These observations, ranging from high-potency drugs to microbial risks, require a proactive and comprehensive approach. Azzur Group’s expertise empowers pharmaceutical manufacturers to surpass regulatory expectations and enhance compliance.
Introduction
In a rapidly evolving regulatory landscape, Azzur Group leads the charge in refining cleaning validation programs to encompass worst case scenarios.
The recent trend in the FDA warning letters underlines the need to refine cleaning validation programs by incorporating worst case scenarios into the assessment process.
These scenarios involve various aspects of drug properties, cleaning methodologies, and microbial risks. This whitepaper provides a comprehensive plan to systematically address these challenges.
