AOAC Conformity Assessment

Protocol Development – Consulting Service

Benefits of using the Consulting

Service:

Understanding for both sides

–

AOAC has better understanding of

the method and claims

–

Method Developer has better

understanding of AOAC

requirements

Can significantly reduce Method Developer

time and cost

Use of most current technical guidance,

updates and requirements

Permits parallel independent testing

Deliverables to Method Developer is a full

validation outline that includes:

•

Discussion of testing procedures and

acceptance criteria

•

Discussion of areas of potential difficulties

•

Validation flowcharts

•

Validation study report/manuscript

template

•

Approved method validation protocols for

single laboratory and independent

laboratory validation studies

•

Approved by the AOAC Expert

AOAC Website lists Method Validation Guidelines and References for Technical Requirements

http://www.aoac.org/vmeth/guidelines.htm

Guidelines for Collaborative Study Procedures to Validate Characteristics of a Method of Analysis (OMA, Appendix

D) - J. AOAC INTERNATIONAL. 78, 143A-160A (1995) (Harmonized with IUPAC and CODEX)

http://www.aoac.org/Official_Methods/Collaborative_Study_Validation_Guidelines.pdf

AOAC® Guidelines for Validation of Microbiological

Methods for Food and Environmental Surfaces (Appendix J in

electronic version of OMA)

http://www.eoma.aoac.org/app_j.pdf

AOAC INTERNATIONAL Methods Committee Guidelines for Validation of Biological Threat Agent Methods and/or

Procedures (OMA, Appendix F) - J. AOAC INTERNATIONAL, 94, 1359-1381 (2011)

http://www.eoma.aoac.org/app_f.pdf

AOAC Guidelines for Dietary Supplements and Botanicals (Appendix K in electronic version of OMA)

http://www.eoma.aoac.org/app_k.pdf .

Policy on Characterization of Antibodies Used in Immunochemical

Methods of Analysis for Mycotoxins and

Phycotoxins - J. AOAC INTERNATIONAL, 86, 868-871 (2003)

http://www.aoac.org/Official_Methods/Mycotoxins.pdf

IUPAC: Harmonized Guidelines for Single Laboratory Validation of Methods of Analysis - Pure Appl. Chem., 74,

835–855 (2002)

AOAC INTERNATIONAL Recommended Guidelines For SPIFAN Single Laboratory Validation (SLV) (Appendix L in 19

ed. OMA) -

http://www.eoma.aoac.org/app_l.pdf .

ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods (Appendix N in electronic version of

OMA)

http://www.eoma.aoac.org/app_n.pdf .

OMA APPENDICES & RESOURCES

Not an all inclusive listing. Visit eOMA and click on Appendices for more information.