturers will have to more closely scrutinize their raw material ingredient suppliers. GMP certified ingredient suppliers should make life easier for manufacturers.
The larger issue driving the new regulations is bolstering consumer confidence in dietary supplements. Consumers are very aware of product safety, especially in the last year. The media attention on contaminated imported products has put the retailer in the hot seat and they are looking for answers on the safety and efficacy of the products they carry. Manufacturers, in turn are looking to their ingredient suppliers for assurance. There will be some shake-out in the industry, but that’s not a bad thing. Any raw material manufacturer that doesn’t provide a consistent and pure product will be held accountable by the manufacturers. Ultimately, we believe the FDA GMP’s will help improve customer confidence in dietary supplements.
12. Are there standards, reference materials and validated methods and are they appropriately used? How do you validate the methods you use internally? What support do you offer clients in this area?
All of our analytical is performed by independent third party analytical laboratories. We perform physical audits of these laboratories on a regular basis. We’ve taken our testing one step further by having one of our contract laboratories develop a SLV (single lab validation) method for MSM, which provides a compendial method for the volatile purity of MSM. We then had the method evaluated by another lab as mini-collaboration.
On an industry level, Bergstrom is currently involved with AOAC for the development of two official methods for analyzing MSM. One is for Assay and the other for low level detection of DMSO which is a raw material in MSM production. These methods have completed the SLV stage and are now in the collaborative study stage.
13. Should companies pay for quality or should it be the price of admission?
Quality should be important to everyone, from the raw material supplier all the way to the consumer. Quality in the dietary supplement industry is not free, but the cost of poor quality may turn out to be much higher. Unfortunately, the consumer does not always have a way to know the difference in quality of their dietary supplement as it sits on the shelf, so they often buy on price.
14. Where are the weakest points in the supply chain from source to shelf? What is the most significant quality gap in our industry?
Some raw materials are only available through foreign sources. Unfortunately, this can create uncertainties around quality, reliability of supply and logistics. As evidenced by some of the big news stories in 2007, quality of some foreign goods is one of the most significant quality gaps in our industry. That should improve as many foreign countries are beginning to put more emphasis on the quality of exported products.
15. How do you feel about the change from voluntary GMP’s to mandatory GMP’s?
Although many companies in the industry have chosen to be certified under voluntary GMP’s, there has been a public perception that the dietary supplement industry is unregulated. The FDA mandatory GMP’s should change the perception of the industry being unregulated. Even though it took a long time to issue the final rule, the FDA did a good job of getting industry feedback when developing the final GMP’s. The 21 CFR 111 preamble is over 700 pages long and addresses over 350 comments received from industry and others.
16. Do you expect some ingredient suppliers to go out of business due to the mandatory GMP’s and other expectations related to quality?
Yes, increased federal regulations will inevitably cause business disruption, usually to smaller companies that cannot afford the additional resources required to comply. In the preamble of the new GMP’s, the FDA estimates that 140 very small and 32 small dietary supplement manufacturers will be at risk of going out of business (Federal Register – Vol. 72, No. 121, p34938)
17. Do you have customers who demand quality, but don’t want to pay for it?
Every company has the same challenge: to provide a quality product while minimizing cost and creating the best possible return for the stakeholders. No dietary supplement manufacturer wants quality related problems, but some are more willing to take chances on raw materials than others. Manufacturers buy MSM from us because of the assurance of quality raw material. Most of these manufacturers understand that quality is not free, but some do seem to expect a quality raw material at a reduced price.
18. Will COA’s become more stringent and reliable?
The new FDA GMP’s allow a manufacturer to rely on a certificate of analysis (COA) in place of “appropriate tests or examinations” provided that a number of criteria are met. Relying on a COA could decrease raw material testing costs for many manufacturers, but it will increase the value and scrutiny of the COA; the regulation stipulates that the manufacturer must qualify the supplier by establishing the reliability of the supplier’s COA, document the qualifications, and periodically re-qualify the supplier. To be used in lieu of testing, the COA must include the test methods used, the limits of the test, and the results of the tests.