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Method Validation

Method validation is the process used to confirm that the analytical procedure employed for a specific test is suitable for its intended use. Results from method validation can be used to judge the quality, reliability and consistency of analytical results; it is an integral part of any good analytical practice. Analytical methods need to be validated or revalidated
  • Before their introduction into routine use;
  • Whenever the conditions change for which the method has been validated (e.g., an instrument with different characteristics or samples with a different matrix); and
  • Whenever the method is changed and the change is outside the original scope of the 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. 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. 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.
ISO/IEC 17025 definition: ‘The confirmationby examination and the provision of objective evidencethat the particular requirements for a specific intended use are fulfilled’
What is validation?

Specific intended use

– analytical requirement
– what will test method be used for? why are measurements required?

Objective evidence

– experimental data from method validation study
– information on method performance

Confirmation

– comparison of requirement with experimental evidence
Can the method deliver results that are fit for a particular purpose?
  • Good science
  • Essential for ensuring reliability of results
  • Consistent application of methods
  • Better agreement between analysts/laboratories/ countries
  • Key requirement of accreditation standards–ISO/IEC 17025
Without validation there can be no assurance that results will be fit for purpose

During method development

– is the proposed method likely to be fit for purpose?

Before using any method for analysis of test samples

– including standard/published methods which have been validated by others
– verify suitability for analytical requirement
– verify own ability to match published data

Change of application/working environment/analyst

Following period of non-use

§5.4.1 General

– laboratory shall use appropriate methods and procedures for all tests within its scope

§5.4.2 Selection of methods

– methods must meet customer requirements
– preference for standard methods (international/national standards)
– ‘laboratory shall confirm that it can properly operate standard methods before introducing the tests’
– laboratory-developed methods may be used if they are validated

ISO definition

Types of method that require validation

– (standard -§5.4.2)
– non-standard
– laboratory designed/developed
– standard methods outside normal scope
– amplified/modified standard methods

Validation required to demonstrate that methods are fit for their intended use

  • As extensive as necessary for application
  • Must record validation data and document procedures used
  • Include statement of ‘fitness for purpose’
  • Method performance must be relevant to customer needs and assessed against intended use of the method
– measurement uncertainty, detection limit, selectivity, linearity, repeatability/reproducibility, robustness

Why are the measurements required?

– what will the data be used for?

Analyte

– quantitative or qualitative
– class/total/available/species
– likely concentration

Sample

– nature (matrix)
– size

Other considerations

– destructive vs non-destructive test
– timescale
– cost

Selectivity/specificity

– am I measuring what I think I’m measuring? are there any interferences?

Precision (repeatability, reproducibility)

– how close are the results of replicate measurements made on the same sample?

Bias, recovery

– how close are the results to the ‘right’answer

Working range

– range of analyte concentrations that can be measured reliably
– limit of detection, limit of quantitation

Ruggedness/robustness

– control necessary for each stage of the procedure

DEPENDS ON THE CRITICALITY OF THE MEASUREMENT, SCOPE OF THE METHOD, LEVEL OF INFORMATION AND EXPERIENCE ALREADY AVAILABLE

Parameter Type of Analysis
Qualitative Major Component Trace Analysis Physical Property
Specficity / selectivity
Precision  
Bias  
Limit of Detection    
Limit of Quantitation      
Linearity/working range  
Ruggedness
Major component : analyte concentration in range 1-100%

Trace analysis : analyte concentration less than 100 mg/kg

Analyse data from method performance parameters

Are target values achieved?

– YES – method is fit for purpose
– NO – more development required

Method is validated by the declaration of fitness for purpose

Method validation is required to produce meaningful data

Both in-house and standard methods require validation/verification

Key requirement of ISO/IEC 17025

Validation should be a planned activity

– parameters required will vary with application

Validation is not complete without a statement of fitness for purpose

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Thanks to the dedicated team for their expertise!

Technical Director

Calibration laboratory - USA

As a calibration laboratory, maintaining the highest standards of accuracy and reliability is critical. Lakshy Management Consultant Pvt. Ltd. were instrumental in helping us achieve ISO/IEC 17025 accreditation. Their team meticulously reviewed our calibration procedures, ensured our equipment met the necessary requirements, and helped us establish traceability to national standards. We were particularly impressed with their practical approach and their ability to explain complex technical concepts in a clear and understandable way. We highly recommend their services to any calibration laboratory seeking accreditation

Lakshy Management excels in ISO 17025 accreditation guidance.

CEO

Electrical Test Lab

“Achieving ISO/IEC 17025 accreditation was a major goal for our materials testing laboratory, but the process seemed daunting. Lakshy Management Consultant Pvt. Ltd. guided us every step of the way. Their consultants were incredibly knowledgeable about the standard and helped us develop a robust quality management system. They provided practical advice, helped us optimize our testing procedures, and ensured our documentation was impeccable. Thanks to their expertise, we sailed through the accreditation audit and are now confidently providing accurate and reliable testing services to our clients.”

Lakshy Management eased ISO 17025 implementation seamlessly and efficiently.

Lab Director

The largest Pharma Company

We were struggling to meet the stringent requirements of ISO/IEC 17025 for our medical testing laboratory. Lakshy Management Consultant Pvt. Ltd. provided the expertise and support we desperately needed. Their consultants helped us improve our risk management processes, implement effective internal audits, and ensure the competency of our laboratory personnel. They were always available to answer our questions and provide guidance, making the entire accreditation process much smoother than we anticipated. We are now a fully accredited laboratory and are confident in our ability to provide high-quality testing services to our patients

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