In part two of this series, we talked about working together with the standard organizations to develop a new test method. In this part, we’ll discuss another option to consider when a testing standard doesn’t exist: develop and validate your own test method and obtain FDA approval.
Test method validation is the documented process of ensuring that a test method is appropriate for its intended use. It is essential that a test method produce reliable results so that product quality and safety can be assured.
The rigor of the test method validation should be dependent upon the risk associated with the use of the test method. Risk is the combination of the probability of harm and the severity of harm. A high level of rigor in the test method validation results in a higher level of validation credibility, thus reducing the risk associated with the use of the test method.
Test method validation is recommended when a new method is developed or an established method is revised. It can also be a useful tool to compare methods used for the same purpose.
Validating your own test method can be a quicker process than working through a standards organization. One disadvantage to this process is that you will be working without external input from industrial peers. Additionally, once the FDA deems your test method unacceptable, continuing to work with the FDA to gain their approval can be an expensive and time consuming process.
In the next part of this series, we’ll look at more options to consider when a testing standard doesn’t exist.
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