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.
"Calif[f], 70, is a well-regarded cardiologist and researcher who takes the helm at the FDA for a second time 13 months after it last had a permanent leader."
Jennifer Payne - President, SkillsPlus International Inc. | SkillsPlus Intl Inc. announces its new president, Jennifer Payne. She assumes responsibility for all administrative needs, and for managing CGMP contract trainers.
The team at SkillsPlus International Inc. | Learn more about our team, and visit our new website: https://skillsplusinc.com/about.htm
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.