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S-Matrix Corporation
1594 Myrtle Avenue
Eureka, CA 95501
USA
Phone: 707-441-0404
URL: www.smatrix.com
Citrix-Ready
Certified
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Certified
Presentation Outline
FMV
FMV
ICH Q2(R1)
The objective of validation of an analytical procedure is to
demonstrate that it is suitable for its intended purpose. A tabular
summation of the characteristics applicable to identification, control of
impurities and assay procedures is included.
Method Validation is a regulatory requirement as much as a scientific
necessity. A well executed method validation effort:
provides scientific credence for the method.
(statistical confidence in the data)
defines the limit of acceptable performance of the method.
(Low and high limits of identification and quantitation)
Accuracy
Linearity and Range
LOQ, LOD
Repeatability* (intra-assay precision)
Accuracy/Linearity and Range/Repeatability Combined Design
(ICH-Q2(R1) Accuracy, Linearity, and Repeatability can be done together as
a single combined experiment).
Sample Solution Stability (stability for a given time period under prescribed
conditions)
Intermediate Precision and Reproducibility (USP Ruggedness)
Robustness
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FMV
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Supported Environments
Standalone (Workstation)
Workgroup
Network
Citrix Metaframe & XenApp
Fully Qualifiable for GxP *
FMV
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FMV
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21 CFR 11 Support
User Management
Role Assignments
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21 CFR 11 Support
Roles Management
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21 CFR 11 Support
Instrument Management
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21 CFR 11 Support
Auditing
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21 CFR 11 Support
Access Management
Administration user
application suspend mode.
Administration global
default password
settings.
Administration
company logo image for
report headers.
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FMV
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Step 3
Chromatography Data Software (CDS)
Generates QbD-aligned
DOE Experiment
Automatically Builds
Sequence and All
Instrument Methods
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Step 4
Automatically Retrieve All
Chromatogram Results Da
Step 5
Automated analysis,
graphing, and reporting.
Report formats:
RTF, DOC, HTML, PDF,
XLSX, XML
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FMV
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ICH Q2(R1).
III. LINEARITY
correlation coefficient
y-intercept
slope of the regression line
residual sum of squares
plot of the data
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ICH Q2(R1):
For chromatographic
procedures,
representative
chromatograms should
be used to
demonstrate specificity,
and individual
components should be
appropriately labeled.
If DL is determined
based on visual
evaluation or based on
signal-to-noise
ratio, the presentation of
the relevant
chromatograms is
considered acceptable
for justification.
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Reports can be
augmented with
images of relevant
chromatograms.
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Reports meet
all output format
requirements:
.TXT
.RTF
.DOC
.PDF
.HTML
.XML
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FMV
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ICH Q2 Robustness
ICH Q2(R1):
The robustness of an analytical procedure is a measure of its capacity to remain
unaffected by small, but deliberate variations in method parameters and
provides an indication of its reliability during normal usage.
In the case of liquid chromatography, examples of typical variations are:
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Method Robustness
1.
2.
3.
1.
2.
3.
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Method Robustness
1.
1.
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Response
-3
L1
+3
L2
L3
Study Factor
Copyright 2016 S-Matrix Corporation. All Rights Reserved.
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Response
-3
+3
>12
L1
L2
L3
L4
L5
Study Factor
Copyright 2016 S-Matrix Corporation. All Rights Reserved.
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Response
-3
+3
>24
L1
L2
L3
L4
L5
Study Factor
Copyright 2016 S-Matrix Corporation. All Rights Reserved.
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Factor
Method
Nominal
1.0
Traditional
Range*
0.025
QbD-aligned
Range
0.125
80.0
2.0
5.0
Temperature (C)
35.0
2.0
10.0
pH (*)
5.5
0.15
0.5
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Method Robustness
2.
2.
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II.
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Method Robustness
3.
3.
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FMVRobustness Summary
1.
2.
3.
1.
2.
3.
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Wrap Up
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End of Presentation
S-Matrix Corporation
1594 Myrtle Avenue
Eureka, CA 95501
USA
Phone: 707-441-0404
URL: www.smatrix.com
Copyright 2016 S-Matrix Corporation. All Rights Reserved.
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