dating in the middle ages - Validating chromatographic methods

The preparation and execution should follow a validation protocol, preferably written in a step-by-step instruction format.Possible steps for a complete method validation are listed in Table 1.

validating chromatographic methods-47

Validating chromatographic methods

The scope of the method and its validation criteria should be defined early in the process.

These include the following questions: The method’s performance characteristics should be based on the intended use of the method.

It also describes what is important when transferring a method.

The validity of a specific method should be demonstrated in laboratory experiments using samples or standards that are similar to unknown samples analyzed routinely.

Initial parameters should be chosen according to the analyst’s experience and best judgment.

Final parameters should be agreed between the lab or analytical chemist performing the validation and the lab or individual applying the method and users of the data to be generated by the method.

The key point is to develop methods for easy validation and revalidation. Krause published a guide for analytical method transfer, comparability, maintenance and acceptance criteria for the testing of biopharmaceuticals (18).

This primer gives a review and a strategy for the validation of analytical methods for both methods developed in-house as well as standard methods, and a recommendation on the documentation that should be produced during, and on completion of, method validation.

This proposed procedure assumes that the instrument has been selected and the method has been developed.

It meets criteria such as ease of use; ability to be automated and to be controlled by computer systems; costs per analysis; sample throughput; turnaround time; and environmental, health and safety requirements.

Satisfactory results for a method can be obtained only with equipment that is performing well.

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