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CAR - SOP.19 - VALIDATION OF TEST METHODS Iss 1 Rev 01 Issue Date May 16 2018
CAR - SOP.19 - VALIDATION OF TEST METHODS Iss 1 Rev 01 Issue Date May 16 2018
FOR THE
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~ RIRI VALIDATION OF TEST METHODS CAR.SOP.19
Date of
Pg # Section Comment/Reason for Change Brief Description of Change
Change
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CARIRI cor~Tf GllcO 0[ CUMtNT
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Issue/ Rev#: 1/0 I Issuc Date: May I6'h 2018 Page 2 of6
DOCUMENT#:
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V ALIDATI ON OF TEST METHODS CAR.SOP.19
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1.0 PURPOSE
To confirm that the analytical procedures employed for specific tests are suitable for
the intended use.
2.0 SCOPE
3.0 RESPONSIBILITIES
3.1 The Laboratory Manager for the respective laboratory is responsible for:
• Giving direction on the adequacy, depth and validity of the plan / exercise,
including the performance characteristics to be evaluated i.e. accuracy, precision,
specificity, detection limit, quantitation limit, linearity, range, robustness.
4.0 REFERENCES
4.2 CARIRI Laboratory Quality Manual Section 7.3: Documentation of Methods and
Procedures
5.0 DEFINITIONS
5.1 Validation refers to the confirmation by examination and the provision of objective
evidence that the particular requirements for a specific intended use are fulfilled.
6.0 PROCEDURE
6.1 Input
6.2 Output
or
• Whenever the method is revised and the change is outside the original scope of
the method.
2. At the end of the exercise a validation report is prepared. The validation report
should include as applicable:
• Summary of methodology.
• Safety precautions.
• Method parameters.
• Listing of equipment and its functional and performance requirements, e.g. cell
dimensions, baseline noise and column temperature range. For complex
equipment, a pi cture or schematic diagram may be useful.
• Approval with names, titles, date and signature o t 1osc responsible for the
review and approval of the analytical test procedure.
3. The method is deemed fit for the intended purpose by the Lab Manager and may
be done expl icitly w ith the words "Authorised as fit for intended use" and a
signature or alternatively it may be impl icitly declared as fit for intended
use,when the Laboratory Manager signs the cover page of a method for which the
validation data sum mary is included in the controlled document for the method .
Iss ue/ Rev# : 1/0 1 Issue Date: May I6'h 20 I 8 Page 5 of6
DOCUM ENT#:
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VALIDATION OF TEST METHODS CAR.SOP.19
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8.0 APPENDICES
None