Strategy for the Validation of Methods

The validity of a specific method should be demonstrated in laboratory experiments using samples or standards that are similar to unknown samples analyzed routinely. The preparation and execution should follow a validation protocol, preferably written in a step-by-step instruction format. 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.

1. Develop a validation protocol, an operating procedure or a validation master plan for the validation
2.  For a specific validation project define owners and responsibilities
3. Develop a validation project plan
4. Define the application, purpose and scope of the method
5. Define the performance parameters and acceptance criteria
6. Define validation experiments
7. Verify relevant performance characteristics of equipment
8.  Qualify materials, e.g. standards and reagents for purity, accurate amounts and sufficient stability
9.  Perform pre-validation experiments
10. Adjust method parameters or/and acceptance criteria if necessary
11.  Perform full internal (and external) validation experiments
12.  Develop SOPs for executing the method in the routine
13.  Define criteria for revalidation
14.  Define type and frequency of system suitability tests and/or analytical quality control (AQC) checks for the routine
15.  Document validation experiments and results in the validation report