OMB Winter Mtg.-February 5-6, 2015

161

Draft 6. Note: This document is a draft suggestion only and is not an approved document. Please do not distribute to laboratory staff for use. matter of good practice in the laboratory, and shall conform to all applicable environmental or health and safety regulations. In the absence of specific guidance or regulation, proper disposal of materials shall be implemented to protect the environment and society. Optimally, all experiments and test procedures should include not only the in-use procedures but also the safe disposal of all waste materials. 2. Normative References A list of useful references is provided on the AOAC Web site ( www.aoac.org ) in the Publications and Resources section. This approach was chosen to ensure that the most current references are specified. 3. Terms and Definitions 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. Terms and Definitions Bibliography Please note that the current version applies for the references in this document. ( 1 ) JCGM 200, International vocabulary of metrology—Basic and general concepts and associated terms (VIM), Vocabulaire international de métrologie—Concepts fondamentaux et généraux et termes associés (VIM), ©JCGM 2008, http:/www.bipm.org/en/publications/guides/vim.html [This 3rd edition cancels and replaces the 2nd edition, 1993. This 3rd edition is also published as ISO Guide 99 by ISO (ISO/IEC Guide 99 International Vocabulary of Metrology—Basic and General Concepts and Associated Terms, VIM).]. ( 2 ) Conformity assessment—Vocabulary and general principles. ISO/IEC 17000. ( 3 ) Quality management systems—Fundamentals and vocabulary. ISO 9000. ( 4 ) Terms and definitions used in connection with reference materials. ISO Guide 30. ( 5 ) Revision of definitions for reference material and certified reference material. ISO Guide 30. ( 6 ) Standardization and related activities—General vocabulary. ISO Guide 2. ( 7 ) United States Pharmacopoeia and National Formulary (USP/NF) http://www.uspnf.com/uspnf/login ( 8 ) European Pharmacopoeia, http://online6.edqm.eu/ep603/ ( 9 ) International Committee of Harmonization (ICH) Q2 (R1): Validation of Analytical Procedures: Text and Methodology, http://www.ich.org ( 10 ) Official Methods of Analysis of AOAC INTERNATIONAL , http://eoma.aoac.org/ (11) United States Code of Federal Regulations 21 CFR 210, 211, and 111 4. Management Requirements 4.1 Organization