Single logo

ISO 17025 Method Validation Checklist for Pharmaceutical Testing

A comprehensive checklist for validating analytical methods in pharmaceutical laboratories according to ISO 17025 requirements, focusing on key validation parameters and documentation practices to ensure reliable and compliant testing procedures.

ISO 17025 Method Validation Checklist for Pharmaceutical Testing
by: audit-now
4.7

Get Template

About This Checklist

Method validation is a critical component of ISO 17025 compliance in pharmaceutical laboratories. This specialized checklist is designed to guide laboratory personnel through the comprehensive process of validating analytical methods as required by ISO 17025 standards. By addressing key validation parameters such as accuracy, precision, specificity, and robustness, this checklist ensures that pharmaceutical testing methods are fit for their intended purpose. Implementing this checklist helps laboratories demonstrate the reliability of their analytical procedures, enhance the quality of test results, and maintain compliance with regulatory requirements in the pharmaceutical industry.

Learn more

Industry

Pharmaceuticals

Standard

ISO 17025

Workspaces

Pharmaceutical Laboratory

Occupations

Analytical Chemist
Method Development Specialist
Quality Control Analyst
Validation Scientist
Laboratory Manager

Analytical Method Validation Questions

(0 / 4)

1
Rate the linearity of the method based on the calibration curve.

Select the appropriate score for linearity.

To determine how well the method responds in a linear manner to varying concentrations of analyte.

1

2

3

4

5

2
Does the method exhibit specificity for the target analyte?

Select the specificity validation result.

To confirm the method can accurately measure the target compound in the presence of other substances.
3
What is the precision of the method (RSD)?

Provide the precision measurement in percentage.

To evaluate the consistency of the method.
Min: 0
Target: 5
Max: 100
4
Is the accuracy of the method validated against known standards?

Select the accuracy assessment result.

To ensure that the method provides correct results.
5
Is the overall validation status of the method satisfactory?

Select the overall validation status.

To assess the final validation outcome based on all parameters.
6
What is the detection limit of the method?

Enter the detection limit in the appropriate unit.

To establish the lowest concentration that can be reliably measured.
Min: 0
Target: 0.01
Max: 10
7
Provide details of the validation protocol used.

Describe the validation protocol utilized.

To verify that the correct procedures and protocols are followed during validation.
8
Is the measurement uncertainty of the method documented?

Select the measurement uncertainty evaluation result.

To ensure that the method's reliability is well understood.
9
Was the reproducibility of the method confirmed?

Select the reproducibility evaluation result.

To ascertain if the method yields consistent results across different trials.
10
Describe any matrix effects observed during validation.

Provide details on any matrix effects encountered.

To identify how sample matrices might influence results.
Write something awesome...
11
What is the acceptable temperature range during testing?

Enter the acceptable temperature range in degrees Celsius.

To evaluate how temperature fluctuations affect method performance.
Min: 0
Target: 25
Max: 100
12
Was robustness testing performed for the analytical method?

Indicate whether robustness testing was conducted.

To ensure the method's performance under varied conditions.
13
Has the method received final approval from the regulatory body?

Indicate whether final approval has been obtained.

To ensure that the method is officially recognized for use.
14
Detail any deviations from the approved validation protocol.

Describe any deviations and their implications.

To document any changes that might affect validation outcomes.
Write something awesome...
15
What is the sample size used for validation studies?

Enter the sample size used for validation.

To confirm that the sample size is adequate for reliable results.
Min: 1
Target: 30
Max: 100
16
Is the analytical method compliant with ISO 17025 standards?

Select the compliance status.

To ensure the method meets required international standards for testing and calibration.

FAQs

Key validation parameters typically include accuracy, precision (repeatability and intermediate precision), specificity, linearity, range, limit of detection (LOD), limit of quantitation (LOQ), robustness, and, where applicable, stability of analytical solutions.

ISO 17025 does not specify a fixed revalidation frequency. However, methods should be revalidated when significant changes occur, such as modifications to the method, changes in equipment or reagents, or when quality control data indicate performance issues. A periodic review of method performance is also recommended.

Method validation is typically performed by qualified analytical chemists or method development specialists. However, the overall responsibility for ensuring proper validation lies with the laboratory manager or quality assurance manager, who should review and approve validation protocols and reports.

The checklist includes items to ensure that measurement uncertainty is estimated and documented as part of the method validation process. This includes considering all significant sources of uncertainty and evaluating their impact on the overall measurement result, as required by ISO 17025.

Yes, while the specific validation parameters may vary, this checklist is designed to be applicable to both chemical and microbiological testing methods. It includes general principles of method validation that can be adapted to different types of analytical procedures used in pharmaceutical laboratories.

Benefits

Ensures thorough validation of analytical methods in compliance with ISO 17025 standards

Improves the reliability and reproducibility of pharmaceutical test results

Facilitates regulatory compliance and supports method transfer between laboratories

Helps identify and address potential sources of error in analytical procedures

Enhances overall quality assurance in pharmaceutical testing processes