Analytical Methods Transfer

The validation of analytical test methods is a critical element supporting drug development, NDA/ANDA submissions and drug product production control. Methods validation has been the subject of many FDA 483 observations, and the FDA has identified methods validation as one of the significant compliance issues. Companies involved in drug product development and test method development must understand the regulatory, scientific, and business requirements for good method validation and effective method transfer.

The objective of method transfer is to ensure that the recipient laboratory is well trained and qualified to run the method, in order for both client and recipient laboratories to obtain comparable results and for the method to be shown to run successfully. The development of robust methods and the documentation of precise standard operating procedures (SOPs) is the best way to ensure successful method transfer.

How Patni Can Help
Patni works in partnership with its clients, addressing requirements on an individual basis. The method transfer capabilities of Patni help manage the challenges associated with method transfer. Project design is based on the nature of the product, the analytical objectives to be achieved, and the phase of product development.

Patni Focus Areas