The pending implementation of US GMPs for supplements are causing systems to be created and questions to be asked – of suppliers and contract service providers. Other developments around the world have also focused attention on quality, quality systems and testing. We’re in the process of an ongoing dialogue with some of the world’s leading suppliers and service providers, finding out from them ‘what they’re being asked’ and what they’re doing to ensure they are prepared to meet their obligations and client needs.
An Interview with Lloyd Mangun, Director of Worldwide operations and Robert King, President & CEO, A.M. Todd Botanical Therapeutics
Our clients are asking for more detailed information regarding the product composition, regulatory status and production facilities and location. The industry is moving towards full disclosure of information. AM Todd Botanical Therapeutics is working to establish full product and production information sheets for our products.
2. Is there a question(s) you wish they’d ask?
We would like to see more companies moving in this direction.
3. Are more of your customers asking to audit your facility?
Yes. More of our customers are interested in knowing where and under what conditions the material is produced.
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?
AMTBT invests heavily in oversight of manufacturing sites.
5. How does shelf-life testing (or accelerated stability) factor into your programs?
We are performing shelf-life testing for products produced at our primary manufacturing site. This information is used to establish retest recommendations on the product information sheet.
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?
If requested, we would allocate a specific batch for a customer. We have not seen an increase in this type of request.
7. Are you using or being requested to use the ‘SIDI’ program?
Yes. We are currently using the SIDI program to revise our current product information sheets, and have also been asked by customers to use this system.
8. Are your clients asking you the ‘country of origin’ question? How are you responding?
We list country of origin as standard information on our information sheet.
9. Who in your company is the final authority on QA issues? What is their background?
Huizhen Zhang, Ph.D, Quality Assurance Manager. Dr. Zhang’s background is food science and has more than 12 years of industry experience.
10. What major investments have you made in ‘quality’, QA/QC in the past year? What do you plan in the near future?
AMTBT has invested in personnel to work directly with our suppliers and vendors to make improvements in quality at the manufacturing and laboratory level. We additionally engage third party certifications such as NSF.
11. What do you see emerging as a critical QC/QA issue with your key product or product categories?
Expanded testing and product performance evaluations.
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?
Standards and methods are drawn primarily from compendia. When necessary we work with our clients to inform them of the standards and methods used.
13. Should companies pay for quality or should it be the price of admission?
Increased quality costs more, even in low cost countries such as China. Providing a quality product should be the primary consideration over cost.
Part II: In your opinion,
1. Where are the weakest points in the supply chain from source to shelf? What is the most significant quality gap in our industry?
Full knowledge of the product source, conditions of production and testing are primary areas lacking in the industry.
2. How do you feel about the change from voluntary GMP’s to mandatory GMP’s?
Improvements in GMP standards are crucial to our industry. Mandatory GMPs are one more step toward harmonizing overall quality issues.
3. Do you expect some ingredient suppliers to go out of business due to the mandatory GMP’s and other expectations related to quality?
We believe that the passage of FDA GMPs were the beginning of the end for laptop brokers. Those ingredient companies without financial ties to China sourcing and manufacturing companies will be at an incredible disadvantage in providing ingredients to their clients in the coming months and years. The GMPs are placing a greater burden on dietary supplement final product suppliers, who have a timeframe for compliance. A portion of that burden winds up on the desk of the ingredient supplier and significantly increases his workload in supplying product. (More work, less profit)
Another significant reason for my answer of yes to the question is the insatiable appetite on the part of final product suppliers to go DIRECT to the ingredient source versus paying a multitude of middlemen. There has been a wave of this occurring since the passage of the GMPs. The middlemen of yesterday cannot provide the value being demanded without a link to the direct source.
4. Do you have customers who demand quality, but don’t want to pay for it?
Perhaps a good way to answer this question is to recognize that low cost is the concern of the purchasing department, while quality is the primary concern of the rest of the organization.
5. Will COA’s become more stringent and reliable?
C of A will become more stringent and reliable to the extent that clients purchasing ingredients demand more disclosure from their suppliers.