Document Detail

Analytical difficulties facing today's regulatory laboratories: issues in method validation.
MedLine Citation:
PMID:  22851356     Owner:  NLM     Status:  In-Data-Review    
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. © 2012 John Wiley & Sons, Ltd.
James D Macneil
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Drug testing and analysis     Volume:  4 Suppl 1     ISSN:  1942-7611     ISO Abbreviation:  Drug Test Anal     Publication Date:  2012 Aug 
Date Detail:
Created Date:  2012-08-01     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101483449     Medline TA:  Drug Test Anal     Country:  England    
Other Details:
Languages:  eng     Pagination:  17-24     Citation Subset:  IM    
Copyright Information:
© 2012 John Wiley & Sons, Ltd.
Department of Chemistry, St Mary's University, Halifax, NS, Canada.,
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