History of reference materials for food and nutrition metrology: as represented in the series of BERM symposia

Wolf, Wayne R.

doi:10.1007/s00216-009-3363-y

Cited by 7 publications

(1 citation statement)

References 94 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The consultation recommended that full validation should be conducted for selected analytes representative of the analytes included in the method and for matrices typical of the sample materials received routinely for analysis. Selection of representative analytes would be based, in large measure, on the expectation that those analytes were most likely to be encountered in typical samples, while representative matrices would be chosen from commonly received sample materials, based on the food triangle approach . Thus, a leaf lettuce might be chosen to represent green, leafy vegetables and an orange might be chosen to represent citrus fruit.…”

Section: Introductionmentioning

confidence: 99%

Analytical difficulties facing today's regulatory laboratories: issues in method validation

MacNeil

2012

Drug Testing and Analysis

View full text Add to dashboard Cite

The challenges facing analytical laboratories today are not unlike those faced in the past, although both the degree of complexity and the rate of change have increased. Challenges such as development and maintenance of expertise, maintenance and up-dating of equipment, and the introduction of new test methods have always been familiar themes for analytical laboratories, but international guidelines for laboratories involved in the import and export testing of food require management of such changes in a context which includes quality assurance, accreditation, and method validation considerations. Decisions as to when a change in a method requires re-validation of the method or on the design of a validation scheme for a complex multi-residue method require a well-considered strategy, based on a current knowledge of international guidance documents and regulatory requirements, as well the laboratory's quality system requirements. Validation demonstrates that a method is 'fit for purpose', so the requirement for validation should be assessed in terms of the intended use of a method and, in the case of change or modification of a method, whether that change or modification may affect a previously validated performance characteristic. In general, method validation involves method scope, calibration-related parameters, method precision, and recovery. Any method change which may affect method scope or any performance parameters will require re-validation. Some typical situations involving change in methods are discussed and a decision process proposed for selection of appropriate validation measures.

show abstract

Section: Introductionmentioning

confidence: 99%