Aim and scope of analytical method validation

Aim of Validation

Validation process should establish and provide documentary evidence that :

The premises , the facilities , the equipment and the processes have been designed in accordance with the requirements of current GMP that each pharmaceutical company indentifies what qualification and validation work is required to prove control of the critical aspects of the particular operation .

 Pharmaceutical validation will include the following area

—Analytical test method
—Instrument
—Process utility services
—Raw materials
—Packaging material
—Equipment
—Facilities
—Manufacturing operations
—Product designs
—Cleaning

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 the samples of drug substance or
  drug product or other selected component (s) in the drug product.

• Although there are many other analytical procedures such as , dissolution testing for drug
  products or particle size determination for drug substance these have not been addressed in the initial text on validation of analytical procedures.