HARMONIZED GUIDELINES FOR SINGLE LABORATORY VALIDATION OF METHODS OF ANALYSIS (original) (raw)
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TrAC Trends in Analytical Chemistry, 2004
It is internationally recognized that validation is necessary in analytical laboratories. The use of validated methods is important for an analytical laboratory to show its qualification and competency. In this update on analytical quality, we place validation of analytical methodologies in the broader context of quality assurance (QA). We discuss different approaches to validation, giving attention to the different characteristics of method performance. We deal with the concepts of single-laboratory or in-house validation, inter-laboratory or collaborative study, standardization, internal quality control (IQC), proficiency testing (PT), accreditation and, finally, analytical QA (AQA).
Validation of analytical methods and laboratory procedures for chemical measurements
Arhiv za higijenu rada i toksikologiju, 1998
Method validation is a key element in the establishment of reference methods and in the assessment of a laboratory's competence in producing reliable analytical data. Hence, the scope of the term "method validation" is wide, especially if one bears in mind the role of Quality Assurance/Quality Control (QA/QC). The paper puts validation in the context of the process generating chemical information, introduces basic performance parameters included in the validation processes, and evaluates current approaches to the problem. Two cases are presented in more detail: the development of European standard for chlorophenols and its validation by a full scale collaborative trial and the intralaboratory validation of a method for ethylenethiourea by using alternative analytical techniques.
Some practical examples of method validation in the analytical laboratory
TrAC Trends in Analytical Chemistry, 1999
Method validation is a key element in both the elaboration of reference methods and the assessment of a laboratory's competence in producing reliable analytical data. Hence, the scope of the term method validation is wide, especially if one bears in mind that there is or at least should be a close relation between validation, calibration and quality control QA /QC. Moreover, validation should include more than the instrumental step only since the whole cycle from sampling to the ¢nal analytical result is important in the assessment of the validity of an analytical result. In this article validation is put in the context of the process of producing chemical information. Two cases are presented in more detail: the development of a European standard for chlorophenols and its validation by a full scale collaborative trial, and the intralaboratory validation of a method for ethylenethiourea using alternative analytical techniques.
TrAC Trends in Analytical Chemistry, 2004
Credibility of analytical data has never caught the public's eye more than today. The key principle for quality and reliability of results is comparability between laboratories and on a wider, international basis. In order to be comparable, analytical results must be reported with a statement of measurement uncertainty (MU) and they must be traceable to common primary references. This work focuses on traceability and uncertainty of results. We discuss different approaches to establishing traceability and evaluating MU. We place both concepts in the broader context of analytical method validation and quality assurance. We give up-to-date information in the framework of new, more exacting European and international standards, such as those from Eurachem/CITAC, IUPAC and ISO.
Validation of Analytical Methods Provisional chapter Validation of Analytical Methods
Method validation is a key element in the establishment of reference methods and within the assessment of a laboratory's competence in generating dependable analytical records. Validation has been placed within the context of the procedure, generating chemical data. Analytical method validation, thinking about the maximum relevant processes for checking the best parameters of analytical methods, using numerous relevant overall performance indicators inclusive of selectivity, specificity, accuracy, precision, linearity, range, limit of detection (LOD), limit of quantification (LOQ), ruggedness, and robustness are severely discussed in an effort to prevent their misguided utilization and ensure scientific correctness and consistency among publications.
Analytical and Bioanalytical Chemistry, 2004
The implementation of quality systems in analytical laboratories has now, in general, been achieved. While this requirement significantly modified the way that the laboratories were run, it has also improved the quality of the results. The key idea is to use analytical procedures which produce results that fulfil the users’ needs and actually help when making decisions. This paper presents the implications of quality systems on the conception and development of an analytical procedure. It introduces the concept of the lifecycle of a method as a model that can be used to organize the selection, development, validation and routine application of a method. It underlines the importance of method validation, and presents a recent approach based on the accuracy profile to illustrate how validation must be fully integrated into the basic design of the method. Thanks to the β-expectation tolerance interval introduced by Mee (Technometrics (1984) 26(3):251–253), it is possible to unambiguously demonstrate the fitness for purpose of a new method. Remembering that it is also a requirement for accredited laboratories to express the measurement uncertainty, the authors show that uncertainty can be easily related to the trueness and precision of the data collected when building the method accuracy profile.