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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
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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.

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Industry

Healthcare

Standard

ISO/IEC 17025 - Testing Laboratory Competence

Workspaces

Pharmaceutical Facilities

Occupations

Analytical Chemist
Method Development Specialist
Quality Control Analyst
Validation Scientist
Laboratory Manager
1
Is the accuracy of the method validated against known standards?
2
What is the precision of the method (RSD)?
Min: 0
Target: 5
Max: 100
3
Does the method exhibit specificity for the target analyte?
4
Rate the linearity of the method based on the calibration curve.

1

2

3

5

4

5
Is the measurement uncertainty of the method documented?
6
Provide details of the validation protocol used.
7
What is the detection limit of the method?
Min: 0
Target: 0.01
Max: 10
8
Is the overall validation status of the method satisfactory?
9
Was robustness testing performed for the analytical method?
10
What is the acceptable temperature range during testing?
Min: 0
Target: 25
Max: 100
11
Describe any matrix effects observed during validation.
12
Was the reproducibility of the method confirmed?
13
Is the analytical method compliant with ISO 17025 standards?
14
What is the sample size used for validation studies?
Min: 1
Target: 30
Max: 100
15
Detail any deviations from the approved validation protocol.
16
Has the method received final approval from the regulatory body?

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 of ISO 17025 Method Validation Checklist for Pharmaceutical Testing

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