Why is it essential to adopt validated analysis methods?
Analytical method validation is the process of establishing documented evidence that a test procedure is fit for its intended purpose in terms of quality, reliability, and consistency, so that the same method applied in any laboratory under the same conditions yields agreeing results.
Validation Guarantees Improvement
Analytical chemistry is a science which guides you on how to get the desired information from your sample. The guidelines provided comprise of
- Selection of appropriate technique
- Procedure to be followed
- Analysis and Interpretation of data
- Environmental controls and other precautions to be adopted
You can consider yourself lucky if validated method meeting your analysis requirements is already available in your laboratory. Alternately you will have to identify the appropriate method through literature search. Your literature search will be successful if you have clarity on your analysis objectives. The search can be in the initiated using Internet search engines or referring to documented sources such as research journals. The next step is to validate the method before adopting it
What is validation?
Analytical method validation establishes documented evidence that the procedure adopted for a test is fit for the intended purpose in terms of quality, reliability and consistency of results. In other words if the same method is adopted in any other laboratories across the world under same set of conditions and control parameters the results should be in agreement
An introduction to analytical method validation details the various validation parameters which are listed below :
- Linearity
- Range
- Accuracy
- Precision
- Limit of detection
- Limit of quantitation
- Selectivity and Specificity
- Ruggedness
- Robustness
When should a method be validated?
As a regular practice any method needs to be validated before adoption. However, it would need to be revalidated under the following situations :
- Any changes made in the established procedure
- Any new accessory is added to the existing system
- The system has undergone major operational problems which have been rectified.
Benefits of method validation
Method validation is a practice which can prove to be beneficial in a number of situations such as :
- Publication of your findings in international journals of repute or presentation in professional conferences
- Instills a degree of self esteem and confidence in yourself as well as in those who use your results
- Acceptance of procedures and results by accreditation bodies and external auditors
- Arriving at critical decisions concerning use of data with regards to safe use of products by consumers
- Freedom from disputes concerning non-agreement of test results with other laboratories
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What is analytical method validation?
Analytical method validation establishes documented evidence that the procedure adopted for a test is fit for the intended purpose in terms of quality, reliability and consistency of results. It means that if the same method is used in any other laboratory across the world under the same conditions and control parameters, the results should be in agreement.
When should an analytical method be validated or revalidated?
As a regular practice, any method needs to be validated before adoption. It would need to be revalidated whenever changes are made to the established procedure, a new accessory is added to the existing system, or the system has undergone major operational problems that have since been rectified.
What parameters are assessed during method validation?
Method validation covers parameters including linearity, range, accuracy, precision, limit of detection, limit of quantitation, selectivity and specificity, ruggedness, and robustness.
What are the benefits of validating an analytical method?
Validation supports publication of findings in international journals or professional conferences, instills confidence in the analyst and in those who use the results, and helps secure acceptance of procedures and results by accreditation bodies and external auditors. It also underpins critical decisions on the safe use of products and helps avoid disputes over disagreement between test results from different laboratories.
How should you find a suitable method if a validated one is not already available?
You are fortunate if a validated method meeting your analysis requirements is already available in your laboratory. Otherwise, you will need to identify an appropriate method through a literature search using internet search engines or documented sources such as research journals, which requires clarity on your analysis objectives, and then validate that method before adopting it.