FDA Requires Drug Companies to Update Analytical Procedures as Part of Life-Cycle Management

The FDA has finalized a new guidance recommending continuous refinement of analytical procedures and methods validation over the lifecycle of drug products based on new information collected over time. These recommendations will be additional to drug product quality documentation requirements that are standard during application for market approval or when there is change in the manufacturing process. Currently, each NDA, BLA and ANDA must include the analytical procedures necessary to ensure the identity, strength, quality, purity, and potency of both the drug substance and drug product along with data demonstrating that the procedures used meet proper standards of accuracy, sensitivity, specificity, reproducibility and suitability for their intended purpose. Applicants are also expected to conduct trend analysis on the performance of the methods submitted at least annually. Now, the FDA would like applicants to periodically evaluate the appropriateness of an approved product’s analytical methods and consider new or alternative methods to incorporate new information and risk assessment as well as new technologies that may ensure greater confidence in product quality. In anticipation of life cycle changes in analytics, FDA is also recommending the retention of an appropriate number of samples that represent the marketed product and, when possible, pivotal clinical trial material to allow for comparative studies. If the reassessments lead to changes in an analytical procedure or replacement with a new method, a new validation exercise, an analytical method comparability study, or a combination of these exercises will need to be considered. While the guidance does not address methods validation for investigational new drug application (IND), it advises sponsors preparing INDs to consider its recommendations.