The role of and the place of method validation in the quality assurance and quality control (QA/QC) system

被引:57
作者
Konieczka, Piotr [1 ]
机构
[1] Gdansk Univ Technol, Fac Chem, Dept Analyt Chem, PL-80952 Gdansk, Poland
关键词
quality control; quality assurance; method validation; validation parameters; uncertainty; traceability; reference material; interlaboratory comparison; GASEOUS STANDARD MIXTURES; MODIFIED SILICA-GEL; THERMAL-DECOMPOSITION; ANALYTICAL-CHEMISTRY; CORRELATION-COEFFICIENT; SURFACE-COMPOUNDS; CHEMICAL MEASUREMENTS; IMMOBILIZED COMPOUNDS; SOLVENT RESIDUES; EDIBLE OILS;
D O I
10.1080/10408340701244649
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
One of the main developmental trends in chemical analytics is the determination of analytes at ever decreasing detection levels in samples with increasingly complex matrices. This is an extremely difficult and complicated task therefore it poses a great challenge to analytical chemists, and it requires that appropriate attention be paid to the Quality Assurance and Quality Control (QA/QC) of the obtained measurements. In this article QA/QC system is described. Following topics are discussed: (1) measurement uncertainty, (2) traceability of analytical results, (3) reference materials, (4) interlaboratory comparisons and (5) method validation. The problems and challenges during method validation process are presented.
引用
收藏
页码:173 / 190
页数:18
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