GMP Sign-Off Workflows for Stability Protocols
In the pharmaceutical industry, the stability protocol is the cornerstone of shelf-life determination and long-term product quality assurance. However, a well-designed protocol is only effective if it undergoes rigorous review and approval aligned with Good Manufacturing Practices (GMP). In this article, we explore the end-to-end GMP-compliant sign-off workflow for stability protocols, covering roles, responsibilities, documentation…
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