ASTM_E_2549_-_14.pdf

Designation:E254914Standard Practice forValidation of Seized-Drug Analytical Methods1This standard is issued under the fixed designation E2549;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice addresses the validation of qualitative andquantitative seized-drug analytical methods.It discusses thevalidation of analytical methods in terms of their part inanalytical schemes and in terms of performance characteristicsincluding brief mention of measurement uncertainty and qual-ity control parameters.1.2 This practice does not replace knowledge,skill,ability,experience,education or training and should be used inconjunction with professional judgment.1.3 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E2327 Practice for Quality Assurance of Laboratories Per-forming Seized-Drug AnalysisE2764 Practice for UncertaintyAssessment in the Context ofSeized-Drug Analysis3.Significance and Use3.1 Validation is the confirmation by examination and theprovision of objective evidence that the particular requirementsfor a specific intended use are fulfilled.There are numerousdocuments that address the topic of validation but there are fewvalidation protocols for methods specific to seized drug analy-sis.This practice makes recommendations for the validation ofboth qualitative and quantitative methods used for the analysisof seized drugs.4.Analytical Scheme4.1 An analytical scheme shall be comprised of validatedmethods that are appropriate for the analyte.4.2 The combinations of methods chosen for a particularanalytical scheme shall identify the specific drug of interest,preclude a false positive and minimize false negatives.4.3 For quantification the method should reliably determinethe amount of analyte present.4.4 If validated methods are used from published literatureor another laboratorys protocols,then the methods shall beverified within each laboratory4.5If non-routine validated methods are used,then themethod shall be verified prior to use.4.6 Verification should,at a minimum,demonstrate that arepresentative set of reference materials has been carriedthrough the process and yielded the expected results.5.Individual Laboratory Responsibility5.1 Each laboratory should determine whether their currentstandard operating procedures have been validated,verified,orrequire further validation/verification.6.Operational Environment6.1 All methods shall be validated or verified to demonstratethat they will perform in the normal operational environmentwhen used by individuals expected to utilize the methods oncasework.7.Documentation7.1 The entire validation/verification process shall be docu-mented and the documentation shall be retained for a period inaccordance with laboratory policy.Documentation shallinclude,but is not limited to the following:7.1.1 Personnel involved;7.1.2 Dates;7.1.3 Observations from the process;7.1.4 Analytical data;7.1.5 A statement of conclusions or recommendations,orboth;and7.1.6 Authorization approval signature.1This practice is under the jurisdiction of ASTM Committee E30 on ForensicSciences and is the direct responsibility of Subcommittee E30.01 on Criminalistics.Current edition approved March 1,2014.Published March 2014.Originallyapproved in 2009.Last previous edition approved in 2009 as E2549 09.DOI:10.1520/E2549-14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 8.Recommendation8.1 To meet the requirements of Sections 4 through 7,it isrecommended that laboratories follow the applicable provi-sions of Section 9 General Validation Plan when validatingseized-drug analytical methods.NOTE1For further information,see http:/www.swgdrug.org forSupplemental Documents SD-2“Preparing Validation Plans,Section I:Analytical Techniques Elements to Consider”and Section II:“ExampleValidation Plan for GC/MS Identification and Quantitation of Heroin,”SWGDRUG.9.General Validation Plan9.1 Purpose/ScopeThis is an introductory statement thatwill specify what is being tested,the purpose of the testing andthe result(s)required for acceptance.9.1.1 Performance SpecificationA list of specific objec-tives(for example,trueness and precision)should be deter-mined prior to the validation process.9.1.2 Process Rev