Method Validation Sop

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Document #: QA/SOP/001-A SOP for Analytical Method Validation

Revision No: 00Issue No:02

For internal use only.

Do not duplicate.

PURPOSE:To provide guidelines for the validation of non-standard or modified methods for

laboratory analysis.

SCOPE:This procedure is applicable to the analysis of samples using methodologies that are not

established by the USP, BP, EP, JP, P or any other Pharmacopoeia.

RESPONSIBILITY:

The !uality "ssurance #anager is responsible for determining the level of validation

re$uired for each analytical method.

Each analyst is responsible for generation of data by the specific instructions of the

!uality "ssurance #anager%!uality &ontrol #anager

The analyst is also responsible for the initial revie' of the data pac(age.

The !uality "ssurance #anager%!uality &ontrol #anager is responsible for secondary

revie' of the data pac(age to assure that the analytical methodology used is validated

by the instruction of this S)P.

PROCEDURE:

Prior to initiating a validation study, the pre-validation activities and subse$uent development

report should be completely covered in the Specific method validation protocol. The method

validation protocol outline is as follo's*

+. TTE ) #ET)/

a. "uthor0s 1ame and Title

b. /epartment

c. Signature and /ate

2. "PP3)4"S

a. 1ames and Titles

b. /epartment

c. Signature and /ate

5. S&)PE ) #ET)/

6rite the ob7ective8 a simple statement of 'hat the protocol 'ill accomplish

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9. 4"/"T)1 P"3"#ETE3S

The actual parameters 'ill be comprised from a subset of the belo' list based on the intended

use of the method. Each re$uirement selected for in a given validation protocol should be

follo'ed 'ith detailed strategy 'hich 'ill be used to test for the parameter including the format

of data tables, sampling scheme, sample si:e and formulas for intended calculations.

a. Specificity

b. inearity

c. Precision

d. "ccuracy

e. 3uggedness

;. E!UP#E1T

This section should provide all information for the use of the e$uipment or other apparatus

necessary to conduct all aspects of the method.

'here necessary?.

>e.g. ra' materials, in-process materials, finished goods or stability samples?

A. P3)&E/U3E

This section should contain all information applicable and relative to the sample, standard and

blan( preparation >etraction, dilution etc?, instrument parameters, determination and

calculations

a. Sample preparation

i. Etraction

ii. /ilution

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iii. )ther

b. Standard Preparation

i. Etraction

ii. /ilution

iii. )ther

c. Blan( Preparation

d. nstrument )perating Parameters

i. nstruments

ii. )perating conditions

+. &olumns

2. Temperature

5. 6avelength

9. Special &alibration

;. )ther

iii. /eterminative step

iv. &alculations >all dilution factors and calculation parameters should be clearly

eplained?

C. E4"U"T)1 &3TE3"

Specifications or specific values establishing acceptance criteria for each validation parameter

tested for.

+D. 3EE3E1&ES

4"/"T)1 SU##"3 3EP)3T

Subse$uent to the eecution of the protocol, the data must be analy:ed 'ith results, conclusions and

deviations presented in an official validation summary report. The method can be considered valid

provided that all pre-defined acceptance criteria is met and the deviation >if any? do not affect the

scientific interpretation of the data. " statement of the methods validation status should be placed at

the beginning of the final validation summary report, along 'ith signatures, dates and titles of all the

participants and revie'ers.

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Method Validation Sop