Biotechnological Method Validation SOP Revisions in Alignment with Evolving ICH Guidelines

The biotechnological industry can be considered one of the most progressive industries, as it is constantly experimenting with the boundaries of science and technology. In this fast-changing environment, method validation SOPs are crucial because they act as guidelines to achieve acceptable levels of confidence in the analytical data obtained in different phases of biopharmaceutical development and manufacture. Nevertheless, the pace of change in technologies and regulatory requirements becomes an essential concern to ensure that the established and implemented SOPs are updated in accordance with the ICH guidelines. However, due to the constant growth of biotechnology in the industry, it is necessary to focus on the main aspects of method validation. Method validation SOPs are of such immense importance because they guard against using the right analytical methods to establish biopharmaceutical products’ quality, safety, and efficacy. However, rapid technological advancements and ever-changing regulatory standards challenge firms to guarantee accurate validation processes.