2014 ERP New Member Book

G UIDELINES FOR S TANDARD M ETHOD P ERFORMANCE R EQUIREMENTS

AOACO FFICIAL M ETHODS OF A NALYSIS (2012)

Appendix F, p. 4

Table 2. Exampleofmethodperformance table formultiple analytes Analyte 1

Analyte 2

Analyte 3

Analytical range

10–20μg/mL

100–200μg/mL

200–500μg/mL

Limit of quantitation (LOQ)

 10μg/mL

 100μg/mL

 200μg/mL

Repeatability (RSD r )

<10μg/mL  10μg/mL

<10μg/mL  10μg/mL

<200μg/mL  200μg/mL

 8%  6%

 8%  6%

 10%

 8%

For projectswithmultiple analytes, for example, vitaminsA, D, E, andK in infant formula, it may be useful to organize a separate working group to fully describe the matrix(es) so that a common description of thematrix(es) can be applied to all of the analytes. For single analyte SMPRs, it is most common to organize the method performance requirements into a table with 2–3 columns as illustrated in Table 1. For multiple analyte SMPRs, it is often convenient to present the requirements in an expanded table with analytes forming additional columns as illustrated inTable 2. Once the intended use, analytical techniques, and method performance requirements have been determined, then a working group can proceed to consider the quality control parameters, such as the minimum validation requirements, system suitability procedures, and reference materials (if available). It is not uncommon that an appropriate referencematerial is not available. AnnexF of theSMPRGuidelinesprovidescomprehensiveguidance for the development and use of in-house referencematerials. Most working groups are able to prepare a consensus SMPR in about 3months. OpenComment Period Once a working group has produced a draft standard, AOAC opens a comment period for the standard. The comment period provides an opportunity for other stakeholders to state their perspective on the draft SMPR. All collected comments are reviewed by theAOACCSO and theworking group chair, and the comments are reconciled. If there are significant changes required to thedraft standardas a result of thecomments, theworkinggroup is convened to discuss and any unresolved issueswill be presented for discussion at the stakeholder panelmeeting. Submissionof Draft SMPRs to theStakeholder Panel Stakeholderpanelsmeet several timesayearatvarious locations. Theworkinggroupchair (ordesignee)presentsadraftSMPR to the stakeholderpanel for reviewanddiscussion.Aworkinggroupchair is expected to be able to explain the conclusions of the working group, discuss comments received, and to answer questions from the stakeholder panel. Themembers of the stakeholder panel may revise, amend, approve, or defer adecisionon theproposedSMPR. Asupermajorityof 2/3ormoreof thosevoting is required to adopt anSMPR as anAOAC voluntary consensus standard. Publication Adopted SMPRs are prepared for publication byAOAC staff, andarepublished in the Journal ofAOAC INTERNATIONAL and in theAOAC OfficialMethods of Analysis SM compendium. Often, the AOACCSO andworking group chair prepare a companion article to introduceanSMPRanddescribe theanalytical issues considered and resolved by the SMPR.An SMPR is usually publishedwithin 6months of adoption.

Conclusion SMPRs are a unique and novel concept for the analytical methods community. SMPRs are voluntary, consensus standards developed by stakeholders that prescribe the minimum analytical performance requirements for classes of analytical methods. The SMPR Guidelines provide a structure for working groups to use as they develop an SMPR. The guidelines have been employed in severalAOACprojects andhavebeenproven tobeveryuseful. The guidelines are not a statute that users must conform to; they are a “living” document that is regularly updated, so users should check theAOACwebsite for the latest versionbeforeusing theguidelines. References (1) Eurachem, TheFitness forPurpose of AnalyticalMethods: ALaboratoryGuide toMethodValidation andRelated Topics, Validation , http://www.eurachem.org/guides/pdf/ valid.pdf, postedDecember 1998, accessedMarch 2012 (2) Guidelines forCollaborative StudyProcedures to ValidateCharacteristics of aMethod of Analysis (2012) OfficialMethods of Analysis, AppendixD ,AOAC INTERNATIONAL, Gaithersburg,MD (3) AOAC INTERNATIONALMethodsCommitteeGuidelines forValidation of Biological Threat AgentMethods and/ orProcedures (2012) OfficialMethods of Analysis, 19th Ed., Appendix I, Calculation of CPOD and dCPODValues fromQualitativeMethodCollaborative StudyData ,AOAC INTERNATIONAL, Gaithersburg,MD (4) AOACGuidelines for Single-LaboratoryValidation of ChemicalMethods forDietary Supplements andBotanicals (2012) OfficialMethods of Analysis , 19thEd., AppendixK , AOAC INTERNATIONAL, Gaithersburg,MD (5) CodexAlimentariusCodexProcedureManual (6) InternationalOrganization for Standardization, Geneva, Switzlerland

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