Definition:
Method validation
confirms that the analytical procedure employed for a specific test is suitable
for its intended use.
Types of Analytical
Procedures to be Validated
- Identification tests
- Quantitative tests for impurities'
content
- Limit tests for the control of
impurities
· Quantitative
tests of the active moiety in samples of drug substance or drug product or
other selected components in the drug product.
Furthermore revalidation may be necessary in the
following circumstances:
- changes in the synthesis of the drug substance
- changes in the composition of the
finished product
- changes in the analytical procedure
No comments:
Post a Comment