2014 ERP New Member Book

AOACO FFICIAL M ETHODS OF A NALYSIS (2012)

G UIDELINES FOR S TANDARD M ETHOD P ERFORMANCE R EQUIREMENTS Appendix F, p. 5

5. MethodPerformanceRequirements: List the performance parameters and acceptance criteria appropriate for each method/ analyte/matrix. See Table A1 for appropriate performance requirements. Ifmore thanone analyte/matrix, and if acceptance criteria differ for analyte/matrix combinations then organize a table listing each analyte/matrix combination and its minimum acceptance criteria for each performance criteria. 6. System Suitability Tests and/or Analytical Quality Control: Describeminimum system controls andQC procedures. 7. Reference Material(s): Identify the appropriate reference materials if they exist, or state that reference materials are not available. Refer to Annex E ( AOACMethodAccuracy Review ) for instructions on the use of referencematerials in evaluations. 8. Validation Guidance: Recommendations for type of evaluation or validation program such as single-laboratory validation (SLV), Official Methods of Analysis SM (OMA), or PerformanceTestedMethods SM (PTM). 9. Maximum Time-to-Determination: Maximum allowable time to complete an analysis starting from the test portion preparation tofinal determination ormeasurement. Annex I: Inclusivity/Selectivity Panel . Recommended for qualitative and identificationmethodSMPRs. Annex II:Exclusivity/Cross-ReactivityPanel . Recommended for qualitative and identificationmethodSMPRs. Annex III: Environmental Materials Panel . Recommended for qualitative and identificationmethodSMPRs.

ANNEXA Format of a StandardMethodPerformanceRequirement

AOACSMPRYYYY.XXX (YYYY=Year; XXX=sequential identificationnumber) MethodName : Must include the analyte(s), matrix(es), and analytical technique [unless the standardmethod performance requirement (SMPR) is truly intended to be independent of the analytical technology]. Themethod namemay refer to a “common” name (e.g., “Kjeldahl”method). ApprovedBy: Name of stakeholder panel or expert review panel Final VersionDate : Date EffectiveDate: Date 1. IntendedUse: Additional information about themethod and conditions for use. 2. Applicability: List matrixes if more than one. Provide details on matrix such as specific species for biological analytes, or International Union of Pure and Applied Chemistry (IUPAC) nomenclature and Chemical Abstracts Service (CAS) registry number for chemical analytes. Specify the form of thematrix such as raw, cooked, tablets, powders, etc. 3. Analytical Technique: Provide a detailed description of the analytical technique if theSMPR is to apply to a specific analytical technique; or state that theSMPR applies to anymethod thatmeets themethod performance requirements. 4. Definitions: List and define terms used in the performance parameter table ( see TableA2 for list of standard terms).

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