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�RIAi VALIDATION OF TEST METHODS CAR.SOP.19

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STANDARD OPERATING PROCEDURE

FOR THE

VALIDATION OF TEST METHODS

Authorised by: Chief Executive Officer

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DOCUMENT CHANGE HISTORY

Date of
Pg # Section Comment/Reason for Change Brief Description of Change
Change

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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

This procedure covers all non-standard methods, laboratory-designed / developed

methods, standard methods used outside their intended scope and amplifications and
modifications of standard methods.

3.0 RESPONSIBILITIES

3.1 The Laboratory Manager for the respective laboratory is responsible for:

• Designating competent staff to plan, conductand document the validation exercise.

• 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.

• Reviewing the planning and conduct of the validation exercise at appropriate

stages.

4.0 REFERENCES

4.1 ISO/IEC 17025:2005 -5.4.5 Validation of Methods

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.

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5.2 Method Validation refers to the process of establishing the performance

characteristics and limitations of a method and the identification of the influences
which may change these characteristics and to what extent.

6.0 PROCEDURE

6.1 Input

Non-Standard Analytical Method

6.2 Output

Validated or Revalidated Analytical Method

6.3 Process Steps

1. All non-standard analytical methods are validated or revalidated:-

• Before their introduction into routine use;
• Whenever the conditions change for which the method has been validated (e.g.
an instrument with different characteristics or samples with a different matrix);

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.

• Type of compounds and matrix.

• All chemicals, reagents, reference standards, QC samples with purity, grade,

their source or detailed instructions on their preparation.

• Procedures for quality checks of standards and chemicals used.

• Safety precautions.

• A p lan and procedure for method implementation from the method

development to routine analysis.

• Method parameters.

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• Critical parameters taken from robustness testing.

• 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.

• Detailed conditions on how the experiments were conducted, including sample

preparation. T he report must be detailed enough to ensure that it can be
reproduced by a competent technician with comparable equipment.

• Statistical procedures and representative calculations .

• Procedures for QC in routine analyses, e.g. system suitability tests.

• Representative plots, e.g. chromatograms, spectra and calibration curves.

• Method acceptance limit perfo rmance data.

• The expected uncertainty of measurement results.

• Criteria for revalidation.

• The person(s) who developed and validated the method.

• References (if any).

• Summary, conclusions and recommendation as to fitness for intended purpose

and revalidation schedule.

• 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 .

4. Documentation on the method validation is kept in the relevant laboratory as long

as the test is routinely performed.

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7.0 RELATED DOCUMENTED INFORMATION

7.1 Va lidation Reportand any other related documentation.

8.0 APPENDICES

None

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