What does the new FDA rule regarding identification of botanical ingredients say?
The final rule from the FDA regarding dietary supplements establishes cGMPs for manufacturing, packaging, labeling, or holding operations. As part of the new cGMPs, the FDA has stated that 100% of raw materials used in manufacturing dietary supplements must be identified. It also states that manufacturers must use methods of testing that are scientifically valid and appropriate.
Why do I need HPTLC?
HPTLC is the only technique that offers a complete solution for compliance with the 100% identity test rule. There is simply no other available single technique that is recognized as being fully compliant that allows for 100% identification of all incoming raw materials in any form (whole, powdered, or extract).
Should I be concerned that the FDA will inspect my company for compliance?
The answer is a resounding YES! The FDA has recently begun stepping up inspections due to the fact that ALL companies are now required to be compliant, regardless of size. In addition, recent reports regarding the safety and quality of dietary supplements in mainstream media have put more pressure on the FDA to act. Noncompliance can result in fines, or worse!
What services are offered by CAMAG in addition to instrumentation?
CAMAG offers a wide range of services to help you comply with the new rules. We will help you determine what you need in order to get your lab up and running, and we will install a complete HPTLC solution. Our internal laboratory will aid your lab in any way possible to help you get the most out of your equipment, and our service department will ensure that your equipment continues to operate smoothly.
What about the need for methods?
We currently offer 150 finished methods for common botanicals. These methods are plug and play with our software and allow you to hit the ground running on your way to compliance. Each method contains the appropriate reference image for that particular botanical, thus reducing the need to buy your own reference materials. These methods will also give your lab the needed templates to create your own methods in the future.
What about the need for reference materials and standards?
While our methods collection can reduce the need for reference materials, some standards and references will still need to be purchased. Our laboratory can help you source some of these materials through our many industry contacts. Also, once a reference or standard has been analyzed and imaged by our software, this image can now serve as the reference/standard. This will save money, time, and trouble.
Why should I do ID in-house versus outsourcing?
Performing your identification in-house will help ensure tighter controls over the process, thus making your company less vulnerable to time delays and potential future problems. Remember, the final FDA rule states that the responsibility lies with the manufacturer, not the lab that performed the testing. So if an inspection occurs and your company is found deficient, your company is to blame (not the contract lab). Additionally, over time the expenses associated with outsourcing can surpass that of in-house testing.
My company doesn't currently have a lab. What should we do?
No problem! We have the experience and expertise to help you get started setting up your own lab. Just contact us to find out what we can do to help!
We don't know anything about performing HPTLC. What should we do?
We offer specialized training in our fully equipped lab for very reasonable rates, and we will even come to your facility and train you with your new equipment. Our lab manager, Judy Nichols, has over 10 years of experience of identifying botanicals via HPTLC and has already helped many new customers start building their own botanical methods collection.
