SPDS 09052014

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5. System suitability tests and/or analytical quality control:

The controls listed in Annex I shall be embedded in assays as appropriate. Interference controls

shall be used for method verification for each new matrix.

6. Reference Material(s):

Refer to Annex F: Development and Use of In-House Reference Materials in Appendix F : Guidelines for Standard Method Performance Requirements ; 19 th Edition of the AOAC

INTERNATIONAL Official Methods of Analysis (2012). Available at:

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

7. Validation Guidance :

All target compounds in Annex II and all matrixes in Annex III shall be evaluated.

Appendix D : Guidelines for Collaborative Study Procedures To Validate Characteristics of a Method of Analysis ; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis

(2012). Available at: http://www.eoma.aoac.org/app_d.pdf

Appendix K : Guidelines for Dietary Supplements and Botanicals; 19 th Edition of the AOAC

INTERNATIONAL Official Methods of Analysis (2012). Available on line at: http://www.eoma.aoac.org/app_k.pdf

Appendix N : ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods; 19 th Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at

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

European Commission Decision 2002/657/EC of 12 August 2002 implementing Council Directive 96/23/EC concerning the performance of analytical methods and the interpretation of results. Available on line at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?

uri=OJ:L:2002:221:0008:0036:EN:PDF

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8. Maximum Time-To-Result:

No maximum time.