Lifecycle and Validation of Analytical Procedures FDA ICH and USP

The life cycle of an analytical method includes its design, development, validation (covering instrumental qualification, continuous performance verification, and method transfer), and finally, the retirement of the method along with archiving all related documentation. The lifetime of an analytical method may vary—sometimes it is temporary, while in other cases, long-term use may change due to expected shifts in sample composition, purpose, or operations.

Instead of developing separate methods for each stage of change, similar methods can be validated and applied. The requirements of the FDA and ICH related to this will also be addressed.

The goal is to design a methodology that remains valid without needing revalidation, even when changes occur in the method, sample, results (both qualitative and quantitative), or in the scope and use of those results.

The principles and scope, apparatus and equipment, operating parameters, reagents and standards, sample preparation, control standards preparation, procedure, system suitability, calculations, and data reporting are all included.

Revalidation during a method’s intended period of use is often costly and time-consuming, but these efforts can sometimes be reduced or even avoided.

• Laboratory method operators
• Method- development chemists
• Lab supervisors
• Others.