Analytical Method Validation

DRUG REGULATORY AFFAIRS INTERNATIONAL

GDP

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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PHARMA PROFESSIONAL, ITALY
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