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Analytical difficulties facing today's regulatory laboratories: issues in method validation
Author(s) -
MacNeil James D.
Publication year - 2012
Publication title -
drug testing and analysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.065
H-Index - 54
eISSN - 1942-7611
pISSN - 1942-7603
DOI - 10.1002/dta.1358
Subject(s) - scope (computer science) , accreditation , risk analysis (engineering) , computer science , quality assurance , context (archaeology) , process (computing) , quality (philosophy) , traceability , management science , process management , operations research , reliability engineering , systems engineering , engineering , operations management , software engineering , business , paleontology , philosophy , external quality assessment , epistemology , economics , biology , programming language , economic growth , operating system
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.