1.0 Purpose : To lay down a procedure for Analytical Method Validation.
2.0 Objective : To provide documented procedure for Analytical Method Validation.
3.0 Scope : To define role/responsibility of various persons responsible for Analytical Method Validation.
4.0 Responsibility :
· Primary : Officer QA/ QC
· Secondary : Manager QA/ QC
5.0 Procedure :
· General Concepts
Ø Validation is the act of demonstrating and documenting a procedure that operates effectively.
Ø The discussion of the validation of analytical procedures is directed to the four most common types of analytical procedure:
R Identification tests
R Quantitative tests for impurities content
R Limit tests for the control of impurities
R Quantitative tests of the active moiety in samples of drug substance or drug product or other selected components in the drug product.
Ø Typical validation characteristics which…
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