Validating test methods

But does that mean the method is more reliable and more likely to reveal your package’s potential defects?

To answer that question, you must validate that you can perform and repeat the method in your laboratory accurately with the precision necessary to identify defects particular to your package.“Only consensus methods with precision and bias [P&B] statements are cited in TIR 22, which makes those methods easier to validate,” says Johnson.

On a personal note, I have always felt very comfortable while talking to someone about research projects when the test methods used are based on a standard.

I always seem to have a strange sense of self confidence while presenting research findings or proposals when they are based on a standard rather than some in-house method.”UNIVERSAL UTILITY? If a test method has been tested for reproducibility and repeatability in several different settings, and it proves to be so, the method can be standardized.

But just because a method is listed in the annex or recognized by FDA does not mean that it will work for every medical device manufacturer and for every medical device package.

Determining the appropriateness of a particular method—and validating that method for a given package and in a given lab—is the responsibility of each medical device manufacturer.

Reads 5.2.1.2: “Test methods developed independently or from the scientific literature may be used.

Doing so enables us to use standardized test methods in our research projects.

A test can be considered an observation or experiment that determines one or more characteristics of a given sample, product, process, or service.

The purpose of testing involves a prior determination of expected observation and a comparison of that expectation to what one actually observes.

Using a standardized test method, perhaps published by a respected standards organization, is a good place to start.

Sometimes it is more useful to modify an existing test method or to develop a new one, though such home-grown test methods should be validated A well-written test method is important.

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