Steps in Method Validation
Successful acceptance of the validation parameters and performance criteria, by all parties involved, requires the cooperative efforts of several departments, including analytical development, QC, regulatory affairs and the individuals requiring the analytical data. The operating procedure or the Validation Master Plan (VMP) should clearly define the roles and responsibilities of each department involved in the validation of analytical methods.
The scope of the method and its validation criteria should be defined early in the process. These include the following questions:
- What analytes should be detected?
- What are the expected concentration levels?
- What are the sample matrices?
- Are there interfering substances expected, and, if so, should they be detected and quantified?
- Are there any specific legislative or regulatory requirements?
- Should information be qualitative or quantitative?
- What are the required detection and quantitation limits?
- What is the expected concentration range?
- What precision and accuracy is expected?
- How robust should the method be?
- Which type of equipment should be used? Is the method for one specific instrument, or should it be used by all instruments of the same type?
- Will the method be used in one specific laboratory or should it be applicable in all laboratories at one side or around the globe?
- What skills do the anticipated users of the method have?
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