How Does Japan Validate Analytical Methods During Drug Quality Audits?

Japan validates analytical methods during drug quality audits by adhering to guidelines set by the Pharmaceuticals and Medical Devices Agency (PMDA). This involves assessing method accuracy, precision, specificity, linearity, and robustness. Validation ensures compliance with international standards, such as ICH guidelines, to maintain drug safety and efficacy throughout the audit process.

Leave a Reply

You must be logged in to post a comment.