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OMB MEETING MATERIALS

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Straw Man: This document is a starting point for future drafts and is not an approved document. Please do not distribute to laboratory staff for use.

Bibliography

The following bibliography for definitions may be used to find the recent definition from authoritative sources. Some definitions are not directly applicable to laboratories and some terms have multiple definitions. The laboratory should review the definitions and select the one that is most applicable to its use. In addition, a list of terms and definitions not found in the authoritative sources is provided on the AOAC Web site ( www.aoac.org ) in the Accreditation Section. This approach was chosen to ensure that the most current internationally harmonized definitions and terms are specified.

Please note that the current version applies for the references in this document.

( 1 ) Conformity assessment—Vocabulary and general principles. ISO/IEC 17000.

( 2 ) Standardization and related activities—General vocabulary. ISO Guide 2.

( 3 ) United States Pharmacopoeia and National Formulary (USP/NF) http://www.uspnf.com/uspnf/login

( 4 ) European Pharmacopoeia, http://online6.edqm.eu/ep603/

( 5 ) International Committee of Harmonization (ICH) Q2 (R1): Validation of Analytical Procedures: Text and Methodology, http://www.ich.org

( 6 ) Official Methods of Analysis of AOAC INTERNATIONAL , http://eoma.aoac.org/

(7) United States Code of Federal Regulations 21 CFR 11, 111, 210, and 211

08/09/2018