Food Science and Technology

Points to Consider in Quality Control Method Validation and Transfer View PDF by  Weijun Li Thursday, March 14, 2019  12:52 pm Figure 1: Analytical method lifecycle The concept of an analytical lifecycle has been well received in the biopharmaceutical industry. In 2016, the US Pharmacopeia (USP) advocated for lifecycle management of analytical procedures ( 1 ) and defined its three stages: method design development and understanding, qualification of the method procedure, and procedure performance verification. The US Food and Drug Administration (FDA) has published guidance on process validation with a similar division into three stages: process design, process performance qualification, and process performance verification ( 2 ). For a manufacturing process, process performance must be monitored. For an analytical method, a method procedure performance must be monitored. Following the analytical lifecycle concept, an analytical method lifecycle can be di...