67
5.
System
suitability tests and/or analytical quality control:
68
The controls listed in Annex I shall be embedded in assays as appropriate. Interference controls
69
shall be used for method verification for each new matrix.
70
71
6.
Reference Material(s):
72
Refer to Annex F:
Development and Use of In-House Reference Materials
i
73
Guidelines for Standard Method Performance Requirements
; 19
th
Edition of the AOAC
74
INTERNATIONAL Official Methods of Analysis (2012). Available at:
75
76
77
7.
Validation Guidance
:
78
79
All target compounds in Annex II and all matrixes in Annex III shall be evaluated.
80
81
Guidelines for Collaborative Study Procedures To Validate Characteristics of a
82
Method of Analysis
;
19
th
Edition of the AOAC INTERNATIONAL Official Methods of Analysis
83
(2012). Available at:
84
85
Guidelines for Dietary Supplements and Botanicals; 19
th
Edition of the AOAC
86
INTERNATIONAL Official Methods of Analysis (2012).
87
Available on line at:
88
89
ISPAM Guidelines for Validation of Qualitative Binary Chemistry Methods; 19
th
90
Edition of the AOAC INTERNATIONAL Official Methods of Analysis (2012). Available at
91
92
93
European Commission Decision 2002/657/EC of 12 August 2002 implementing Council
94
Directive 96/23/EC concerning the performance of analytical methods and the interpretation
95
of results. Available on line at:
?
96
uri=OJ:L:2002:221:0008:0036:EN:PDF
97
98
99
8.
Maximum Time-To-Result:
100
No maximum time.
101
102
