The validation of media and buffer mixing is a continuing area of resource constraint in the pharmaceutical industry. These validations require materials, validation associates’ time, and the use of equipment and processing areas. This article proposes a risk-based life cycle for minimizing mixing validation resource inputs, with the objective of optimizing validation efforts through the use...
Pressures on pharmaceutical companies from regulators, governments, and competitors are forcing them to closely examine expenditure. But making cost savings while ensuring the standard of products remains high is problematic. Recent developments in process analytical technology have opened a door to reduced manufacturing costs without compromising product quality.