DOC NO.

: KCI/P18

Procedure for Method Validation Rev No. : 00

Date : 10.06.2024

1. Purpose.....................................................................................................................................2
2. Scope........................................................................................................................................2
3. Responsibility............................................................................................................................2
4. Background...............................................................................................................................3
5. References................................................................................................................................4
6. Procedure..................................................................................................................................5
6.1. Method Selection............................................................................................................5
6.2. Method Evaluation& Record...........................................................................................5
6.3. Standard Method Verification.........................................................................................5
6.3.1. Chemistry.........................................................................................................6
6.3.2. Microbiology.....................................................................................................8
6.3.3. Other Scientific Disciplines...............................................................................8
6.4. Validation of Method Performance.................................................................................8
6.5. Validation of Method Modifications.................................................................................9
6.6. Validation Tools............................................................................................................10
6.7. Validation Protocol Guidance.......................................................................................10
6.7.1. General...........................................................................................................10
6.7.2. Chemistry.......................................................................................................11
6.7.3. Microbiology...................................................................................................12
6.7.4. Other Scientific Disciplines.............................................................................12
6.8. Documentation.............................................................................................................12
6.8.1. Method Verification.........................................................................................12
6.8.2. Method Validation...........................................................................................13
7. Glossary/Definitions................................................................................................................14
8. Records...................................................................................................................................16
9. Supporting Documents............................................................................................................16
10. Documents History…………………………………………………………………………………...17
11. Change History.......................................................................................................................17
12. Attachments............................................................................................................................17

Technical Manager Quality Manager CEO of the Laboratory

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 DOC NO. : KCI/P18

Procedure for Method Validation Rev No. : 00

Date : 10.06.2024

1. Purpose

This procedure provides basic requirements to Kwality Cable India (KCI) Laboratories for
development, validation, and verification of method performance specifications for new methods,
modified methods or procedures previously validated externally.

2. Scope

KCI Laboratories Verify standard method performances and validate new or modified methods
introduced into the laboratory.
Assuring the Quality of Test Results for continuing verification of acceptable performance of
each Lot through a Quality Control Program.
3. Responsibility

A. The Laboratory Supervisor or Quality Manager ensures the following, in consultation

with the laboratory staff as needed:

i. Development of methods is a planned activity and assigned to qualified staff with

Appropriate resources.
ii. For larger projects, plans are updated as progress is made and effectively
communicated to all personnel.
iii. Ensure the report for the test or calibration is compliant with standard requirements
and customer needs.
B. The Technical Manager reviews the documented procedure, data, and
analysis, and recommends final acceptance to the Laboratory Manager or
Quality Manager based on the suitability of the procedure and acceptability of
observed analysis of measurement results.

C. The Laboratory Supervisor or Quality Manager is responsible for final

acceptance of new calibration methods, training staff on the new procedure,
and for consistent implementation.

4. Background
As a regulatory agency, it is imperative that the analytical methods KCI laboratories employ for
surveillance, compliance and outbreak investigations continue to meet the highest standard of
review and performance.

Technical Manager Quality Manager CEO of the Laboratory

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 DOC NO. : KCI/P18

Procedure for Method Validation Rev No. : 00

Date : 10.06.2024

When a standard analytical method is verified, the laboratory is required to demonstrate with
objective evidence that it can achieve specified performance characteristics/ parameters proven
during the initial validation study. The validation study must establish pertinent performance
characteristics (e.g., accuracy, precision, sensitivity, limit of detection, etc.) that demonstrate or
confirm a method is suitable for its intended purpose. Any significant modification to existing
procedures involving a major change in part of the original process that will affect the instruments
and/or samples used to produce data must be validated.

5. References

ISO/IEC 17025:2017 General requirements for the competence of testing and

calibration laboratories.

6. Procedures

Method Validation

A. Non-standardized methods, which include all laboratory developed methods,

standardized methods modified beyond their intended scope and
amplifications and modifications of standardized methods, are validated by:
i. Examination to ensure completeness and compliance with requirements for
essential components of metrological traceability; and
ii. Analysis of objective evidence to ensure the requirements for a specific intended
purpose are fulfilled prior to use.

B. Validation methods are to be as extensive as necessary to meet the needs of

their intended application. Adequate measurement data is obtained to ensure
statistical validity of the evaluated results. The accuracy and uncertainty of test or
calibration results shall be assessed for the intended use, and shall be relevant to
the client’s needs.
C. Validation procedures and results are recorded, with a statement concerning
the appropriateness of the new method as it pertains to the intended use.

D. Validation techniques include one or a combination of the following:

i. Calibration/verification and evaluation of bias and precision using
calibrated working standards;
ii. Comparison of results achieved with other standardized methods;
iii. Method evaluation through variations of controlled parameters (e.g., one

Technical Manager Quality Manager CEO of the Laboratory

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 DOC NO. : KCI/P18

Procedure for Method Validation Rev No. : 00

Date : 10.06.2024

variable at a time) to determine robustness;

iv. Inter-laboratory comparisons when practical;
v. Systematic assessment of factors influencing the results; and

vi. Evaluation of the uncertainty of results based on scientific understanding of

the theoretical principles associated with the method and practical
experience.

E. When changes are made in the validated non-standardized procedures, the

influence of such changes must be documented and, if appropriate, a new
validation process carried out.

F. The following types of assessments, with data and statistical analysis are
examples that may be used to assess the measurement results (See Appendix A
form):
i. Inspection and technical assessment of the essential elements of
metrological traceability to ensure presence and adequacy (technical
review may include representatives from other laboratories, working
groups, technical experts, and assessors):
1. Reference to the international system of units(SI);
2. Unbroken chain of calibrations to national and/or international standards;
3. Suitable and up to date calibration intervals for standards used in the
procedure;
4. Documented procedure (reviewed to ensure completeness against the list
of items in Section4.d.);
5. Documented measurement uncertainty (as noted in Section 4.d.v.);
6. Demonstrated technical competence;
7. Adequate measurement assurance approach and supporting data.
ii. Accuracy or Limits to Bias may use data obtained from internal testing and/or
interlaboratory comparisons: t-test, normalized error (En), absolute or relative
bias versus required tolerance limits;
iii. Precision: standard deviation, normalized precision (P n), F-test, comparison
to required uncertainties (fit for purpose and meeting needs of the customer)

iv. Repeatability: assessment of results over time and by different operators

following the procedure as documented
v. Reproducibility: assessment of data from other laboratories following the
procedure
7. Glossary
None

Technical Manager Quality Manager CEO of the Laboratory

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 DOC NO. : KCI/P18

Procedure for Method Validation Rev No. : 00

Date : 10.06.2024

8. Records
Laboratory records shall be retained for all aspects of the procedure validation for
as long as the procedure remains in valid use, including but not limited to:

 The validation procedure (and version) that issued;

 Any applicable specifications and/or tolerances;
 Evaluation of performance characteristics and summaries;
 Observed data and measurement results;

 Approval for use by the customer ;and

 A statement that the method is valid and suitable for its intended use.

9. Supporting Documents
A. Method Verification
B. Bonton Laboratory Manual, Volume I, KCI Method Development and Validation Program
10. Document History
Revision Status* Approving Official Name
Date Author Name and Title
# (D, I, R) and Title

* - D: Draft, I: Initial, R: Revision

11. Change History

Revision
Change
#

12. Attachments
None

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