What is "scientifically valid"?
Scientifically Valid Method vs. Validated Method – What is the difference?
By Jeff Stassi - Eurofins Senior Analytical Service Manager - Dietary Supplements
The dietary supplement industry has become an increasingly regulated industry since the introduction of the dietary supplement GMPs in 2007. There has also been a distinct focus on the analytical testing procedures over the years with a number of citations that have focused on analytical testing and the validity of the test methods being used.
To this day, there still is industry confusion as to the requirements needed to comply with the dietary supplement GMP requirement to use a scientifically valid method.
Does this mean the method must be validated?
What needs to be understood is that the FDA did not define the term “scientifically valid method” in the 800-page final rule. That left the industry wondering how they would comply with the requirement if there was no established definition for the term.
What we have learned over the years for dietary supplements is that the accepted criteria for a scientifically valid method is that it must be the following:
- precise
- accurate
- specific for its intended use
- consistently does what it is intended to do
In other words, there is an aspect of validation that falls within these terms. A supplement company should, however, define what criteria is necessary within their organization to consider it a scientifically valid method. In the pharmaceutical industry, many more parameters that must be followed take it to a completely new level. Therefore, you can certainly have a scientifically valid method without having a fully validated method. Thankfully, with the complexity of the formulations in supplements, not all of these validation parameters are required.
Here are the differences that will separate the requirements of a scientifically valid method and a fully validated method.
VALIDATED METHODS
Accuracy
Precision / Repeatability
Intermediate precision / Reproducibility
Robustness / Ruggedness
Specificity
Linearity
Range
Detection Limit / Quantification limit
Degradation / forced degradation
Standard and Solution stability
SCIENTIFICALLY VALID METHOD
Accuracy
Precision / Repeatability
Intermediate precision / Reproducibility
Specificity
At Eurofins, we understand that trying to decipher what is required for your products can be a difficult task. We have experts available that will help you talk through your testing plans and discuss the methods with you so that you can determine if they meet your company's criteria for being "scientifically valid".
Want to read more about this topic?
Here is an article authored by Jeff Stassi from the "Natural Products Insider" originally published on August 15, 2013.
Scientifically Valid: Lab Testing a Major Focus for FDA
The dietary supplement industry has become an increasingly regulated industry since the 2007 introduction of cGMPs (current good manufacturing practices) for dietary supplements. This has forced many companies to dramatically increase their testing programs as well as their scientific understanding of the development of their products. One requirement that continues to elicit questions and be a source of ambiguity is the term scientifically valid." In fact, the exact requirement in FDA 21CFR Part 111, which is specific to manufacturing, packaging, labeling or holding operations for dietary supplement, states, You must ensure that the tests and examinations that you use to determine whether the specifications are met are appropriate, scientifically valid methods."
When new guidance or new terminology is introduced to industry, uncertainty often follows. It is also challenging for companies to achieve compliance when uncertainty and lack of specific direction leads to inconsistencies in how companies implement the same requirement.
The lack of definition for the term scientifically valid" has been of major discussion among dietary supplement companies, trade organizations, regulators, laboratories and industry insiders. One thing is certain, in addition to the FDA's focus on the manufacturing practices of dietary supplement companies, the agency is also emphasizing the analytical approach used to support the quality of manufactured products, from raw materials to finished products. Currently, a higher percentage of audit findings are related to laboratory operations compared to this time last year. Many of these findings indicated a deficiency in the testing, lack of sufficient and scientifically valid methods, improper identity tests, and lack of test data to support the quality of their products. Companies are being called out on these deficiencies and are looking for more analytical support.
Recently, an FDA warning letter was issued to a company because an inspector pulled a product for testing of a biotin supplement, which subsequently showed the level of biotin to be approximately 5 percent what was claimed on the label. This illustrates FDAs movement toward auditing companies and, as part of that process, testing products for compliance to label claims and nutrient content. Manufacturers must be more prepared than ever to test raw materials and finished products to ensure specifications are met and that the stated amount of each dietary ingredient is present at the level declared.
FDA places the burden of proof on the manufacturer, whether or not it tests its products in-house or with a third-party laboratory. Continue Reading...
