This guidance for industry provides the Agency’s current thinking on how to evaluate out-of-specification (OOS) test results: Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production - Level 2 revision.
Tag: guidance
FDA Issues New DSCSA Guidances
To help our stakeholders understand these requirements, the FDA is issuing guidance documents intended to assist trading partners in complying with the law and achieving a safer, more secure and more trusted drug supply chain.
FDA Issues COVID-19 Public Health Emergency Questions and Answers
FDA Guidance - COVID Public Health Emergency Q and A | FDA cGMP QSR GMP Training by SkillsPlus Intl Inc